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State Food and Drug Administration Decree of the State Food and Drug Administration No. 16 The "Measures for the Administration of Medical Device Registration", which were deliberated and adopted at the working meeting of the State Food and Drug Administration on May 28, 2004, are hereby promulgated, and shall come into force as of the date of promulgation. Zheng Xiaoyu, Director General August 9, 2004 Measures for the Administration of Medical Device Registration Chapter I General Provisions
Article 1 These Measures are formulated in accordance with the "Regulations on the Supervision and Administration of Medical Devices" in order to regulate the administration of medical device registration, and ensure the security and utility of medical devices.
Article 2 Whoever sells or uses medical devices inside the People's Republic of China shall apply for registration in accordance with these Measures, and no medical device shall be sold or used without being approved for registration.
Article 3 Medical device registration means the process of carrying out systematic appraisal pursuant to legal procedures on the security and utility of the medical devices to be sold on the market and to be used, so as to decide whether or not to approve their sale and use.
Article 4 The State administers medical devices by classified registration. The medical devices on Category I inside China shall be examined by the (food) drug administration at the level of a city divided into districts, and upon approval, a medical device registration certificate shall be issued to the party concerned. The medical devices on Category II inside China shall be examined by the (food) drug administration of the province, autonomous region, or municipality directly under the Central Government, and upon approval, a medical device registration certificate shall be issued to the party concerned. The medical devices on Category III inside China shall be examined by the State Food and Drug Administration, and upon approval, a medical device registration certificate shall be issued to the party concerned. The medical devices from abroad shall be examined by the State Food and Drug Administration, and upon approval, a medical device registration certificate shall be issued to the party concerned. The registration of medical devices from the regions of Taiwan, Hong Kong and Macao shall, unless otherwise prescribed by these Measures, be handled with reference to that for medical devices from abroad. The validity period for a medical device registration certificate is 4 years.
Article 5 The medical device registration certificate shall be uniformly printed and made by State Food and Drug Administration, with the corresponding contents to be filled in by the (food) drug administration responsible for examination, approval and registration. The registration number shall be laid out as follows: กม(กม) 1 (shi) yao jian xie (กม2) zi กมกมกมกม3 No. กม4กมกม5กมกมกมกม6. Among which, กม1 shall be the shortened form of the locality of the registration and approval organ: For the medical devices on Category III inside China, medical devices from abroad and those from the regions of Taiwan, Hong Kong and Macao, such shortened form shall be indicated as the character of "Guo", which means national; For the medical devices on Category II inside China, such shortened form shall be indicated as that of the province, autonomous region, or municipality directly under the Central Government where the registration and approval organ is located; For the medical devices on Category I inside China, such shortened form shall be indicated as that of the province, autonomous region, or municipality directly under the Central Government where the registration and approval organ is located, plus that of the administrative area at the level of city divided into districts, namely, กมกม1 (if there is no corresponding administrative area at the level of city divided into districts, it shall only be the shortened form of the province, autonomous region, or municipality directly under the Central Government); กม2 shall be the registration form (whether approved [zhun], imported [jin] or permitted [xu]): The form of being "Approved" shall apply to the medical devices inside China; The form of being "Imported" shall apply to the medical devices from abroad; The form of being "Permitted" shall apply to the medical devices from the regions of Taiwan, Hong Kong and Macao; กมกมกมกม3 shall be the year in which the registration is approved; กม4 shall be the category of product administration; กมกม5 shall be the number of the product variety; กมกมกมกม6 shall be the registration sequence number. A medical device registration certificate shall be attached with a "Medical Device Registration Form" (see Appendix 1 of these Measures), which shall be used simultaneously with the medical device registration certificate.
Article 6 A manufacturing enterprise may obtain a medical device registration certificate after its application for medical device registration has been approved, and shall bear the corresponding legal obligations. A person handling an application for medical device registration shall be entrusted by a manufacturing enterprise, have the corresponding professional expertise, and be familiar with the laws, regulations, rules and technical requirements on medical device registration and administration. A manufacturing enterprise outside China shall, when applying for the registration of medical devices from abroad, appoint an institution inside China as its agent, which shall assume legal liabilities accordingly; in addition, the manufacturing enterprise outside China shall entrust a legal entity inside China with corresponding qualification or entrust its office in China to undertake after-sale services for the medical devices.
Article 7 With respect to the medical devices under application for registration, there shall be applicable product standards. For this purpose, national standards or industry standards may be adopted or standards for registered products may be formulated, however the standards for registered products may not be lower than national standards or industry standards. The standards for registered products shall be compiled in accordance with the requirements prescribed by the State Food and Drug Administration for standard administration of medical devices.
Article 8 A manufacturing enterprise applying for registration of medical devices on Category II or Category III shall meet the production conditions prescribed by the State Food and Drug Administration or the relevant quality system requirements.
Chapter II Medical Device Registration Test
Article 9 For the medical devices on Categories II and III, registration test shall be carried out by a medical device testing institution accredited by the State Food and Drug Administration jointly with the State General Administration of Quality Supervision, Inspection and Quarantine, and only after the medical devices have been tested as meeting the applicable product standards may they be used for clinical trial or apply for registration. The catalogue of the medical device testing institutions accredited by the State Food and Drug Administration jointly with the State General Administration of Quality Supervision, Inspection and Quarantine (hereinafter referred to as medical device testing institutions) shall be separately promulgated.
Article 10 A medical device testing institution shall, within the testing scope recognized by the State Food and Drug Administration and the State General Administration of Quality Supervision, Inspection and Quarantine, and according to the applicable product standards for manufacturing enterprises (including applicable national standards, industry standards, or standards made by the manufacturing enterprise for registered products), carry out registration test for the products under application, and issue a testing report. The medical devices which have not been included into the scope of authorized test by medical device testing institutions shall be tested by a capable testing unit appointed by a corresponding registration and approval organ. The registration test of medical devices from abroad shall apply the "Provisions on Registration Test of Medical Devices from Abroad".
Article 11 The products tested within one registration unit shall be the typical products which can represent security and utility of other products within this same registration unit.
Article 12 With respect to the products of the same category which are produced by one manufacturing enterprise with the same raw materials, if the production techniques and anticipated purposes remain unchanged, no biocompatibility trial needs to be carried out during the biological evaluation of the products at the time of re-registration. With respect to the products of the same category which are produced by one manufacturing enterprise with raw materials having passed biological evaluation, if the production process or anticipated purpose remains unchanged, or if there is no new potential biological risks, no biocompatibility trial needs to be carried out during the biological evaluation of the products at the time of application for registration.
Article 13 Those applying for medical device registration under Category II or Category III may, when meeting the following conditions simultaneously, be exempted from registration test: (1) The basic theory, main functions and structure, materials used, and anticipated purposes of the medical devices under application for registration and those of the medical devices already approved for registration from the same enterprise fall in the same category; (2) The manufacturing enterprise has already passed the inspection on the quality management standards for the production of medical devices or has obtained the quality system certification for medical devices, and is able to provide the testing report accredited by the original institution which has examined the production conditions of the enterprise; (3) When compared with products on the same category which have been approved for registration and have passed registration test, if there is no change in the security or utility with the medical devices under application for registration, or although there is change in the security or utility, both the changed part and the part causing other relevant changes in the security or utility of the products have passed the test carried out by the medical device testing institution; (4) No serious ill incident is found with the products which have been approved for registration on the same category by the same enterprise under the monitoring conducted as prescribed; (5) No records of disqualification are kept on its products of the same category which have been approved for registration within 1 year from the selective supervision and inspection by the (food) drug administration on the quality of the product; and (6) The medical devices from abroad have been approved by the corresponding governmental medical device authority to be put on market.
Article 14 Those applying for re-registration of medical devices or products on Category II or Category III may, when meeting the following conditions simultaneously, be exempted from registration test: (1) The basic theory, main functions and structure, materials used, and anticipated purpose of the medical devices under application for re-registration and those of its medical devices approved for registration fall in the same category; (2) The manufacturing enterprise has passed the inspection on its quality management rules for production of medical devices or has obtained the quality system certification for medical devices, and is able to provide the testing report accredited by the original institution for examination of enterprise production conditions; (3) When compared with the original registered products which have passed registration test, there is no change in the security or utility with the medical devices under application for re-registration, or although there is change in security or utility, both the changed part and the part causing other relevant changes in the security or utility of the products have passed the test carried out by the medical device testing institution; (4) No serious ill incident is found under the monitoring conducted as prescribed upon the medical devices under application for re-registration within the original validity period for the medical device registration certificate; and (5) No records of disqualification are kept on its originally registered medical devices within 1 year from the selective product quality supervision and inspection made by the (food) drug administration.
Article 15 With respect to large medical devices which have been approved by the medical device authority of a foreign government to be put on the market, but whose installation place is under particular requirements and whose testing is difficult, the manufacturing enterprise may apply for temporary delay of testing, and apply for supplementary testing after obtaining the medical device registration certificate. With respect to the products whose testing is temporarily delayed according to the preceding paragraph and which are approved for registration, the manufacturing enterprise must complete the registration test after the first medical device enters into China and before it is put into use. Only after they have been tested as qualified may they be put into use.
Chapter III Clinical Trial of Medical Devices
Article 16 Those manufacturing enterprises applying for registration of medical devices on Category II or Category III shall submit clinical trial documents. The method of submitting clinical trial documents shall be in accordance with the "Provisions on Itemization of Clinical Trial Documents for Medical Device Registration" (see Appendix 12 of these Measures).
Article 17 Those enterprises carrying out clinical trial of medical devices inside China shall strictly implement the "Provisions on Clinical Trial of Medical Devices".
Article 18 For the medical devices whose clinical trial is carried out inside China, the clinical trial documents shall include clinical trial contract, clinical trial program and clinical trial report. When deeming it as necessary, a (food) drug administration may require the manufacturing enterprise to submit the directions for clinical trial, a consent letter indicating the knowledge about the information, and the original clinical trial records.
Chapter IV Application for, Examination and Approval of Medical Device Registration
Article 19 When applying for medical device registration, the applicant shall, according to the classification of medical devices, file an application to the corresponding (food) drug administration as prescribed in Article 4 of these Measures, and shall fill out the application form for medical device registration, and submit the application documents pursuant to the corresponding requirements in Appendix 2, Appendix 3, Appendix 6, Appendix 8 or Appendix 9 of these Measures. The application documents shall be in Chinese. When submitting the application documents translated from a foreign language, the original text shall be provided at the same tome. The medical device directions submitted by the applicant shall conform to the "Provisions on the Administration of Medical Device Directions, Labels and Packing Marks". The applicant shall be responsible for the authenticity of all contents in the application documents.
Article 20 The (food) drug administration shall, after receipt of an application, deal with the application in light of the following circumstances: (1) If the matters in application do not fall in the scope of its powers in accordance with the law, it shall immediately make a decision on not accepting the application, and inform the applicant to apply to other relevant administrative organ; (2) If any error which may be corrected on site exists in the application documents, it shall permit the applicant to make corrections on site; (3) If the application documents are incomplete or do not meet the requirements for formal examination, it shall issue a "Notice on Supplementing Documents" to the applicant on site or within 5 working days, and inform the applicant once and for all the contents to be supplemented. If it fails to inform the applicant within the time limit, it shall be regarded as having accepted the application as of the date when the application documents are received; (4) If the application documents are complete and meet the requirements for formal examination, or the applicant has submitted all the supplemented application documents as required, the application shall be regarded as having been accepted. The (food) drug administration shall, whether or not accepting the application for medical device registration, issue a "Notice on Accepting the Application" or "Notice on Not Accepting the Application" affixed with its special stamp and indicated with the date.
Article 21 A (food) drug administration shall, after accepting the application for medical device registration, make substantive examination on the application within the time limit prescribed in Article 22 of these Measures, and make a written decision on whether to approve the registration. If the application is examined as conforming to the provisions and the registration is approved, the (food) drug administration shall issue the medical device registration certificate within 10 working days as of approving the decision in writing. If the application is examined as not conforming to the provisions, the (food) drug administration shall make a written decision on not approving the registration, state the reason, and meanwhile inform the applicant of the right to lawfully apply for administrative reconsideration or to bring an administrative lawsuit.
Article 22 The (food) drug administration at the level of a city divided into districts shall, within 30 working days as of accepting an application, make a decision on whether to approve the registration. The (food) drug administration of a province, autonomous region, or municipality directly under the Central Government shall, within 60 working days as of accepting an application, make a decision on whether to approve the registration. The State Food and Drug Administration shall, within 90 working days as of accepting an application, make a decision on whether to approve the registration. If, in the process of examination of an application for registration, it is necessary to hold a test, expert appraisal or hearing, the time needed for it shall not be calculated into the time limit prescribed in this Article. The (food) drug administration shall inform the applicant in writing of the time needed.
Article 23 With respect to the medical devices from abroad which are not permitted to be put on market, the applicant may apply for registration with reference to the requirements for technical examination for registration of products of the same category inside China (see Appendix 8 and Appendix 9 of these Measures for necessary documents to be submitted).
Article 24 A (food) drug administration shall, when making technical examination on the application documents for medical device registration, send a one-time written notice on supplementing documents, if the manufacturing enterprise needs to supplement documents. A manufacturing enterprise shall, within 60 working days, supplement all the documents as required by the notice for once, and the time for supplementing documents shall not be calculated into the time limit for the (food) drug administration to make substantive examination. If the manufacturing enterprise fails to supplement the documents within the prescribed time limit and has no justifiable reason, the examination shall be terminated.
Article 25 Where the examination of an application for registration is terminated, the applicant may not file a second application within 6 months as of the termination of the examination.
Article 26 Where a manufacturing enterprise has any objections to the contents in the notice on supplementing documents, it may, within the prescribed time limit, propose written opinions to the (food) drug administration, state the reasons, and provide technical support documents, so that the (food) drug administration may make a decision from examination.
Article 27 The registration units of medical device products shall, in principle, be divided on the basis of technical structure, performance index and anticipated purpose.
Article 28 With respect to the medical devices registered as components, the applicant shall state the recommended product to be used along with such components, as well as the name, model and specifications of such components. For a whole machine assembled with components approved for registration, the whole machine registration procedures must be fulfilled. With respect to the medical devices registered as a whole machine, the enterprise involved shall, when applying for registration, list the main configurations. In the event that the performance or specifications of the components of a certain main configuration are changed, the manufacturing enterprise involved shall make re-registration of the whole machine. With respect to the medical devices registered as a whole machine, if the combined components listed in the column of "Product Performance, Structure and Composition" in the attached schedule of the medical device registration certificate are sold independently on the condition that neither the form of combination nor the anticipated purpose is changed, specific registration may be exempted.
Article 29 A (food) drug administration shall announce the conditions, procedures and time limit for the medical device registration, a catalogue of all documents to be submitted, and a sample version of the application letter, etc. on the administrative organ's website as well as in the work place for medical device registration.
Article 30 A (food) drug administration shall, when examining an application for medical device registration, announce the process of the examination and result of approval. The applicant and an interested party may submit its/his written opinions on the matters directly related to its/his major benefits, make statements and contentions.
Article 31 The State Food and Drug Administration shall regularly publish on its governmental website the catalogue of the medical devices which have been approved for registration, for the public's reference.
Article 32 Where an application for medical device registration is directly involved with the major benefit relationship between the applicant and others, the (food) drug administration shall inform the applicant and the interested party that it/he may, in accordance with the laws, regulations, and other provisions of the State Food and Drug Administration, have the right to apply for a hearing. When examining an application for medical device registration, the (food) drug administration shall announce to the public the major issues for permission which it deems to be involved with public benefits, and shall hold a hearing.
Chapter V Re-registration of Medical Devices
Article 33 When the validity period of a medical device registration certificate has expired, and the manufacturing enterprise needs to continue selling or using the medical devices, it shall, within 6 months prior to the expiry of the validity period of the medical device registration certificate, apply for re-registration. If it fails to do so within the time limit, registration test on the products shall be made at the time of re-registration.
Article 34 In the event of any change in the following contents on a medical device registration certificate, the manufacturing enterprise shall apply for modification and re-registration within 30 days as of the change: (1) model and specifications; (2) address of production; (3) product standards; (4) product performance, structure and composition; (5) scope of application of the products.
Article 35 If, within the validity period of a medical device registration certificate, the category for administration of the product is changed, the manufacturing enterprise shall, within 6 months, apply to the corresponding (food) drug administration for modification and re-registration on the basis of the modified class.
Article 36 Whichever manufacturing enterprise applies for re-registration of medical devices shall fill out the medical device registration application form, and shall, pursuant to the requirements in Appendix 4, Appendix 5 or Appendix 7 of these Measures, submit application documents to the (food) drug administration. The procedures for acceptance, examination and approval of applications for re-registration shall, in case of no relevant provisions in this Chapter, be governed by the relevant provisions of Chapter IV of these Measures.
Article 37 Medical devices under any of the following circumstances shall not be re-registered: (1) The requirements proposed according to the relevant provisions of the State Food and Drug Administration by the (food) drug administration at the time of approval of being put on market have not been fulfilled; (2) The medical devices are re-appraised by the State Food and Drug Administration to be eliminated; (3) The medical device registration certificate has been revoked in accordance with the "Regulations on the Supervision and Administration of Medical Devices".
Chapter VI Modification and Re-issuance of Medical Device Registration Certificates
Article 38 Where the contents of a medical device registration certificate has any of the following changes, the manufacturing enterprise shall, within 30 days as of the occurrence of the change, apply for modification of the medical device registration certificate: (1) change of the name of the manufacturing enterprise, but without any change with the entity; (2) change of the registered address of the manufacturing enterprise; (3) literal change of the production address; (4) literal change of the product name or commodity name; (5) literal change of the model or specifications; (6) literal change of the title or code of the product standards; (7) change of the agent; or (8) change of the after-sale service office.
Article 39 Those manufacturing enterprises applying for the modification of a medical device registration certificate shall fill out the application form for modification of the medical device registration certificate, and shall, pursuant to the requirements in Appendix 10 of these Measures, submit the relevant documents and statements to the original registration and approval organ. The original registration and approval organ shall carry out a formal examination on the application documents, inform once and for all either on site or within 5 working days the applicant of all the contents to be supplemented, and issue the "Notice on Accepting the Application" to the applicant who meets the requirements.
Article 40 The original registration and approval organ shall, within 20 working days after accepting the application for modification, make a written decision on whether to approve the modification or not. If the application is examined as qualified for modification, the original registration and approval organ shall issue a modified medical device registration certificate, and write off the original medical device registration certificate. If, however, the application is examined as unqualified, the original registration and approval organ shall make a written decision on not approving the modification, state the reasons, and meanwhile inform the applicant of the right to lawfully apply for administrative reconsideration or to bring an administrative lawsuit. A modified medical device registration certificate shall have the original number as its number, followed by the word "modified" in brackets. The expiry date of the validity period for a modified medical device registration certificate shall be the same as that for the original medical device registration certificate. The enterprise concerned shall apply for re-registration at the expiry of the validity period.
Article 41 Where a medical device registration certificate is lost or damaged, the manufacturing enterprise shall, pursuant to the requirements in Appendix 11 of these Measures, submit the relevant documents and statements, and apply to the original registration and approval organ for re-issuance of the certificate.
Chapter VII Supervision and Administration
Article 42 The (food) drug administration responsible for examination and approval of medical device registration shall carry out examination and grant approval pursuant to the prescribed procedures, and make a decision on whether to approve the registration or not. Any (food) drug administration examining and approving the registration in violation of provisions shall be lawfully investigated for administrative liabilities.
Article 43 Where a local (food) drug administration at the level of city divided into districts or above approves medical device registration by violating these Measures, the (food) drug administration at the higher level shall order it to make a correction within a time limit. If it fails to make a correction within the time limit, the (food) drug administration at the higher level may directly revoke the medical device registration certificate by announcement. The medical devices whose medical device registration certificate has been revoked may not be sold or used any longer. If they have been sold or used, they shall be treated by the enterprise under the supervision of the local (food) drug administration at the county level or above.
Article 44 A (food) drug administration at the provincial level or above shall make technical re-appraisal on the medical devices on market, and shall, on the basis of the result from technical appraisal, make a decision on revoking the medical device registration certificate of the medical devices which cannot achieve the anticipated purpose of use and whose security and validity can not be guaranteed. In addition, the said (food) drug administration shall announce the revocation to the public. The medical devices whose medical device registration certificate has been revoked may not be sold or used any longer. If they have been sold or used, they shall be treated by the enterprise under the supervision of the local (food) drug administration at the county level or above.
Article 45 In case of any of the circumstances in Article 70 of the "Administrative License Law of the People's Republic of China", the original registration and approval organ shall lawfully write off the medical device registration certificate.
Chapter VIII Legal Liabilities
Article 46 If any enterprise tries to obtain a medical device registration certificate by providing false proofs, documents or samples, etc., or by such foul means as fraud or bribery, etc., in violation of these Measures, the registration and approval organ shall not accept its application or grant the registration, and shall issue a warning and refuse to accept its application for medical device registration within 1 year. The medical device registration certificate which has been fraudulently obtained shall be revoked, and the enterprise's application for medical device registration shall not be accepted within 2 years; in addition, it shall be penalized in accordance with Article 40 of the "Regulations on the Supervision and Administration of Medical Devices".
Article 47 Whichever enterprise alters, speculates in, leases or lends a medical device registration certificate, or illegally transfers a medical device registration certificate in any other form, shall be ordered by the (food) drug administration at the county level or above to make corrections, and may be imposed upon a fine of not more than 30,000 Yuan.
Article 48 Whichever enterprise fails to lawfully apply for re-registration of medical devices before selling the medical devices, or sells medical devices in disagreement with the contents specified in the registration certificate, or produce directions, labels or packing marks, etc. in disagreement with the contents specified in the medical device registration certificate, in violation of Article 33 , Article 34 or Article 35 of these Measures, shall be penalized by the (food) drug administration at the county level or above in accordance with the provisions concerning practicing related business operations with no medical device registration certificate as prescribed in the "Regulations on the Supervision and Administration of Medical Devices".
Article 49 Whichever enterprise fails to lawfully apply for modification of a medical device registration certificate in violation of Article 38 of these Measures by shall be ordered by the (food) drug administration at the county level or above to make a correction within a time limit or be imposed upon a warning. If it fails to make a correction within the time limit, it may be imposed upon a fine of not less than 5,000 Yuan but not more than 10,000 Yuan.
Article 50 Where any medical device registered in accordance with Article 15 of these Measures is subject to registration test, but it is put into use before the registration test is completed in accordance with the provisions, the State Food and Drug Administration shall revoke the medical device registration certificate, announce the revocation, and keep it into the enterprise's honesty and credibility archives. Where a product is tested as unqualified from the registration test, its medical device registration certificate shall be revoked by the State Food and Drug Administration.
Chapter IX Supplementary Provisions
Article 51 Manufacturing enterprise means an organization that launches its products to the market in its own name, and bear the final legal liabilities for such products.
Article 52 Registered products mean the medical devices approved to be registered, and the products whose directions, labels or packing marks, etc. are in conformity with the said contents specified in the medical device registration certificate.
Article 53 All medical devices produced within the validity period of the medical device registration certificate shall be deemed as products with certificate.
Article 54 With respect to the regents for ecto-body diagnosis administered under medical device registration, the provisions on their registration administration shall be separately formulated by the State Food and Drug Administration.
Article 55 The responsibility to interpret these Measures shall remain with the State Food and Drug Administration.
Article 56 These Measures shall come into force on the date of their promulgation. The "Measures for the Administration of Medical Device Registration" promulgated by the State Drug Administration on April 5, 2000 shall be repealed simultaneously. Appendices: 1. Format of Medical Device Registration Form (Omitted) 2. Requirements of Application Documents for Registration of Medical Devices on Category I Inside China 3. Requirements of Application Documents for Registration of Medical Devices on Categories II and III Inside China 4. Requirements of Application Documents for Re-registration of Medical Devices on Category I inside China 5. Requirements of Application Documents for Re-registration of Medical Devices on Categories II and III inside China 6. Requirements of Application Documents for Registration of Medical Devices from Abroad 7. Requirements of Application Documents for Re-registration of Medical Devices from Abroad 8. Requirements of Application Documents for Initial Registration of the Medical Devices on Category I from Abroad Which Have Not Been Permitted To Be on Market 9. Requirements of Application Documents for Initial Registration of the Medical Devices on Categories II and III from Abroad Which Have Not Been Permitted To Be on Market 10. Requirements of Application Documents for Modification of a Medical Device Registration Certificate 11. Requirements of Application Documents for Re-issuance of a Medical Device Registration Certificate 12. Provisions on Itemization of Clinical Trial Documents for Medical Device Registration Requirements of Application Documents for Registration of Medical Devices on Category I inside China (1) Application form for registration of medical devices inside China;
(2) Qualification certificate of the medical device manufacturing enterprise: counterpart of its business license;
(3) Applicable product standards and remarks: If national standards or industry standards are adopted as the applicable standards for the products, the manufacturing enterprise shall submit the document on the adopted national standards or industry standards; standards for registered products shall be affixed with the stamp of the manufacturing enterprise. The manufacturing enterprise shall provide a declaration that the products under application meet the national standards or industry standards, a declaration that the manufacturing enterprise shall bear quality liabilities after the products have been put on market, and a statement on defining the relevant product models and specifications. "Stamp" herein means either the enterprise stamp, or the signature of its legal representative or responsible person plus the enterprise stamp (same as below where medical devices inside China are involved);
(4) Testing report on full performance of the products;
(5) Statement on the existing resource conditions for the enterprise to produce products and on its quality management capacity (including testing method);
(6) Medical device directions;
(7) Declaration of self-warranty on the authenticity of the submitted documents: which includes a list of the submitted documents, and the commitments of the manufacturing enterprise on bearing its legal liabilities. Requirements of Application Documents for Registration of Medical Devices on Category II and Category III inside China (1) Application form for registration of medical devices;
(2) Qualification certificate of the medical device manufacturing enterprise: which includes the permit of the manufacturing enterprise, a counterpart of its business license, and the products under application shall fall within the production scope of the permit verified by the manufacturing enterprise;
(3) Technical report of the products: which shall include at least such contents as the technical index, or the basis for determining the main performance requirements;
(4) Security risk analysis report: which shall be complied according to the standards of YY0316 "Medical Device Risk Analysis", and shall include the analysis in five respects, namely, energy harm, biological harm, environmental harm, harm related to use and harm caused from invalidation, careless maintenance or ageing, and corresponding preventive measures, as well;
(5) Applicable product standards and remarks: If national standards or industry standards are adopted as the applicable standards for the products, the manufacturing enterprise shall submit the document on the adopted national standards or industry standards; standards for registered products shall be affixed with the stamp of the manufacturing enterprise. The manufacturing enterprise shall provide a declaration that the products under application meet the national standards or industry standards, a declaration that the manufacturing enterprise shall bear quality liabilities after the products have been on market, and a statement on defining relevant product models and specifications.
(6) Report on self-test of product performance: The items of self-test of product performance shall be the items of ex-factory test prescribed in the standards for registered products, which shall be signed by the principal tester, the responsible person for principal test, or the verifier. If national standards or industry standards are applied, the manufacturing enterprise shall supplement the items of ex-factory test determined by it.
(7) Product registration test report issued by the medical device testing institution: With respect to the medical devices which need to be used for clinical trial, the manufacturing enterprise shall submit a testing report issued by a medical device testing institution within half a year prior to the beginning of the clinical trial. With respect to the medical devices which do not need to be used for clinical trial, the manufacturing enterprise shall submit a testing report issued by a medical device testing institution within 1 year prior to the acceptance of the application for registration. Where Article 11 , Article 12 , Article 13 or Article 14 of these Measures is applied, the applicant shall provide the corresponding documents of statement;
(8) Documents on clinical trial of the medical devices (see Appendix 12 of these Measures for specific method of submission);
(9) Medical device directions;
(10) Effective proof documents on product quality system assessment (certification) --- a corresponding quality system assessment report shall be provided in light of the requirements for different products: 1. The system assessment report within the validity period, which is affixed with the stamp by the (food) drug administration of the province, autonomous region, or municipality directly under the Central Government; 2. The inspection report on quality management rules for medical device production, or the quality system certificate for the medical devices; 3. If the state has applied implementation rules for production, a report on acceptance upon inspection under such implementation rules shall be submitted;
(11) Declaration of self-warranty on the authenticity of the submitted documents: which includes a list of the submitted documents, and commitment of the manufacturing enterprise on bearing legal liabilities. Requirements of Application Documents for Re-registration of Medical Devices on Category I inside China (1) Application form for registration of medical devices inside China;
(2) Qualification certificate of the medical device manufacturing enterprise: counterpart of its business license:
(3) Original medical device registration certificate: Under the circumstance in Article 33 of Chapter V of these Measures, the manufacturing enterprise shall submit a photocopy of the original medical device registration certificate; while under any of the circumstances in Article 34 or Article 35 of Chapter V of these Measures, it shall submit the original copy of the original medical device registration certificate;
(4) Applicable product standards and remarks: If national standards or industry standards are adopted as the applicable standards for the products, the manufacturing enterprise shall submit the document about the adopted national standards or industry standards; standards for registered products shall be affixed with the stamp of the manufacturing enterprise. The manufacturing enterprise shall provide a declaration that the products in application meet the national standards or industry standards, a declaration that the manufacturing enterprise shall bear quality liabilities after the products have been on market, and a statement on defining the relevant product models and specifications.
(5) Follow-up report on product quality;
(6) Medical device directions;
(7) Under any of the circumstances in Article 34 of Chapter V of these Measures, the manufacturing enterprise shall submit a corresponding statement of the facts and the proof documents;
(8) Declaration of self-warranty on the authenticity of the submitted documents, Which should include a list of the submitted documents, and the commitment of the manufacturing enterprise on bearing legal liabilities. Requirements of Application Documents for Re-registration of Medical Devices on Category II and Category III inside China (1) Application form for registration of medical devices inside China;
(2) Qualification certificate of the medical device manufacturing enterprise: which includes the permit of the manufacturing enterprise, a counterpart of its business license, and the products under application shall fall within the production scope of the permit verified by the manufacturing enterprise;
(3) The original medical device registration certificate: Under the circumstance in Article 33 of Chapter V of these Measures, the manufacturing enterprise shall submit a photocopy of the original medical device registration certificate; while under any of the circumstances in Article 34 or Article 35 of Chapter V of these Measures, it shall submit the original copy of the original medical device registration certificate;
(4) Product registration test report issued by the medical device testing institution: With respect to the medical devices which need to be used for clinical trial, the manufacturing enterprise shall submit a testing report issued by a medical device testing institution within half a year prior to the beginning of the clinical trial. With respect to the medical devices which do not need to be used for clinical trial, the manufacturing enterprise shall submit a testing report issued by a medical device testing institution within 1 year prior to the acceptance of the application for registration Where Article 11 , Article 12 , Article 13 or Article 14 of these Measures is applied, the applicant shall provide the corresponding documents of statement;
(5) Applicable product standards and remarks: If national standards or industry standards are adopted as the applicable standards for the products, the manufacturing enterprise shall submit the document on the adopted national standards or industry standards; standards for registered products shall be affixed with the stamp of the manufacturing enterprise. The manufacturing enterprise shall provide a declaration that the products under application meet the national standards or industry standards, a declaration that the manufacturing enterprise shall bear quality liabilities after the products have been on market, and a statement on defining the relevant product models and specifications.
(6) Follow-up report on product quality: The follow-up quality report issued by the manufacturing enterprise on the products which have been used in a medical institution in China shall include a statement on the ill incident monitoring;
(7) Medical device directions;
(8) Effective proof documents on product quality system assessment (certification) --- a corresponding quality system assessment report shall be provided in light of the requirements for different products: 1. The system assessment report within the validity period, which is affixed with the stamp by the (food) drug administration of the province, autonomous region, or municipality directly under the Central Government; 2. The inspection report on quality management rules for medical device production, or the quality system certificate for the medical devices; 3. If the state has applied implementation rules for production, a report on acceptance upon inspection under such implementation rules shall be submitted;
(9) Under any of the circumstances in Article 34 of Chapter V of these Measures, the manufacturing enterprise shall submit a corresponding statement of the facts and the proof documents;
(10) Declaration of self-warranty on the authenticity of the submitted documents: which should include a list of the submitted documents, and commitment of the manufacturing enterprise on bearing legal liabilities. Requirements of Application Documents for Registration of Medical Devices from Abroad (1) Application form for registration of medical devices from abroad;
(2) Qualification certificate of the medical device manufacturing enterprise;
(3) A counterpart of the applicant's business license and a power of attorney issued by the manufacturing enterprise for the registration.
(4) Proof documents approved or accredited by the governmental medical device authority of the country (region) outside China on the products' entry as medical devices into the market of this country (region);
(5) Applicable product standards: If national standards or industry standards of China are adopted as the applicable standards for the products, the manufacturing enterprise shall submit the document on the adopted national standards or industry standards of China; standards for registered products shall be affixed with the stamp by the manufacturing enterprise or its representative office in China, or by an entity entrusted by the manufacturing enterprise to draft the standards. The power of attorney issued by the manufacturing enterprise for entrusting the drafting of standards shall indicate that "the manufacturing enterprise shall be responsible for the product quality". The manufacturing enterprise shall provide a declaration that the products under application meet the national standards or industry standards of China, a declaration that the manufacturing enterprise shall bear quality liabilities after the products have been on market, and a statement on defining the relevant product models and specifications. "Stamp" herein means either the organization stamp, or the signature of its legal representative or responsible person, or his signature plus the stamp (same as below where medical devices from abroad are involved);
(6) Medical device directions: The directions of medical devices on Categories II and III shall be affixed with the stamp by the manufacturing enterprise or its representative office in China, and no stamp needs to be affixed on the directions of medical devices on Category I;
(7) Product registration test report issued by the medical device testing institution: (applicable for medical devices on Categories II and III): With respect to the medical devices which need to be used for clinical trial, the manufacturing enterprise shall submit a testing report issued by a medical device testing institution within half a year prior to the beginning of the clinical trial. With respect to the medical devices which do not need to be used for clinical trial, the manufacturing enterprise shall submit a testing report issued by a medical device testing institution within 1 year prior to the acceptance of the application for registration. Where Article 11 , Article 12 , Article 13 or Article 14 of these Measures is applied, the applicant shall provide the corresponding documents of statement. When implementing Article 15 of these Measures, the manufacturing enterprise shall propose an application for temporarily postponing the test. The application shall guarantee that the registration test must be completed before the first set of product is put into use inside China;
(8) Documents on clinical trial of the medical devices (see Appendix 12 of these Measures for specific method of submission)
(9) Product quality guarantee letter issued by the manufacturing enterprise: which shall guarantee that the products registered in China for sale and use completely conform to the quality of the same products approved by the governmental medical device authority of the country (region) outside China to be on market;
(10) Power of attorney of the agent appointed by the manufacturing enterprise in China, the agent's commitment letter and its business license or institutional registration certificate: The contents undertaken by the agent in the commitment letter shall be consistent with the particulars in the power of attorney issued by the manufacturing enterprise. The agent shall also undertake in the commitment letter to be responsible for reporting ill medical device incidents, and be responsible for contacting the (food) drug administration;
(11) Power of attorney on appointing an after-sale service institution in China, the commitment letter and qualification certificate of the entrusted institution: The power of attorney for after-sale service shall be issued by the manufacturing enterprise, which shall state the product name, and in case of multi-level entrustment, the entrusting institution at each level shall provide the accreditation documents of the manufacturing enterprise. The contents undertaken by the after-sale service institution in the commitment letter shall be consistent with the particulars in the power of attorney. The qualification certificate of the after-sale service institution shall be its business license (whose business scope shall have the corresponding technical service items) or the registration certificate of the manufacturing enterprise's office in China.
(12) Declaration of self-warranty on the authenticity of the submitted documents: which shall be issued by the manufacturing enterprise or its representative office in China; the declaration shall contain a list of the documents submitted, including the commitment of bearing legal liabilities. All the above mentioned documents shall have their Chinese versions. The proof documents in Items (2) and (4) of this Appendix may be photocopies, provided that they must be affixed with the stamp by the original issuing organ or be notarized by the local public notarization institution; for other documents under this Appendix, unless otherwise prescribed in these Measures, the original copies affixed with the stamp of the manufacturing enterprise or its representative office in China shall be submitted. Requirements of Application Documents for Re-registration of Medical Devices from Abroad (1) Application form for registration of medical devices from the outside of China;
(2) Qualification certificate of the medical device manufacturing enterprise;
(3) The original medical device registration certificate: Under the circumstance in Article 33 of Chapter V of these Measures, the manufacturing enterprise shall submit a photocopy of the original medical device registration certificate; while under any of the circumstances in Article 34 or Article 35 of Chapter V of these Measures, it shall submit the original copy of the original medical device registration certificate.
(4) The proof document showing that the governmental medical device authority of the country (region) outside China approves or accredits the products to enter the country's (region's) market as medical devices.
(5) Applicable product standards and remarks: If national standards or industry standards of China are adopted as the applicable standards for the products, the manufacturing enterprise shall submit the document on the adopted national standards or industry standards of China; standards for registered products shall be affixed with the stamp by the manufacturing enterprise or its representative office in China, or by an entity entrusted by the manufacturing enterprise to draft the standards. The power of attorney issued by the manufacturing enterprise for entrusting the drafting of standards shall indicate that "the manufacturing enterprise shall be responsible for the product quality". The manufacturing enterprise shall provide a declaration that the products under application meet the national standards or industry standards of China, a declaration that the manufacturing enterprise shall bear quality liabilities after the products have been on market, and a statement on defining the relevant product models and specifications.
(6) Medical device directions: The directions of medical devices on Categories II and III shall be affixed with the stamp of the manufacturing enterprise or its representative office in China, and no stamp needs to be affixed on the directions of medical devices on Category I.
(7) Product registration test report issued by the medical device testing institution: (applicable for medical devices on Categories II and III): With respect to the medical devices which need to be used for clinical trial, the manufacturing enterprise shall submit a testing report issued by a medical device testing institution within half a year prior to the beginning of the clinical trial. With respect to the medical devices which do not need to be used for clinical trial, the manufacturing enterprise shall submit a testing report issued by a medical device testing institution within 1 year prior to the acceptance of the application for registration. Where Article 11 , Article 12 , Article 13 or Article 14 of these Measures is applied, the applicant shall provide the corresponding documents of statement. Where Item (2) of Article 10 of the "Provisions on Registration Test of Imported Medical Devices" is applied, the applicant shall provide the corresponding accreditation report.
(8) Follow-up report on product quality: The follow-up quality report issued by an agent of the manufacturing enterprise on the products which have been used in a medical institution in China shall include a statement on the ill medical device incident monitoring.
(9) Product quality guarantee letter issued by the manufacturing enterprise: which shall guarantee that the products registered in China for sale and use completely conform to the quality of the same products approved by the governmental medical device authority of the country (region) outside China to be on market.
(10) A power of attorney of the agent appointed by the manufacturing enterprise in China, the agent's commitment letter and its business license or institutional registration certificate: The contents undertaken by the agent in the commitment letter shall be consistent with the particulars in the power of attorney issued by the manufacturing enterprise. The agent shall also undertake in the commitment letter to be responsible for reporting ill medical device incidents, and be responsible for contacting the (food) drug administration.
(11) A power of attorney on appointing an after-sale service institution in China, the commitment letter and qualification certificate of the entrusted institution: The power of attorney for after-sale services shall be issued by the manufacturing enterprise, which shall state the product name, and in case of multi-level entrustment, the entrusting institution at each level shall provide the accreditation documents of the manufacturing enterprise. The contents undertaken by the after-sale service institution in the commitment letter shall be consistent with the particulars in the power of attorney. The qualification certificate of the after-sale service institution shall be its business license (whose business scope shall have the corresponding technical service items) or the registration certificate of the manufacturing enterprise's office in China.
(12) Under any of the circumstances in Article 34 of Chapter V of these Measures, the manufacturing enterprise shall submit a corresponding statement of the facts and the proof documents.
(13) Declaration of self-warranty on the authenticity of the submitted documents: which shall be issued by the manufacturing enterprise or its representative office in China; the declaration shall contain a list of the submitted documents, including commitment of bearing legal liabilities. All the above mentioned documents shall have their Chinese versions. The proof documents in Items (2) and (4) of this Appendix may be photocopies, provided that they must be affixed with the stamp by the original issuing organ or be notarized by the local public notarization institution; for other documents under this Appendix, unless otherwise prescribed in these Measures, the original copies affixed with the stamp of the manufacturing enterprise or its representative office in China shall be submitted. Requirements of Application Documents for Initial Registration of the Medical Devices on Category I from Abroad Which Have Not Been Permitted To Be on Market (1) Application form for registration of medical devices from abroad.
(2) Qualification certificate of the medical device manufacturing enterprise.
(3) Applicable product standards and remarks: If national standards or industry standards of China are adopted as the applicable standards for the products, the manufacturing enterprise shall submit the document on the adopted national standards or industry standards of China; standards for registered products shall be affixed with the stamp by the manufacturing enterprise or its representative office in China, or by an entity entrusted by the manufacturing enterprise to draft standards. The power of attorney issued by the manufacturing enterprise for entrusting the drafting of standards shall indicate that "the manufacturing enterprise shall be responsible for the product quality" The manufacturing enterprise shall provide a declaration that the products under application meet the national standards or industry standards of China, a declaration that the manufacturing enterprise shall bear quality liabilities after the products have been on market, and a statement on defining the relevant product models and specifications.
(4) Report on full performance test of the products.
(5) Statement on the existing resource conditions for the enterprise to produce products and on its quality management capacity (including testing method).
(6) Medical device directions (no need to be affixed with a stamp).
(7) A power of attorney of the agent appointed by the manufacturing enterprise in China, the agent's commitment letter and its business license or institutional registration certificate: The contents undertaken by the agent in the commitment letter shall be consistent with the particulars in the power of attorney issued by the manufacturing enterprise. The agent shall also undertake in the commitment letter to be responsible for reporting ill medical device incidents, and be responsible for contacting the (food) drug administration.
(8) A power of attorney on appointing an after-sale service institution in China, the commitment letter and qualification certificate of the entrusted institution: The power of attorney for after-sale services shall be issued by the manufacturing enterprise, which shall state the product name, and in case of multi-level entrustment, the entrusting institution at each level shall provide the accreditation documents of the manufacturing enterprise. The contents undertaken by the after-sale service institution in the commitment letter shall be consistent with the particulars in the power of attorney. The qualification certificate of the after-sale service institution shall be its business license (whose business scope shall have the corresponding technical service items) or the registration certificate of the manufacturing enterprise's office in China.
(9) Declaration of self-warranty on the authenticity of the submitted documents: which shall be issued by the manufacturing enterprise or its representative office in China; the declaration shall contain a list of the submitted documents, including commitment of bearing legal liabilities. All the above mentioned documents shall have their Chinese versions. The proof documents in Item (2) of this Appendix may be photocopies, provided that they must be affixed with the stamp by the original issuing organ or be notarized by the local public notarization institution; for other documents under this Appendix, unless otherwise prescribed in these Measures, the original copies affixed with the stamp of the manufacturing enterprise or its representative office in China shall be submitted. Requirements of Application Documents for Initial Registration of the Medical Devices on Categories II and III from Abroad Which Have Not Been Permitted To Be on Market (1) Application form for registration of medical devices from abroad.
(2) Qualification certificate of the medical device manufacturing enterprise.
(3) Product technical report: which shall include at least such contents as the technical index, or the basis for determining the main performance requirements.
(4) Security risk analysis report: which shall be compiled according to the standards of YY0316 "Medical Device Risk Analysis", and shall include the analysis in five respects, namely energy harm, biological harm, environmental harm, harm related to use and harm caused from invalidation, careless maintenance or ageing, and corresponding preventive measures, as well.
(5) Applicable product standards and remarks: If national standards or industry standards of China are adopted as the applicable standards for the products, the manufacturing enterprise shall submit the document on the adopted national standards or industry standards of China; standards for registered products shall be affixed with the stamp by the manufacturing enterprise or its representative office in China, or by an entity entrusted by the manufacturing enterprise to draft standards. The power of attorney issued by the manufacturing enterprise for entrusting the drafting of standards shall indicate that "the manufacturing enterprise shall be responsible for the product quality". The manufacturing enterprise shall provide a declaration that the products under application meet the national standards or industry standards of China, a declaration that the manufacturing enterprise shall bear quality liabilities after the products have been on market, and a statement on defining the relevant product models and specifications.
(6) Report on self-test of product performance: The items of self-test of product performance shall be the items of ex-factory test prescribed in the standards for registered products, which shall be signed by the principal tester, the responsible person for principal test, or the verifier. If national standards or industry standards are applied, the manufacturing enterprise shall supplement the items of ex-factory test determined by it.
(7) Product registration test report issued by the medical device testing institution: With respect to the medical devices which need to be used for clinical trial, the manufacturing enterprise shall submit a testing report issued by a medical device testing institution within half a year prior to the beginning of the clinical trial. With respect to the medical devices which do not need to be used for clinical trial, the manufacturing enterprise shall submit a testing report issued by a medical device testing institution within 1 year prior to the acceptance of the application for registration. Where Article 11 , Article 12 , Article 13 or Article 14 of these Measures is applied, the applicant shall provide the corresponding documents of statement.
(8) Documents on clinical trial of the medical devices (see Appendix 12 of these Measures for specific method of submission).
(9) Medical device directions (which shall be affixed with the stamp of the manufacturing enterprise or its representative office in China).
(10) Effective proof documents on product quality system assessment (certification): A production quality system assessment report issued by the State Food and Drug Administration regarding the medical devices under application for registration shall be submitted.
(11) A power of attorney of the agent appointed by the manufacturing enterprise in China, the agent's commitment letter and its business license or institutional registration certificate: The contents undertaken by the agent in the commitment letter shall be consistent with the particulars in the power of attorney issued by the manufacturing enterprise. The agent shall also undertake in the commitment letter to be responsible for reporting ill medical device incidents, and be responsible for contacting the (food) drug administration.
(12) A power of attorney on appointing an after-sale service institution in China, the commitment letter and qualification certificate of the entrusted institution: The power of attorney for after-sale services shall be issued by the manufacturing enterprise, which shall state the product name, and in case of multi-level entrustment, the entrusting institution at each level shall provide the accreditation documents of the manufacturing enterprise. The contents undertaken by the after-sale service institution in the commitment letter shall be consistent with the particulars in the power of attorney. The qualification certificate of the after-sale service institution shall be its business license (whose business scope shall have the corresponding technical service items) or the registration certificate of the manufacturing enterprise's office in China.
(13) Declaration of self-warranty on the authenticity of the submitted documents: which shall be issued by the manufacturing enterprise or its representative office in China; the declaration shall contain a list of the submitted documents, including commitment of bearing legal liabilities. All the above mentioned documents shall have their Chinese versions. The proof document in Item (2) of this Appendix may be a photocopy, provided that it must be affixed with the stamp by the original issuing organ or be notarized by the local public notarization institution; for other documents under this Appendix, unless otherwise prescribed in these Measures, the original copies affixed with the stamp of the manufacturing enterprise or its representative office in China shall be submitted. Requirements of Application Documents for Modification of a Medical Device Registration Certificate (I) Requirements of the application documents for modification of enterprise name: 1. the original copy of the medical device registration certificate (a photocopy shall be submitted at the time of application for modification, and the original copy shall be returned when the modified medical device registration certificate is obtained); 2. the new manufacturing enterprise permit (applicable for medical devices on Categories II and III inside China); 3. the new business license (applicable for medical devices inside China); 4. the manufacturing enterprise's new lawful qualification certificate (applicable for medical devices from abroad); 5. the new product standards (applicable for modified subject under the standards); 6. the manufacturing enterprise's statement on the modification and the relevant proof documents; 7. declaration of self-warranty on the authenticity of the submitted documents: which include a list of the submitted documents, and commitment of the manufacturing enterprise on bearing legal liabilities. If a registration certificate for medical devices from abroad is modified, the manufacturing enterprise or its representative office in China shall issue this declaration.
(II) Requirements of the application documents for literal change of product name, commodity name, product model, specifications, as well as literal change of the name or code of the product standards: 1. the original copy of the medical device registration certificate (a photocopy shall be submitted at the time of application for modification, and the original copy shall be returned when the modified medical device registration certificate is obtained); 2. the new product standards; 3. medical device directions; 4. the manufacturing enterprise's statement on the modification and the relevant proof documents; 5. declaration of self-warranty on the authenticity of the submitted documents: which include a list of the submitted documents, and commitment of the manufacturing enterprise on bearing legal liabilities. If a registration certificate for medical devices from abroad is modified, the manufacturing enterprise or its representative office in China shall issue this declaration.
(III) Requirements of the application documents for literal change of the manufacturing enterprise's registered address or modification of its production address: 1. the original copy of the medical device registration certificate (a photocopy shall be submitted at the time of application for modification, and the original copy shall be returned when the modified medical device registration certificate is obtained); 2. the new manufacturing enterprise permit (applicable for medical devices on Categories II and III inside China); 3. the new business license (applicable for medical devices inside China); 4. the manufacturing enterprise's statement on the modification and the relevant proof documents; 5. declaration of the manufacturing enterprise on modification of the address (applicable for medical devices from abroad); 6. declaration of self-warranty on the authenticity of the submitted documents: which include a list of the submitted documents, and commitment of the manufacturing enterprise on bearing legal liabilities. If a registration certificate for medical devices from abroad is modified, the manufacturing enterprise or its representative office in China shall issue this declaration.
(IV) Requirements of the application documents for modification of the agent in a medical device registration certificate issued outside China: 1. the original copy of the medical device registration certificate (a photocopy shall be submitted at the time of application for modification, and the original copy shall be returned when the modified medical device registration certificate is obtained); 2. a declaration issued by the manufacturing enterprise on modification of the agent; 3. a power of attorney issued by the manufacturing enterprise to the modified agent; 4. the business license or registration certificate of the modified agent; 5. commitments of the modified agent on accepting the entrustment and bearing the corresponding liabilities; 6. declaration of self-warranty on the authenticity of the submitted documents: which shall be issued by the manufacturing enterprise or its representative office in China; the declaration shall contain a list of the submitted documents, including commitment of bearing legal liabilities.
(V) Requirements on the application documents for modification of the after-sale service institution in the certificate for registration of medical devices from abroad: 1. the original copy of the medical device registration certificate (A photocopy shall be submitted at the time of application for modification, and the original copy shall be returned when the modified medical device registration certificate is obtained); 2. a declaration issued by the manufacturing enterprise on modifying or newly adding the after-sale service institution; 3. a power of attorney issued by the manufacturing enterprise to the modified or newly added after-sale service institution; 4. the manufacturing enterprise's treatment of and commitment on after-sale services for the sold products; 5. the business license or registration certificate of the modified or newly added after-sale service institution; 6. the commitment letter of the modified or newly added after-sale service institution on bearing after-sale service responsibilities; 7. declaration of self-warranty on the authenticity of the submitted documents: which shall be issued by the manufacturing enterprise or its representative office in China; the declaration shall contain a list of the submitted documents, including commitment of bearing legal liabilities. Requirements of Application Documents for Re-issuance of a Medical Device Registration Certificate (1) Reasons for re-issuance of the medical device registration certificate and statement of the facts.
(2) The applicant's qualification certificate;
(3) Photocopies of the medical device registration certificate and its appendices;
(4) Declaration of self-warranty on the authenticity of the submitted documents: which shall include a list of the submitted documents, and commitment of the manufacturing enterprise on bearing legal liabilities. If a registration certificate for medical devices from abroad is re-issued, the manufacturing enterprise or its representative office in China shall issue this declaration.
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