Laws of the People's Republic of China

State Food and Drug Administration

Order of the State Food and Drug Administration

No. 15

The Measures for the Administration of License for Medical Appliance Operation Enterprises, which were deliberated and adopted at the executive meeting of the State Food and Drug Administration on June 25, 2004, are hereby promulgated and shall come into force as of the date of promulgation.

Director General, Zheng Xiaoyu

August 9, 2004

Measures for the Administration of License for Medical Appliance Operation Enterprises

Chapter I General Provisions

Article 1

The present Measures are formulated in accordance with the Regulation on the Supervision and Administration of Medical Devices for the purpose of strengthening the supervision and administration of the permission for medical appliance operation.

Article 2

The present Measures shall apply to the issuance, replacement, alteration, supervision and administration of the License for Medical Appliance Operation Enterprises.

Article 3

An enterprise that operates medical appliances of Class 2 or Class 3 shall hold the License for the Medical Appliance Operation Enterprise. However, an enterprise that operates certain small number of medical appliances of Class 2 and is able to guarantee the safety and efficacy of such medical appliances in the process of circulation through conventional management does not have to file an application for the License for the Medical Appliance Operation Enterprise. The List of the medical appliance products of Class 2 that do not require the License for Medical Appliance Operation Enterprises shall be formulated by the State Food and Drug Administration.

Article 4

The State Food and Drug Administration shall be in charge of the supervision and administration of the License for Medical Appliance Operation Enterprises within the country.

The administrative department of food/drug of all provinces, autonomous regions, and municipalities directly under the Central Government shall be in charge of the issuance, replacement, alteration, supervision and administration of the License for Medical Appliance Operation Enterprises within their own jurisdictions.

The food/drug administrative institutions at the municipal level or the food/drug administrative institutions at the county level directly established by the food/drug administrative department of all provinces, autonomous regions, or municipalities directly under the Central Government shall take charge of the daily supervision and administration of the License for Medical Appliance Operation Enterprises within their own jurisdiction.

Article 5

The State Food and Drug Administration shall gradually put in force regulations on medical appliance operation quality management. The criterion of the medical appliance operation quality management shall be formulated by the State Food and Drug Administration.

Chapter II Application conditions on the License for the Medical Appliance Operation Enterprise

Article 6

In order to apply for a License for the Medical Appliance Operation Enterprise, the applicant shall meet the following conditions concurrently:

(1)

It shall have a quality management department or full-time quality management personnel in accordance with its operational scale and business scope. The quality management personnel shall have State-accredited diplomas or professional title of relevant specialty;

(2)

It shall have a relatively independent business place in accordance with its operational scale and business scope;

(3)

Its storage conditions shall be suitable for its operational scale and business scope, including the storage facilities and equipment meeting the requirements of the medical appliance products' special features;

(4)

It shall establish and improve the product quality management systems, including the regulations on purchase, inspection and acceptance of purchased goods, warehousing custody, re-check upon leaving the warehouse, follow-up supervision of the quality and report of misconducts, etc.; and

(5)

It shall have the technical training and after-sale service capacities suitable for the medical appliance products it operates, or have reached an agreement with a third party that provide technical supports.

Article 7

An enterprise that applies for a License for the Medical Appliance Operation Enterprise must pass the examination conducted by the administrative department of food/drug.

In light of the actual situation of its own jurisdiction, the administrative departments of food/drug of all provinces, autonomous regions, or municipalities directly under the Central Government shall formulate the standards for inspection and acceptance of medical appliance operation enterprises, and submit such standards to the State Food and Drug Administration for archival filing in accordance with the present Measures.

Article 8

The business scope stated in a License for the Medical Appliance Operation Enterprise shall be determined according to the management class and classification code name prescribed in the catalogue of classification of medical appliances.

Chapter III Application procedures for the License of the Medical Appliance Operation Enterprise

Article 9

The administrative departments of food/drug of all provinces, autonomous regions, or municipalities directly under the Central Government or the entrusted food/drug administrative institution at the municipal level where the to-be-established enterprise is located or the entrusted shall take charge of processing the applications for the License of Medical Appliance Operation Enterprises.

Article 10

The administrative department of food/drug of the province, autonomous region, or municipality directly under the Central Government or the entrusted food/drug administrative institution at the municipal level shall announce the conditions, procedures, time limit, catalogue of all necessary materials to be submitted for applying for the License of the Medical Appliance Operation Enterprise, and a model text of the application letter as well on its administrative organ's website or at its location.

Article 11

When applying for the License for the Medical Appliance Operation Enterprise, the applicant shall submit the following documents:

(1)

The Application Form for the License of the Medical Appliance Operation Enterprise;

(2)

The testimonial issued by the administrative department for industry and commerce on pre-ratification of the enterprise's name;

(3)

The photocopies of the identity certificates, diplomas or professional title certificates and curriculum vitae of the quality management personnel of the enterprise to be established;

(4)

The organizational structure and functions of the enterprise to be established;

(5)

The sketch map of the location and the ichnography (indicated with acreage) of the registered address of the enterprise to be established, and those of the address of its warehouse, and a photocopy of premise ownership certificate (or lease agreement);

(6)

Documents on the product quality management system of the enterprise to be established, and a catalogue of its storage facilities and equipment; and

(7)

The business scope of the enterprise to be established.

Article 12

An applicant shall file the application for the License of the Medical Appliance Operation Enterprise to the administrative department of food/drug of the province, autonomous region, or municipality directly under the Central Government where the to-be-established enterprise is located, or to the entrusted food/drug administrative institution at the municipal level.

As to the application filed by an applicant for issuance of the license of the Medical Appliance Operation Enterprise, the administrative department of food/drug of the province, autonomous region, or municipality directly under the Central Government or the entrusted food/drug administrative institution at the municipal level shall deal separately according to the following circumstances:

(1)

If the application does not fall within the scope of powers of the abovementioned administration, a decision shall be made refusing to accept the application and the Notification on Not Accepting the Application shall be issued. The applicant shall be informed to file the application to other relevant department;

(2)

If the application materials contain any error that may be corrected on the spot, the applicant shall be allowed to correct the said error immediately;

(3)

If the application materials are incomplete or do not conform to the legal form, the abovementioned administration shall send a Notification for Supplement of Materials to the applicant, and inform the applicant of all the contents to be supplemented either on the spot or within 5 working days. If it fails to so inform the applicant, it shall be deemed as having accepted the application as of receipt of the application materials; or

(4)

If the application falls within the scope of powers of the abovementioned administration, and the application materials are complete and conform to the legal form, or all the supplemented application materials are submitted as required, the said administration shall issue the Notification on Accepting the Application, which shall be affixed with a special stamp for acceptance and be indicated with the date of acceptance.

Article 13

According to the standards for inspection and acceptance of medical device operation enterprises, the administrative department of food/drug of a province, autonomous region, or municipality directly under the Central Government or r entrusted food/drug administrative institutions at the municipal level shall make an on-site check on the enterprise to be established, and shall examine the application materials in accordance with the present Measures.

Article 14

The administrative department of food/drug of a province, autonomous region, or municipality directly under the Central Government shall make a decision on whether or not to ratify the issuance of the License for the Medical Appliance Operation Enterprise within 30 working days as of acceptance of an application. If it considers that the application meets the requirements, it shall make a decision on approving the issuance of the License for the Medical Appliance Operation Enterprise and issue the License for the Medical Appliance Operation Enterprise to the applicant within 10 days as of making the decision. However, if it considers that the application does not meet the requirements, it shall notify the applicant in writing form, stating the reason therefor and informing the applicant of the legal right to apply for administrative reconsideration or bring an administrative lawsuit.

Article 15

When examining the application filed by an applicant, the administrative department of food/drug shall announce the examination process and results. The applicant or an interested person may make its statement and defense by submitting written opinions regarding the matter directly related to its major interests.

Where an application for a License for the Medical Appliance Operation Enterprise directly involves the major interest relationship with the applicant or others, the administrative department of food/drug shall inform the applicant or the said other related person of the legal right to apply for a hearing.

Where a administrative department of food/drug considers that a License for the Medical Appliance Operation Enterprise involves public benefits, it shall make an announcement to the public and hold a hearing.

Article 16

The administrative department of food/drug of a province, autonomous region, or municipality directly under the Central Government shall publish the relevant information on the issued License for Medical Appliance Operation Enterprises, and the right to inquire about such information remains with the public.

Chapter IV Alteration and Replacement Issuance of License for Medical Appliance Operation Enterprises

Article 17

The alteration of items in a License for the Medical Appliance Operation Enterprise may be divided into alteration of permitted contents and alteration of registered contents.

The alteration of permitted contents shall include alteration of the quality management personnel, the registered address, the business scope, and the address of the warehouse (including adding or removal of a warehouse).

The alteration of registered contents shall mean the alteration of the contents other than those mentioned above.

Article 18

With a view to modifying a permitted content in a License for the Medical Appliance Operation Enterprise, the medical appliance operation enterprise shall fill out the application letter for alteration of the License for the Medical Appliance Operation Enterprise, and submit the photocopies of the Business License and the License for the Medical Appliance Operation Enterprise, which shall be affixed with its stamp.

With a view to modifying the quality management personnel, the said enterprise shall meanwhile submit the photocopies of the identity certificates of the newly appointed quality management personnel, their diplomas or professional title certificates; with a view to modifying the registered address, the said enterprise shall meanwhile submit a photocopy of the ownership certificate of the modified address or of the lease agreement, a sketch map of the location, an ichnography and a statement on storage conditions; with a view to modifying the business scope, the said enterprise shall meanwhile submit a photocopy of the registration certificate for the product under planned operation, and a statement on the corresponding storage conditions, as well; with a view to modifying the address of the warehouse, the said enterprise shall meanwhile submit a photocopy of the ownership certificate of the modified address of the warehouse or of the lease agreement, a sketch map of the location, an ichnography and a statement on storage conditions.

Article 19

Where a medical appliance operation enterprise applies for alteration of a permitted content, the administrative department of food/drug of the province, autonomous region, or municipality directly under the Central Government or the entrusted food/drug administrative institution at the municipal level shall examine the application according to the standards for inspection and acceptance of medical device operation enterprises within 15 working days as of acceptance of the medical device operation enterprise's application for alteration of the permitted content, and the administrative department of food/drug of the province, autonomous region, or municipality directly under the Central Government shall make a decision on whether or not to approve the alteration; if an on-site inspection is needed, the said administration shall make a decision on approving or not approving the alteration within 20 working days as of acceptance of the application.

Where the administrative department of food/drug of a province, autonomous region, or municipality directly under the Central Government makes a decision on approving the alteration, it shall record the modified content and the time of alteration on the counterpart of the License for the Medical Appliance Operation Enterprise; however, if it does not approve the alteration, it shall inform the applicant in writing form stating the reason therefor and informing the applicant of the legal right to apply for administrative reconsideration or bring an administrative lawsuit.

After alteration of a permitted content of the License for the Medical Appliance Operation Enterprise, a medical appliance operation enterprise shall legally go through the relevant alteration procedures of enterprise registration in the administrative department for industry and commerce. The valid term of the modified License for the Medical Appliance Operation Enterprise shall remain unchanged.

Article 20

Where a medical appliance operation enterprise's operation in violation of law has been put on the file by the administrative department of food/drug for investigation, but the case is not finalized; or the enterprise received an administrative penalty decision, but has not implemented the penalty, the administrative department of food/drug of the province, autonomous region, or municipality directly under the Central Government or the entrusted food/drug administrative institution at the municipal level shall suspend accepting or examining the enterprise's application for alteration of the permitted content in the License for the Medical Appliance Operation Enterprise until the case is finalized.

Article 21

Where a medical appliance operation enterprise intends to have a registered content in the License for the Medical Appliance Operation Enterprise modified, it shall fill out the application letter for alteration of the License for the Medical Appliance Operation Enterprise within 30 days after the administrative department for industry and commerce approves the alteration, and apply to the administrative department of food/drug of the province, autonomous region, or municipality directly under the Central Government or the entrusted food/drug administrative institution at the municipal level for alteration registration of the License for the Medical Appliance Operation Enterprise. The administrative department of food/drug of the province, autonomous region, or municipality directly under the Central Government or the entrusted food/drug administrative institution at the municipal level shall, handle the alteration formalities, and notify the applicant within 15 working days as of receipt of the application for alteration.

Article 22

After alteration of a registered content in the License for the Medical Appliance Operation Enterprise, the administrative department of food/drug of the province, autonomous region, or municipality directly under the Central Government or the entrusted food/drug administrative institution at the municipal level shall record the modified contents and time of alteration on the counterpart of the License for the Medical Appliance Operation Enterprise. The valid term of the modified License for the Medical Appliance Operation Enterprise shall remain unchanged.

Article 23

Where an enterprise is divided, merged, or moved to another jurisdiction, it shall re-apply for a License for the Medical Appliance Operation Enterprise in accordance with the present Measures.

Article 24

The valid term of the License for a Medical Appliance Operation Enterprise shall be 5 years. At expiry of the valid term, if the medical appliance operation enterprise needs to continue to operate the medical appliance products, it shall apply to the administrative department of food/drug of the province, autonomous region, or municipality directly under the Central Government or the entrusted food/drug administrative institution at the municipal level for replacement issuance of the License for the Medical Appliance Operation Enterprise 6 months prior to the expiry of the valid term,.

The administrative department of food/drug of the province, autonomous region, or municipality directly under the Central Government or the entrusted food/drug administrative institution at the municipal level shall examine the application for replacement issuance of the license in accordance with the present Measures.

The administrative department of food/drug of the province, autonomous region, or municipality directly under the Central Government shall make a decision on whether or not to approve the replacement of the license prior to the expiry of valid term of the License for the Medical Appliance Operation Enterprise,. If it fails to make the decision within the time limit, it shall be deemed as consenting to the replacement of the license and shall handle the corresponding formalities.

Where the administrative department of food/drug of the province, autonomous region, or municipality directly under the Central Government considers that the application meets the requirements, it shall issue a new License for the Medical Appliance Operation Enterprise and take back the former one at expiry of the License for the Medical Appliance Operation Enterprise; however, if, the application does not meet the conditions, it shall order the applicant to make a rectification within a time limit; if the applicant still fails to meet the conditions after rectification, the said administrative department shall nullify the former License for the Medical Appliance Operation Enterprise at expiry of the valid term, inform the applicant in writing form, stating the reason therefor and informing the applicant of the legal right to apply for administrative reconsideration or bring an administrative lawsuit.

Article 25

Where a medical device operation enterprise loses its License for the Medical Appliance Operation Enterprise, it shall immediately report to the administrative department, of food/drug and make an announcement of the loss on a media designated by the administrative department of food/drug of the province, autonomous region, or municipality directly under the Central Government. The administrative department of food/drug of the province, autonomous region, or municipality directly under the Central Government shall re-issue the License for the Medical Appliance Operation Enterprise on the basis of the original approved contents after 1 month as of the enterprise's publishing of the statement of loss. The valid term of the re-issued License for the Medical Appliance Operation Enterprise shall be the same as that of the former License for the Medical Appliance Operation Enterprise.

Chapter V Supervisory Inspections

Article 26

A administrative department of food/drug at the higher level shall strengthen its supervisory inspections on the granting of medical appliance operation permits by the administrative departments of food/drug at the lower levels, and shall timely correct the illegal acts in granting administrative permits.

Article 27

A administrative department of food/drug shall set up the working archives on issuance, replacement, alteration, supervisory inspection, etc. of the License for Medical Appliance Operation Enterprises, and shall report the information of the last quarter on issuance, replacement, alteration, supervisory inspection, etc. of the License for Medical Appliance Operation Enterprises to the administrative department of food/drug at the next higher level in the first of week of each quarter. As to the legally invalidated or recovered License for Medical Appliance Operation Enterprises, the administrative department of food/drug of the province, autonomous region, or municipality directly under the Central Government shall set up an archive and keep it for 5 years.

Article 28

A administrative department of food/drug shall strengthen its supervisory inspections on medical device operation enterprises. The main contents of supervisory inspection shall include:

(1)

Name of the enterprise, change of the enterprise's legal representative, person-in-charge and quality management personnel;

(2)

Change of the enterprise's registered address and address of the warehouse;

(3)

Information on the business place, storage conditions and main storage facilities and equipment;

(4)

Implementation and change of the business scope and other important contents;

(5)

Implementation of the enterprise product quality management system; and

(6)

Other relevant contents to be inspected.

Article 29

A supervisory inspection may be conducted in the way of written inspection, on-site inspection, or combining the written inspection with the on-site one. If a medical appliance operation enterprise is under any of the following circumstances, the administrative department of food/drug must conduct an on-site inspection:

(1)

It is an enterprise newly established in the last year;

(2)

It has problems in the inspection of the last year;

(3)

It is an enterprise subject to any administrative penalty due to violation of any relevant law or regulation; or

(4)

Any other case where the food/drug administrative department considers an on-site inspection should be conducted.

Article 30

In the year when the License for the Medical Appliance Operation Enterprise is replaced, the supervisory inspection and the replacement examination may be conducted simultaneously.

Article 31

When legally conducting a supervisory inspection on a medical appliance operation enterprise, a administrative department of food/drug shall record the information on the supervisory inspection and the results, which shall be signed by the supervisory inspectors and then be kept in archives. The administrative department of food/drug shall announce the on-site inspection results and record them on the counterpart of the License for the Medical Appliance Operation Enterprise.

Article 32

In case any of the following circumstances arises, the License for the Medical Appliance Operation Enterprise shall be nullified by the original administrative department that issued the license:

(1)

The valid term of the License for the Medical Appliance Operation Enterprise has expired and the enterprise fails to apply for replacement issuance or is not approved for a new license ;

(2)

The medical appliance operation enterprise terminates its business or is legally closed up;

(3)

The License for the Medical Appliance Operation Enterprise is legally cancelled, withdrawn, revoked, recovered or invalidated;

(4)

The medical appliance operation enterprise is unable to carry out its normal business due to force majeure; or

(5)

Other circumstances under which the License for the Medical Appliance Operation Enterprise is required to be nullified by any law or regulation.

Where a administrative department of food/drug nullifies the License for the Medical Appliance Operation Enterprise, it shall notify the administrative department for industry and commerce and announce the nullification to the public within 5 working days as of the nullification,.

Chapter VI Legal Liabilities

Article 33

Where a medical appliance operation enterprise unlawfully modifies any of its quality management personnel, it shall be ordered by the administrative department of food/drug to make a correction within the time limit. If it fails to make a correction within the time limit, it shall be fined 5,000 Yuan up to 10,000 Yuan.

Article 34

Where a medical appliance operation enterprise unlawfully modifies its registered address or address of the warehouse, it shall be ordered by the administrative department of food/drug to make a correction within the time limit, imposed upon a circularized criticism, and fined 5,000 Yuan up to 20,000 Yuan in addition.

Article 35

Where a medical appliance operation enterprise unlawfully enlarges its business scope or lowers its operational conditions, it shall be ordered by the food/drug administrative department to make a correction within the time limit, imposed upon a circularized criticism, be fined 10,000 Yuan up to 20,000 Yuan in addition.

Article 36

Where an applicant conceals the relevant information or provides false materials to apply for the License for the Medical Appliance Operation Enterprise, the administrative department of food/drug of the province, autonomous region, or municipality directly under the Central Government or the entrusted food/drug administrative institution at the municipal level shall refuse to accept the application or refuse to ratify the issuance of the License for the Medical Appliance Operation Enterprise, and shall warn the application in addition. The applicant may not apply for the License for the Medical Appliance Operation Enterprise again within 1 year.

Article 37

Where an applicant obtains the License for the Medical Appliance Operation Enterprise by fraud, by offering bribery, or by other foul means, the administrative department of food/drug shall revoke its License for the Medical Appliance Operation Enterprise, warn it, and fine it 10,000 Yuan up to 20,000 Yuan. The said applicant may not apply for the License for the Medical Appliance Operation Enterprise again within 3 years.

Article 38

Where a medical appliance operation enterprise has any of the following acts, it shall be ordered by the administrative department of food/drug to make a correction within the time limit, and be warned; if it refuses to make a correction within the time limit, it shall be fined 10,000 Yuan up to 20,000 Yuan:

(1)

Altering, buying and selling for profit, leasing, or lending the license for the Medical Appliance Operation Enterprise, or illegally assigning the License for the Medical Appliance Operation Enterprise in any other form;

(2)

Carrying out business activities out of the business scope stated in the License for the Medical Appliance Operation Enterprise; or

(3)

Concealing the relevant information or providing false materials in supervisory inspection, or refusing to provide authentic materials reflecting its business situation.

Article 39

Where an enterprise violates any relevant law or regulation under any other circumstance, in the issuance, replacement issuance, alteration, supervision and administration of the License for the Medical Appliance Operation Enterprise, it shall be punished in accordance with the relevant laws and regulations.

Chapter VII Supplementary Provisions

Article 40

The License for a Medical Appliance Operation Enterprise shall include the original copy and the counterpart. Both the original copy and the counterpart of the License for the Medical Appliance Operation Enterprise shall have equal legal binding force. The original copy of the License for the Medical Appliance Operation Enterprise shall be placed at an eye-catching position of the medical appliance operation enterprise's operation place.

The License for a Medical Appliance Operation Enterprise shall state the enterprise's name and legal person, the names of the person-in-charge and the quality management personnel, the business scope, the registered address, the address of the warehouse, the license number, the serial number of the license, the administrative department that issued the license, the date of issuance and the valid term, etc.

Article 41

The License for Medical Appliance Operation Enterprises shall be uniformly printed by the State Food and Drug Administration. The specimens of the original copies and counterparts of the License for Medical Appliance Operation Enterprises and the numbering method shall be uniformly formulated by the State Food and Drug Administration.

Article 42

The present Measures shall come into force as of the date of promulgation. The Measures for the Supervision and Administration of Medical Appliance Operation Enterprises promulgated by the State Drug Administration by Order No. 19 shall be abolished simultaneously.