Laws of the People's Republic of China

General Administration of Quality Supervision, Inspection and Quarantine, General Administration of Customs, Ministry of Commerce and Ministry

GAQSIQ, GAC, MOFCOM and MCA Announcement No.17, 2006, Announcement on Strengthening Supervision and Administration on Import of Donated Medical Appliances

[2006] No.17

Since 2004, some foreign charities have been transferring inferior medical appliances, or even medical junks to China in name of donations, resulting in serious potential safety hazard. For purposes of ensuring security and effectiveness of imported medical appliances and safeguarding health and life safety of Chinese citizens, related regulations on importing donated medical appliances are now announced in accordance with related laws and regulations.

1.

Foreign donators are forbidden from secretly carrying commodities listed in List of Commodities Forbidden to Be Imported when donating medical appliances to China.

The donated medical appliances must be new and registered in China. Prohibited articles that are harmful to environment, public sanitation and social standards as well as contrabands of political pervasion are strictly forbidden.

2.

When importing donated medical appliances listed in List of Electromechanical Products with Automatic Import Permission, importers should apply for Automatic Import License of the People's Republic of China to administrative commercial departments before going through formalities of declaration.

3.

General Administration of Quality Supervision, Inspection and Quarantine will record the import of donated medical appliances before inspection. All foreign charities or their agencies in china shall apply for registration to General Administration of Quality Supervision, Inspection and Quarantine in case of intending to donate medical appliances to China. Donated medical appliances should be registered before inspection; General Administration of Quality Supervision, Inspection and Quarantine will carry out preliminary examination on materials of registration in accordance with Article 1 of this Announcement. In case of necessity, General Administration of Quality Supervision, Inspection and Quarantine will organize preliminary inspection before the shipment; in case of particularity, Ministry of Civil Affairs will carry out special treatment after consultation with General Administration of Quality Supervision, Inspection and Quarantine.

4.

Customs will examine and approve the import of donated medical appliances (no matter they are listed in the List of Entry-Exit Commodity of Inspection and Quarantine or not) based on Declared From of Imported Commodity with words of "donated articles" issued by institutes of inspection and quarantine; as regards those related to import license administration, Customs will check import licenses in addition.

5.

The receivers of donated medical appliances or their agencies must apply for import inspection to institutes of inspection and quarantine, which will accept declaration of examination and carry out inspection on ports as well as sites where the medical appliances are used based on effective materials of registration.

Receivers can only use eligible donated medical appliances with Certification of Inspection and Quarantine of Commodities of Entry released by institutes of inspection and quarantine. The inferior medical appliances should either be treated in accordance with related laws and regulations, or transferred to related Customs for disposal; the results of disposal should be reported to General Administration of Quality Supervision, Inspection and Quarantine and General Administration of Customs as soon as possible.

6.

Administrative units of non-governmental organizations and administrative organs of registration shall enhance supervision and administration on non-governmental organizations that receive the donations. Non-governmental organizations that receive illegal donations, especially those spitefully transfer medical junks to China will be severely punished and even their registrations will be cancelled.

7.

This Announcement takes effect as from release.

General Administration of Quality Supervision, Inspection and Quarantine

General Administration of Customs

Ministry of Commerce

Ministry of Civil Affairs

Feb 15, 2006