Since 2004, some foreign charity institutions in the name of donation have transferred medical devices, which are not in conformity with the State regulations, to China; they even have transferred medical wastes, which would bring serious threat to the people’s safety and health of China. In order to guarantee the safety and efficiency of imported medical devices, and protect the citizens’ health and safety, in accordance with the relevant laws and regulations of the State, relevant provisions on the imported donated medical devices are hereby promulgated as follows:
1. The donation of medical devices containing objects specified in the Catalog of Goods Prohibited from Import shall be prohibited.
The donated medical devices shall be new products, and have been registered as medical devices in China. Moreover, the donation cannot contain goods that would damage the environment, public health, social morality and political values.
2. For donated medical devices listed in The Catalogue of Automatic Import License of Mechanical and Electronic Products the imported entities shall apply for the Automatic Import License of the People’s Republic of China to the commercial administration department prior to customs declaration, and hold this license to proceed through customs clearance.
3. The AQSIQ shall undertake administration and archival filing of the donated medical devices prior to inspection. Overseas institutions donating medical devices to China shall, or through their agencies in China, apply to the AQSIQ to register the donated medical devices; and such medical devices donated by overseas institutions shall be recorded by the AQSIQ prior to inspection, and undergo the preliminary examination by the AQSIQ to be checked whether the archival filing materials are in conformity with provisions provided for in the Article 1 of the announcement. In addition, the AQSIQ shall organize and perform the pre-shipment inspection, if necessary. For commodities imported for special needs of the State, the Ministry of Civil Affairs and the AQSIQ shall give special treatment to them.
4. For imported donated medical devices (regardless whether or not they are listed in the Catalogue of Entry-exit Commodities to be Inspected and Quarantined by Entry-exit Inspection and Quarantine Institutions), the Customs shall undertake inspection on and clear them according to the Customs List of Commodities Entering into the Country issued by the inspection and quarantine institution in which the description of the above-mentioned “commodities are specified as donations” shall be clearly indicated. In the event that the commodities are subject to the management of import licenses, the Customs shall check their licenses prior to clearance.
5. The entities or their agencies that receive imported donated medical devices shall apply for importing inspection to the local inspection and quarantine institution. The inspection and quarantine institution relies on effective records to inspect the goods at the ports and at locations where the goods are in use.
For imported donated medical devices that have passed inspection and quarantine, the inspection and quarantine institution shall issue the Inspection and Quarantine Certificate for Commodities Entering into the Country, and only then the receiving entities (or individuals) may use the devices. However, imported donated medical devices that are unqualified shall be disposed in accordance with the relevant provisions provided for in the Law of the People's Republic of China on Import and Export Commodity Inspection and its regulations for the implementation, or be transferred to relevant Customs to be disposed in accordance with relevant regulations. The results of disposal shall be reported to the AQSIQ and China Customs as soon as possible.
6. Business Management Entities of civil organizations and registration authorities shall enhance the supervision and management of the civil organizations which accept the imported donations. For civil organizations accepting imported donations that are in violation of the relevant laws and regulations of the State, especially those involving malicious transfer of medical wastes to China shall be punished seriously till their registration is revoked.
7. This Announcement shall come into effect as of the date of promulgation.
General Administration of Quality Supervision, Inspection and Quarantine of the People’s Republic of China
Ministry of Commerce of the People’s Republic of China
Ministry of Civil Affairs of the People’s Republic of China
February 15th, 2006