Recently, the US AGAPE Foundation has repeatedly transferred unqualified medical instruments, even medical wastes, to China in the name of donation. It would pose potential dangers to the safety and health. In order to guarantee the safety and effectiveness of imported medical instruments and safeguard people’s health and security, this Announcement is hereby promulgated as follows:
1. Any institution shall not be allowed to transfer unqualified medical devices into China in the name of donation.
2. The export of medical devices by the US AGAPE Foundation to China shall be ceased as of today.
3. Local inspection and quarantine institutions throughout the country shall enhance the inspection and supervision administration over donated medical devices. In case any unqualified is detected, the corresponding installation and use shall be forbidden. Moreover, such donated medical devices shall be dealt with in accordance with relevant laws and regulations, and be reported to the AQSIQ.
4. For donating medical devices to China, the overseas institution which donates such devices or its agency in China shall apply to the AQSIQ for archival filing; such donated medical devices shall also be reported to the AQSIQ for applying for registration and archival filing.
5.The donated medical devices shall be submitted for inspection to accept on port inspection, using place inspection and pre-shipment inspection if necessary, based on the record-keeping and registration certificate.
November 4th, 2005