On 13.05.2020, the NMPA (National Medical Products Administration) published a notice (No.46-2020) with further details on the recently implemented medical device sampling inspection requirements. It addresses the important work items for inspection, reinspection, objections and appeals, and other requirements based on the administrative measures (No.09-2020) released on 13th March. A high level summary of the measures is set out below.
Inspection
All provincial MPAs (Medical Product Administration) and the National Institutes for Food and Drug Control should refer to detailed requirements set out behind Annex 1 and Annex 2 of the Notice for conducting sampling inspections on medical devices in China. Both of the Annexes outline the specific regulatory standards, inspection items, and principles for determining the inspection results.
Reinspection
According to Rule 32 in the NMPA’s administrative measures (No.09-2020) for sampling inspection on medical devices, an application for an appeal reinspection can be made by the NMPA Legal Agent who is dissatisfied with the results of the inspection report. Such application must be made within 7 working days following the day on which the inspection report was received.
Objections & appeals
The application for an appeal reinspection must be submitted to the corresponding provincial MPA, in written form and should include any materials as proof, within 7 working days following the day on which the inspection report was received.
The respective provincial MPA should file a report within 2 working days following the day on which the application was received. The National Institutes for Food and Drug Control should receive a revalidation of the inspection results and suggestions from the local MPA within 15 working days.
Other requirements
According to Rule 30 in the NMPA’s administrative measures (No.09-2020) for sampling inspection on medical devices, if the NMPA Legal Agent claims that the sample product is not the same original product, the NMPA Legal Agent must submit any related materials to the respective local MPA as proof.
Also, the NMPA Legal Agent must submit the materials within 7 working days following the day on which the inspection report was received.
Read more from our prior news about the NMPA‘s administrative measures (No.09-2020) for sampling inspection on medical devices.
By Jacky Li. Contact Cisema to learn more.
