Working Procedures for Medical Device Quality Spot Inspections in China

On April 13, the NMPA (National Medical Products Administration) published (No.46-2021) the working procedures for medical device quality spot inspections in China.

In accordance with the NMPA’s administrative measures (No.9-2020) for sampling inspection on medical devices, the working procedures consists of 20 pages addressing the details for the following items whilst 29 pages are appendices.

Development of the quality spot inspection plan by the China government

Role and responsibilities of the parties involved to carry out the quality spot inspections

Inspection work procedure

Re-inspection

Inspection report and results (Paper / Electronic Certificates)

Objections and appeals against inspection results

Compilation of the inspection results into quality analysis reports

Follow up work for failed inspections and using inspection reports as statutory evidence for administrative penalties

The announcement focuses on the standard working procedure of quality spot inspection to identify the possible risks of product safety. The inspection takes place in China, but it may occur to both domestic and overseas medical devices. The submission of quality analysis report will be required if necessary whilst post-market activities will also be involved.

By Jacky Li. Contact Cisema if you would like to learn more.