NMPA Further Clarifies Sampling Inspection Procedures for Medical Devices (Draft Amendment)

On October 13, the NMPA (National Medical Products Administration) issued the draft document to improve the work efficiency of sampling inspection procedures and minimize processing times.

What’s new in the proposed regulation?

• The inspection facilities’ application process and requirements
• Workflow to ensure the newly designed checklist form has been completed before the inspection
• The procedure to confirm the samples before the inspection will be removed

The NMPA has made announcements on March 10, 2020 (No.9-2020) and May 13, 2020 (No.46-2020), which served as a key basis to the development of the draft proposal. Read our previous articles about both announcements (No.9-2020 & No.46-2020).

NMPA Legal Agents will play a more important role when the document is finalized, due to their increased involvement in the sampling process and post-market surveillance requirements generally.

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