Comments on the NMPA's Public Consultation on the National Medical Device Quality Sampling Inspection Work Procedure (Draft for Comments)

2020-11-12 | Beijing

On 12th November, the medical device sector submitted comments on the National Medical Device Quality Sampling Inspection Work Procedure (Draft for Comments) to the National Medical Products Administration, focusing on:

1. It is recommended to reduce repetitive inspections such as national and provincial sampling. For companies that have passed the sampling for several consecutive years, it is recommended that they be exempt from sampling or inspection.
2. For products with unqualified sampling results, it is recommended not to stop production or recall procedures across the board, but to make decisions based on the results of risk control.
3. It is recommended to clarify the sample acquisition method in the sampling procedure.