CFDA QMS Draft Guideline for Feedback: Incoming inspection, manufacturing process and finished goods

What does the sweeping changes of CFDA regulations mean to your medical devices in China?
September 23, 2016
Register for the Webinar! China Medical Device Regulatory Changes
January 24, 2017

CFDA QMS Draft Guideline for Feedback: Incoming inspection, manufacturing process and finished goods

I am sharing a response I posted to a question by a manufacturer RA.

The Guideline was issued on Sept 21 for further feedback and asked all feedback be emailed back by today. It was written in Chinese. Here is a snap shot of what the guideline is about. To understand the entire CFDA QMS, this is not the right forum.  If your corporate is interested in having a specific training associated with CFDA QMS, I would be more than happy to provide one for you.

Essentially the Guidelines you mentioned provide further details and explanations to the existing QMS regulations to make it more understandable and implemental. This guideline is specific to supply chain inspection, key mfg process verification and finished products release. It is based on the international standard ISO13485: 2016 “, the United States FDA” Quality System Standards and other International Medical Device Management Regulatory Quality Management System related documents and information.

Companies should take into account the regulatory, risk management, and technical specs requirements, as well as product characteristics, production scale, manufacturing process, quality management capabilities, etc to determine the best quality control path. It also emphasized the three key test/verification steps from design conversion to production ready products: 1) incoming inspection, 2) manufacturing process, 3) finished goods inspection.

In the example of 1) incoming inspection. The inspection procedures shall at least clearly identify the name, specification type, verification / confirmation / monitoring / measurement / inspection / test items and methods of the purchased goods, applicable equipment and apparatus, sampling plan, acceptance criteria, reference standard / reference measurement procedures and relevant Records and so on. The sampling plan should be statistically significant and the confidence in the statistical inference should in principle be no less than 95%.