Interpreting China Medical Device regulations/standards


I am working on a project to do gap assessments for my company on some Chinese regulations/standards and I am having difficulty interpreting them. There are a few mentions of the employer keeping medical records and/or immunization records for employees who work on the manufacturing line but that would be a big HIPAA issue, not to mention privacy.

There are many more that I am also having trouble with and I was wondering if anyone had a good resource or tool that could help link the regulations to CFR820 or ISO13485. Any input would be appreciated.


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I can tell you from working experience with NMPA that there is a good measure of similarity between CFR 820, ISO 13485 and NMPA regulation but there is no real good recourse or tool for doing a gap analysis at a lower level.
You will need to hook up with a local RA/QA agency to help you with that.

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