Dear manufacturer
who has products approved in China, it is only 3 weeks left till you have to submit your annual quality management report per chinese agent.
We got a lot of complaints from clients:
- distributor as Chinese agent has no QM knowledge to support report.
- a bad translated QM report with misunderstanding term
- no clear instruction how to fill the template
- untactic communication bw Chinese partners and internal groups
Ask us here or via email any questions. We highlight this new obligation of annual QM report in an article:
Chinese annual quality management report (easychinapprov.com)
Actually there are only 8 capitals for overseas manufacturer in main template and 8 annexes:
- Basic info
- Change assessment
- Post market surveillance
- Adverse event and PRER
- Sample inspection
- Centralized procurement
- Punishment in China
- Internal audit and management review
It is less complex than you thought...
We look forward to authorities new post market requirements. PMCF might follow...
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CEO
Antonio Lee
EasyChinapprov
(China and global registration)
Germany, China
info@easychinapprov.com------------------------------