On September 18th, Beijing CFDA issued “Guideline for IVD Production Quality System Key Inspection Areas (Draft)” for comments. This guideline is the revised version for “Guideline for IVD Production Quality System Key Inspection Areas (2003)”. It aims at improving the medical device inspection staffs’ understanding of medical device production key processes and help them to implement the supervision and inspection work.
Here are the key covered areas:
- Staff Management Requirements
- Production Environment, Facilities and Equipment Control Requirements
- Material Purchasing Control Requirements
- Production Process Control Requirements
- Product Testing and Quality Control Requirements
If you want to know the details of above 5 key areas, please contact us at email@example.com or call at 978-390-4453.
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