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Beijing CFDA Issued “Guideline for IVD Production Quality System Key Inspection Areas (Draft)” for Comments


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:

  1. Staff Management Requirements
  2. Production Environment, Facilities and Equipment Control Requirements
  3. Material Purchasing Control Requirements
  4. Production Process Control Requirements
  5. Product Testing and Quality Control Requirements

If you want to know the details of above 5 key areas, please contact us at or call at 978-390-4453.


About China Med Device, LLC (CMD) CMD provides turn-key solution for Western medtech companies with regulatory and commercialization services. CMD helps its clients accelerate China entry and growth by offering: market Intelligence and research; CFDA regulatory services (premarket submission, clinical evaluation, clinical trial design & management, post market compliance and legal representation), and other commercial services. If you have an inquiry or feedback regarding our services please email us at

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