On September 11th, 2017, Beijing provincial CFDA announced a notice of “Strengthen the Supervision and Inspection of Import Medical Device Distributors”.
1. Objectives:
· Understand the operation quality control status of current import medical device distributors in Beijing.
· Improve medical device operation quality control standards
2. Inspection scope
Import medical device general agents and regional distributors that have imported medical devices directly from oversea manufacturers and have obtained certificates complying with “Medical Device Operation License” or “Class II Medical Device Operation Filing Notification”.
3. Responsibilities of the Bureau
a. Supervision and Inspection
1) Legal qualification
2) Warehouse and transportation management
3) Product identification management
4) Quality traceability
b. Cross Inspection
c. Flight Inspection
d. Retrospective system
e. Summary report
4. Requirements
a. All the district bureaus should start risk investigation. They should combine the risk information with practical supervision information to find out the “hidden rules” in the industry
b. For agents that have illegal acts, Beijing CFDA should give sanctions. For agents with severe violations, Beijing CFDA should suspend their licenses. For agents with criminal acts, Beijing CFDA should pass the case to the policy department.
c. All the district bureaus should communicate with each other. Beijing CFDA is responsible for coordinating cross inspection and cases. Smuggling, refurbishing equipment and other major illegal events should be reported to Beijing CFDA.
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