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China Eliminates Redundant Regulatory Processes
The two Chinese government departments responsible for registering medical devices have jointly announced that the existing redundant testing and factory inspection requirements for product registration have been eliminated.
Specifically, the China State Food and Drug Administration will accept the CCC factory inspection conducted by the Agency for Quality Supervision, Inspection and Quarantine for compulsory product certification (also known as the “CCC Mark”) as the quality system audit report for medical device product registration applications. Additionally, the two departments stated that only one product test will be conducted, which will meet the requirements of both agencies; one test report will be issued; and one fee will be charged.
Until now, products that require AQSIQ compulsory product certification (certain products with electrical components*) had to go through two sets of product testing and factory inspections, which has been time-consuming and expensive. Our research showed that the tests and inspections were virtually identical. AdvaMed has been working with the U.S. and Chinese Governments, along with the American Chamber of Commerce in China, to try to eliminate this duplication for close to four years. The US-China Joint Commission on Commerce and Trade took on the issue two years ago and raised it to the State Council for discussion, which was key to its resolution.
(* These products include: Medical X-ray diagnostic equipment, hemodialysis equipment, hollow-fiber dialyzers, extracorporeal blood circuit for blood purification equipment, electrocardiographs, pacemakers, artificial heart-lung machines and rubber condoms. )
Read China’s announcement (English translation).
For additional information, members can contact AdvaMed’s Nancy Travis.
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