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China Approves First Device through Marketing Authorization Holder Program, Green Lights Contract Manufacturing


China’s State Council announced a pilot program for medical device Marketing Authorization Holder (MAH) System at Shanghai free trade zone on Jan 5, 2018. On Feb 27, first approval through the program was granted.

The device, portable ECG recorder, is registered by Yuanxin Medtech and manufactured by MicroPort EP MedTech. It is intended for recording and displaying ECG data by adult patients who are concerned about their heart rhythm. It is classified as class II.

Shanghai CFDA office synchronized registration procedure and manufacture licensing system, to speed up the approval process for the ECG recorder. It only took 26 working days from acceptance to final approval. It has significant effect for the MAHs who have limited manufacturing capabilities that they can contract with a Contract Manufacturing Organization (CMO) with qualification to produce approved medical devices.

As of today, 20 enterprises have participated the program and 5 products have entered a priority approval channel. It is estimated that the approach will expand to provinces of Shanghai, Zhejiang and Jiangsu and then to the nationwide.


About China Med Device, LLC

China Med Device, LLC provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, post market compliance as well as legal agent representation. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have an office in Beijing, Suzhou and Boston. Our management team have 100+ years of combined experience in medical device and IVD and had been involved with 1,000+ CFDA certificates, 200+ western companies’ entry.

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