The last time the SDA (CFDA) "Medical Device Supervision and Management Regulations" were completely overhauled was in 2014 with a supplemental update in 2017. Today (June 25th, 2018) the new draft regulations are going through historical changes focusing on expediting innovation and achieving much needed reform. It is timely in that U.S. tariffs are anticipated to be levied at 25% duty on many of the medical devices shipped from China to the U.S.
Articles impacted: 12 articles newly added, 2 deleted and 39 modified.
Major changes:
- Perfecting medical device registration holder system. The registration holder can now be independent of the manufacturer.
- Relaxed the requirements for CER and clinical trials and acceptance of overseas clinical trial data. Added conditional approval to expedite certain devices entry.
- Class II domestic devices approval has been moved from provincial SDA (CFDA) to the national one. Provincial and local SDA (CFDA) will establish career inspectors like the regional FDA inspectors in the U.S.
- Type testing and 3rd party reviews are being encouraged.
Please email Info@ChinaMedDevice.com if you would like to schedule a consultation about these transformational changes from the SDA (CFDA).
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, QA and post market compliance. We are experienced in handling innovation approvals and priority reviews. Our commercial services cover market assessment research, reimbursement, partnership, distribution qualification and management. We have offices in Beijing, Suzhou and Boston. Our management team has 100+ years of combined experience in medical device and IVD and has been involved with 1,000+ CFDA certificates and 200+ companies' success.
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Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com978-390-4453
www.chinameddevice.com------------------------------