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It’s Official: CFDA Innovation Approval Guideline Effective Dec 1, 2018


On November 5, 2018, NMPA (CFDA) published final guideline “Special Review and Approval Procedure for Innovative Medical Devices” per CFDA notice No.13 2014. The guideline focuses on establishing a gradation administration and facilitating the approval process. The guideline states that this new rule is coming into force on December 1, 2018.

Summary of CFDA Innovation Approval Guideline

With the purpose of encouraging innovations and seeking breakthroughs of the medical device industry, this CFDA Innovation Approval Guideline has paved a fast track for regulatory clearance on eligible foreign medical devices. In addition, the granted priority manifests in the classification determination, pre-clinical testing, QMS auditing, and CFDA reviewing/approving processes. Meanwhile, a specially-assigned CFDA officer would check in and provide guidance throughout the whole expedite process.

Qualification For the Special Review and Approval Procedure

The CFDA Innovation Approval Guideline further states that your medical device and IVD product must meet all of the following criteria to qualify for the special review and approval procedure:

  • Class II / Class III Medical Device with significant clinical application value,
  • Own valid invention patents,
  • Have China PTO coverage,
  • Complete the preliminary study on prototype with traceable data, and
  • An authorized in-country legal entity.


For English version of the guideline, please email

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About China Med Device, LLC

China Med Device, LLC (CMD) provides turn-key solutions for western medical device/IVD companies to enter China with regulation and commercialization services. Specifically, our CFDA regulatory services cover strategy, premarket submission, clinical evaluation, CRO, QA, post market compliance. The CMD team is experienced in handling innovation approval with CFDA. Our commercial services cover market assessment research, reimbursement, partnership, as well as distribution qualification and management. With 100+ years of combined experience in medical device and IVD, our management team had been involved with 1,000+ CFDA certificates and also helped 200+ companies with their success in China. To serve our clients better, CMD has established local offices in Boston in the US and in Beijing and Suzhou in China. So contact us today by email or call 978-390-4453 to accelerate your medical device/IVD product’s entry into China.

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