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NMPA Roundup September 2022


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Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros for September 2022. These updates are presented by China Med Device, LLC, your partner in Chinese market access.


Guangdong Encourages Devices to Localize There with a Simplified Registration Process

The Guangdong NMPA released the “Guideline on Registration of Approved Class II Medical Devices Moving into Guangdong Province (Trial)” to encourage medical device and IVD manufacturers to transfer the certificates into Guangdong province.

The Guangdong NMPA will process the technical review in 5 working days if the product classification is clear and the clinical evaluation evidence is sufficient. The guideline also applies to overseas manufacturers, through its sole proprietorship, joint venture, or authorized registration applicant in Guangdong, to transfer the imported Class II medical device and IVD registration certificate to Guangdong. See the expedited register pathway for the transfer.

Eleven Filing Review Guidance Published

NMPA released eleven filing review guidance on September 1, 2022. Equivalent to FDA’s Acceptance and Filing Reviews, it is intended to be used by NMPA reviewers and the device industry to help elucidate the broad clinical and registration issues that need to be addressed in the submission and key decisions to be made during the filing process.

Eleven documents are published regarding the filling review requirements for clinical trial and initial & renewal & modification registration. View more information.

Guidelines & Standards

Thirty-Seven Guidelines Issued in September

CMDE published 37 guidelines in September, including four draft documents which asks feedback. Feedbacks need to be submitted by October 14, 2022.

Review the six IVD guidelines. Look at more information on the four draft guidelines on glucose monitoring devices, ECMO and mobile ECG.

Read our comprehensive review on the guidelines of Continuous Glucose Monitoring System CGM.

Ninety-two Standards Become Non-Binding

The NMPA issued the “Announcement on the transformation of 92 mandatory industry standards and research projects for medical devices into recommended industry standards and research projects” on September 9, 2022. Devices from a range of indications, cardiovascular, ophthalmic, dental, and gynecology, etc. are impacted.

While Industry Mandatory Standards are legally enforced, the industry recommended standards are not legally binding but only recommended by regulatory authorities. See the list of standards.

Fast-Track Approvals

Review Report Released for ViewRay’s MRIdian Linac System

ViewRay Incorporated, from California, US, gained Class III approval for Magnetic Resonance-Guided Radiation Therapy, the first-of-its-kind in China, utilizing predicate-comparison pathway. NMPA issued a review report for the equipment.

The review report elucidates the regulatory pathway regarding device description, preclinical and clinical trial. Read more.

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