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2025 China NMPA Bluebook is here:
The NMPA issued five IVD draft guidelines on October 1, 2022, soliciting public opinions. Feedbacks need to be submitted by October 22, 2022. Full List of 5 IVD Draft Guidelines
The NMPA released the “Draft Guideline on Continuous Glucose Monitoring System” on September 28, 2022, for feedback. Feedback needs to be submitted by October 14, 2022. Highlights of the NMPA
NMPA In Vitro Diagnostic Reagents The NMPA In vitro diagnostic reagents issued 6 guidelines on September 28, 2022: Guideline on Qualitative Detection In Vitro Diagnostic Reagent Analysis Performance Evaluation Guideline
The NMPA published the 27 registration review guidelines on September 15, 2022, which involve a wide range of indications, from chemistry, hematology to dental and urology, etc. It is to
The NMPA released eleven filing review guidelines on September 1, 2022. Equivalent to FDA’s Acceptance and Filing Reviews, it is intended to be used by NMPA reviewers and the device
The NMPA published ten draft guidelines for IVDs on June 23, 2022, for feedback. They are proposed to direct manufacturers for local type testing and regulatory approval. IVD Guidelines NMPA
The NMPA published the “2021 Medical Device Guidelines Revisions Plan” on June 23, 2022, in which 75 guidelines are affected. The revisions are aimed to facilitate manufacturers with local type
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros issued in April 2022. These updates are presented by China Med Device, LLC, your partner
According to the “Administrative Measures for Registration and Filing of Medical Devices” and “Administrative Measures for Registration and Filing of In Vitro Diagnostic Reagents”, the medical device testing report can
The NMPA released three guidelines in a single day, March 9, 2022 in an effort to regulate and support the rapid development in digital health: Guideline for Artificial Intelligence in
What does China PTR do in Total Product Life Cycle? With the release of Regulations on the Supervision and Administration of Medical Devices, Measures for the Administration of Medical Device
The NMPA “Medical Device Registration and Filing Management Measures” and “In Vitro Diagnostic Reagents Registration and Filing Management Measures” have been effective since October 1, 2021. The new registration measures
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