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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
The NMPA released the “Guideline for Medical Device Product Technical Requirements (PTRs)” on February 9, 2022, directing manufacturers on preparing one of the most important documents submitting to NMPA. What
The NMPA released the “Registration Guideline on Combination Products with Device as Primary Mode of Action” on January 11, 2022, directing manufacturers for safety and efficacy evaluation of combination products.
The NMPA published 34 guidelines in December 2021, involving provisions on clinical trials, same-variety comparison, and regulatory review for a wide range of indications. Significantly referred to many FDA guidance,
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