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2026 China NMPA Bluebook is here:
If devices are not on the clinical evaluation exempt catalog but have an NMPA-approved predicate device to show substantial equivalence, per the “Guidance for Clinical Evaluation of Medical Devices” published
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,
NMPA published the “Evaluation of the Safety and Effectiveness of Medical Devices Containing Nanomaterials Part I: Framework” on August 30, 2021, directing manufacturers on key issues of nanomaterials’ registration. The
The new “Regulation for Medical Device Administration and Supervision”, Order 739, effective since June 1, 2021, allows the implied permission for class III devices conducting clinical trial. It states that,
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros for November 2021. These updates are presented by China Med Device, LLC, your partner in
NMPA published the “Medical Device Clinical Trial Data Submission Guideline” and “In Vitro Diagnostic Reagent Clinical Trial Data Submission Guideline” on November 25, finalizing the draft issued in mid-September. They
The published the “Clinical Evaluation Guideline for In Vitro Diagnostic Reagents Listed in Catalog of Clinical Trial Exemption” and “Clinical Guideline for In Vitro Diagnostic Reagents” on September 24 and
The NMPA published the “Guideline on Decision Making of Conducting Clinical Trial for Medical Devices” on September 28, 2021, directing manufacturers on how to decide if clinical trial is necessary
The NMPA released the “Catalog of Medical Devices and IVD Products Exempted from Clinical Trials” on September 18, 2021, which includes 1010 devices and 423 IVDs. It is an effort
The NMPA issued eight draft guidelines to regulate the clinical pathways in May. Feedback needs to be submitted to the NMPA by May 30, 2021. Complete List Medical Device Clinical
ChinaMed Device, LLC (CMD), a leader in helping medtech/IVD companies with RA, QA and CRO in China, has successfully helped a medical device company to get clinical trial and NMPA