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2026 China NMPA Bluebook is here:
“Selection of Urgent Needed Drugs and Medical Devices for Insurance Application” was published by Hainan Boao Tourism Pilot Zone Administration on February 10, 2022. It asks foreign manufacturers to submit
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,
The NMPA granted innovation approval to Suzhou LinaTech for the electron linear accelerator, and CMDE (Center for Medical Device Evaluaiton) issued the Review Report for the equipment. Indication and composition
NMPA published the “Guideline for Overseas Clinical Data Acceptance on In Vitro Diagnostics” on December 3, 2021, finalizing the draft version issued in late November 2020. Clinical data generated outside
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
Hainan NMPA published “Guideline for Importation of Urgently Needed Drugs and Medical Devices in Hainan Free Trade Port Boao Lecheng International Medical Tourism Pilot Zone” on October 15, 2021, directing
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