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2025 China NMPA Bluebook is here:
The NMPA granted Innovation Approval to four medical devices in the first week of November 2021: Zhongyi Kangwei: Preimplantation Chromosome Aneuploidy Detection Kit Zhuo Ruan Medtech: Biological Hernia Repair Patch
The NMPA published the “Registration Review Guideline for Domestic Class III and Imported Medical Devices”, specifying working processes and timelines of registration application, clinical application and change application. The document
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in October 2021. These updates are presented by China Med Device, LLC, your partner in
Unlike the “Medical Device Classification Rules”, the NMPA did not separately regulate the classification of IVD reagents before. Instead, the guidelines were written into the “Notice on Issuing the Registration
The NMPA issued a notice “Interpretation of Regulations on Self-test of Medical Device Registration” on October 27, 2021, explaining the self-test report guideline in details. Decree 739 Regulation on Supervision
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
One giant leap from China medical device regulators—the NMPA began to recognize self-test report from manufacturers, with detailed guidebook on how to self-test. After two drafts, the NMPA finalized document
The NMPA issued the “Notice regarding implementation of Medical Device Registration and Filing Management Measures and In Vitro Diagnostic Reagents Registration and Filing Management Measures” which have been effective since
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in September 2021. These updates are presented by China Med Device, LLC, your partner in
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
Unique Device Identification (UDI) will be implemented with all Class III devices, announced by NMPA at the “Notice on Applying Unique Device Identification System for the Second Group of Devices”