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2026 China NMPA Bluebook is here:
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
The NMPA released 19 industry standards on December 10, 2021, with indications ranging from cardiovascular, plastic surgery, oncology, clinical chemistry and immunology, etc. The standards
The NMPA released the “Communication Standards for Innovation Approval and Priority Review” on December 1, effective from the date of publication. The standards are to
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
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
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
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
The NMPA published the revised version of “Medical Device Animal Study Guideline Part 1: Decision-making Principles” and “Medical Device Animal Study Guideline Part II: Test
The NMPA published the “Catalog of Medical Devices Prohibiting of Entrusted Production” on November 17, 2021, providing the scope of 22 devices which are not allowed for contract manufacturing.
The NMPA issued the “Adjustment of Med Device Classifications Catalog (Draft)” on November 12, 2021, in a proposal to readjust classification, intended use and example
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
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