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2026 China NMPA Bluebook is here:
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
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 “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 published the “Registration Review Guideline for Domestic Class III and Imported Medical Devices”, specifying working processes and timelines of registration application, clinical application
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
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
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.
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
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”
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