Register for Upcoming Webinar on DEC. 8 @ 11AM
2026 China NMPA Bluebook is here:
The NMPA released three guidelines in a single day, March 9, 2022 in an effort to regulate and support the rapid development in digital health:
What does China PTR do in Total Product Life Cycle? With the release of Regulations on the Supervision and Administration of Medical Devices, Measures for
The NMPA “Medical Device Registration and Filing Management Measures” and “In Vitro Diagnostic Reagents Registration and Filing Management Measures” have been effective since October 1,
The NMPA released the “Guideline for Medical Device Product Technical Requirements (PTRs)” on February 9, 2022, directing manufacturers on preparing one of the most important
The NMPA released the “Registration Guideline on Combination Products with Device as Primary Mode of Action” on January 11, 2022, directing manufacturers for safety and
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
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 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
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.
NMPA published six guidelines in August 2021: Guideline for Safety and Effectiveness Evaluation of Medical Devices Using Nanomaterials Part 1: System Framework Guideline for Nomenclature
Manufacturers have long been concerned that when applying for drug-device combination product registration, in addition to original country approval for the combination product, the submission