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: Guideline for Artificial Intelligence in
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 Administration of Medical Device
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, 2021. The new registration measures
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 documents submitting to NMPA. What
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 efficacy evaluation of combination products.