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:
The NMPA granted innovative device status to seven devices, including two imported ones: Siemens Healthcare: X-ray Computed Tomography Equipment P+F Products + Features: Transcatheter Bicaval
The Greater Bay Area (GBA) – with a total population of approximately 71.2 million people (5% of China’s total population) – includes nine mega-cities of
The NMPA released the Medical Devices Standards Annual Report on February 18, 2022. In the year of 2021, 35 national standards and 146 industry standards
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 granted Innovation Approval to four neurological devices in January 2022: Beijing Pinchi: Dual-channel Implantable Deep Brain Stimulation System Beijing Pinchi: Implantable Spinal Cord
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
Three fast-track channels have been established by the NMPA to encourage innovation and deal with unmet medical needs: Innovation Approval, Priority Review, and Emergency Approval.
The NMPA issued the “Optimizing Mandatory Standards for Medical Devices (Draft)” on January 5, 2022 for feedback. Feedbacks need to be submitted by February 10.
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