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
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 Valves System United Imaging: Magnetic
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 for medical devices were published.
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 granted Innovation Approval to four neurological devices in January 2022: Beijing Pinchi: Dual-channel Implantable Deep Brain Stimulation System Beijing Pinchi: Implantable Spinal Cord Stimulation System Beijing Pinchi: Implantable
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.
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. For Priority Review, applicants for
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 document lists 458 standards,