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2026 China NMPA Bluebook is here:
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
“Selection of Urgent Needed Drugs and Medical Devices for Insurance Application” was published by Hainan Boao Tourism Pilot Zone Administration on February 10, 2022. It
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
Here’s the latest China NMPA regulatory and clinical affairs news for medical device and IVDs pros in January 2022. These updates are presented by China
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
If devices are not on the clinical evaluation exempt catalog but have an NMPA-approved predicate device to show substantial equivalence, per the “Guidance for Clinical
The NMPA issued the “Guideline on Artificial Intelligence Medical Devices (Draft)” on June 4 for feedback. The document is to direct manufacturers on how define,
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.