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2026 China NMPA Bluebook is here:
The article below is written by Liang Peng, AI expert and Deputy Minister of Evaluation Department I of CMDE (Center for Medical Device Evaluation) and
The NMPA published the “Catalog of Medical Devices Prohibited from Contract Manufacturing” on March 24, 2022. Compared with the draft version, issued in November 2021,
According to the “Administrative Measures for Registration and Filing of Medical Devices” and “Administrative Measures for Registration and Filing of In Vitro Diagnostic Reagents”, the
The NMPA granted approvals to two devices, Boston Scientific’s Rezūm Water Vapor Therapy equipment, and its disposable prostate treatment accessory on March 3, 2022. It
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
Here are the latest China regulatory and clinical affairs news pieces for medical devices and IVDs in February 2022. These updates are presented by China
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,