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2026 China NMPA Bluebook is here:
Unique Device Identification (UDI) will be implemented with all Class III devices and IVDs, effective from June 1, 2022. It was announced by NMPA at
The NMPA issued the “2022 Medical Device Industry Standards Revisions Plan” today, April 14, 2022, for public opinions. Comments need to be submitted by April
Here’s the latest China regulatory and clinical affairs China NMPA News March 2022 for medical device and IVDs pros. These updates are presented by China
The NMPA and China Health Commission released the “Quality Management Practice Specification for Clinical Trials of Medical Devices”, implemented from May 1, 2022. The “China
Hainan Lecheng Boao International Medical Pilot District released “Pilot Trials of International Innovative Neurological Products” on March 29, 2022, to solicit imported products from neurological
The NMPA reclassified certain neurosurgical, cardiac surgery, orthopedic, and aesthetic devices and modified intended use for some with an announcement on March 24, 2022. NMPA
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