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2026 China NMPA Bluebook is here:
We want to share the highlights of China regulatory submission case from NMPA reviewers’ perspectives on an iliac vein stent system. Both technical and clinical
The NMPA granted Innovation Approvals to two pieces of equipment in April 2022: Radiology: Magnetic resonance imaging system Orthopedic: Hip replacement surgery navigation and positioning
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,
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 granted innovation approval to Suzhou LinaTech for the electron linear accelerator, and CMDE (Center for Medical Device Evaluaiton) issued the Review Report for
The NMPA published the “Catalog of Medical Devices Prohibiting of Entrusted Production” on November 17, 2021, providing the scope of 22 devices which are not allowed for contract manufacturing.
The NMPA granted Innovation Approval to four medical devices in the first week of November 2021: Zhongyi Kangwei: Preimplantation Chromosome Aneuploidy Detection Kit Zhuo Ruan
The NMPA granted Innovation Approval to three medical devices in September 2021: Dental implant surgery navigation and positioning equipment Ultrasonic diagnostic equipment for endoscope Transcatheter
NMPA published six guidelines in August 2021: Guideline for Safety and Effectiveness Evaluation of Medical Devices Using Nanomaterials Part 1: System Framework Guideline for Nomenclature
NMPA granted ten special statuses in August 2021, among them are seven innovation cardio devices: Boston Scientific Corporation: Vascular Plaque Atherectomy System TriReme Medical: Paclitaxel
NMPA issued the “Artificial Intelligence Medical Software Classification Guideline” on July 8, 2021, to direct manufacturers for the classification and the corresponding clinical data and
The NMPA granted four innovation review statuses on June 22, 2021, three innovation cardio devices which are cardiovascular-related and one for intraperitoneal surgery: Chengdu Sailanuo