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2024 China NMPA Bluebook is here:
China’s NMPA issued a notice titled “Information Collection from Enterprises and Institutions Related to the Preparation of the Guideline for Intracranial Coils and Guideline for Stent Retrievers” on May 17,
The NMPA issued a notice summarizing device approvals in January 2023. In total of 23 imported Class II and III were approved, among them are two implantable cardiac resynchronization cardioverter
The NMPA issued the “Guideline of Drug-coated Balloon Dilatation Catheter (draft)” today on June 22, 2022, collecting public opinions. Feedbacks need to be submitted by July 22, 2022. Referring to
NMPA issued the “Clinical Pathway Recommendations for Certain Categories of Medical Devices” on June 16, 2022. The document suggests manufacturers how to choose clinical evaluation exemption, predicate device comparison or
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 requirements are outlined below. In
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, with 22 devices on the
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. NMPA has introduced the MAH
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 aortic valve and retrievable delivery
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 of Nerve and Cardiovascular Surgical
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 Drug-Coated Peripheral Balloon Catheter Shandong
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 regulatory submission. It is the
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 Medical: Endovascular Aortic Stenosis System
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