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2023 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 released the final version of “Registration Guideline for Radiofrequency Aesthetic Devices” on April 12, 2023. The draft document was released on August 26, 2022, for feedback. The radiofrequency
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 granted innovation approval to Boston Scientific for the Sentinel Cerebral Protection System on November 2, 2022. The device belongs to “first-of-its-kind in China” scenario. CMDE released the review
The NMPA released the “Draft Guideline on Continuous Glucose Monitoring System” on September 28, 2022, for feedback. Feedback needs to be submitted by October 14, 2022. Highlights of the NMPA
The NMPA reclassified 27 medical devices and modified intended use for some with an announcement on March 30, 2022. Among them, 16 devices are applied in cosmetic surgery. From April
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 positron emission/X-ray computed tomography (PET/CT system). Both technical and clinical requirements are outlined below.
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 granted Innovation Approvals to two pieces of equipment in April 2022: Radiology: Magnetic resonance imaging system Orthopedic: Hip replacement surgery navigation and positioning system NMPA issued the list
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
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