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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
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 document lists 458 standards,
The NMPA held a conference in Beijing on December 27, 2021 to discuss the Real World Data program and better enhance the approval system for imported devices. Allergan’s Glaucoma treatment
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 equipment. Indication and composition
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 four medical devices in the first week of November 2021: Zhongyi Kangwei: Preimplantation Chromosome Aneuploidy Detection Kit Zhuo Ruan Medtech: Biological Hernia Repair Patch
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