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2026 China NMPA Bluebook is here:
The NMPA reclassified 27 medical devices and modified intended use for some with an announcement on March 30, 2022. The classification and definition of the
With the rapid development of the industry and continuous emergence of new technologies, new materials and new products, the “Medical Device Classification Catalog”, effective from
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 published 33 review reports from January to April 2022. Three categories are included: innovation, priority review and Class III predicate-comparison devices. Overseas manufacturers
Hainan Boao special zone allows overseas unapproved medical devices, IVDs, drugs in China to be used. In addition to the overseas medical products being sold
Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros issued in April 2022. These updates are presented by China
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 finalized the “2022 Medical Device Industry Standards Revisions Plan” on April 28, 2022, just two weeks after the draft version. The plan includes
The NMPA issued the “Clinical Pathway Recommendations for Certain Active and Passive Implantable Devices” on April 6, 2022. The document suggests manufacturers how to choose
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