Medical Devices Archive

Healthcare professional in a clinical laboratory or surgical setting holds and points to a bone model fitted with an orthopedic fixation plate and screws, illustrating medical device design and implantation for orthopedic treatment. The scene includes sterile instruments and medical equipment in the background, suggesting a regulated healthcare environment relevant to medical device regulatory compliance, product registration, and market access considerations in China and the Asia-Pacific region.

Tuesday, 31, March, 2026 / Published in China, Medical Devices, News

China NMPA Issues 26 Medical Device Standards Affecting Orthopedics, IVDs, & Software

China’s National Medical Products Administration (NMPA) issued “Announcement of the National Medical Products Administration on the Release of 26 Medical…

Close-up of a healthcare professional using a handheld barcode scanner to scan labeled sterile medical device packages organized in a metal cart with multiple wire baskets. The sealed items include tubing, syringes, and clinical supplies, each with printed labels and QR codes for inventory tracking and traceability. The scene reflects hospital inventory management and medical device handling, relevant to regulatory compliance, product registration, and quality control processes in China and broader Asia-Pacific market access environments.

Thursday, 26, March, 2026 / Published in China, Medical Devices, News

China Mandates Full UDI Compliance for All Medical Devices by 2029

On March 13, 2026, China’s National Medical Products Administration (NMPA), together with the National Health Commission and the National Healthcare…

Healthcare professional in blue scrubs adjusts a patient’s head positioning as they lie on a hospital bed entering an MRI scanner, while another clinician observes brain scan images on a monitor in a clinical imaging room. The scene highlights medical diagnostics, imaging technology, and patient care processes relevant to healthcare systems, with potential implications for regulatory compliance, medical device approval, and market access in China and Asia-Pacific healthcare environments.

Wednesday, 25, March, 2026 / Published in China, Medical Devices, News

China NMPA Clarifies Pre-Review for Innovative Device Clinical Trials

On March 13, 2026, China’s National Medical Products Administration (NMPA) Center for Medical Device Evaluation (CMDE) issued the notice “Notice…

Wednesday, 18, March, 2026 / Published in China, Medical Devices, News

China NMPA Releases 2025 Medical Device Registration Data Report

On February 24, 2026, the National Medical Products Administration (NMPA) released the “2025 Annual Report on Medical Device Registration,” outlining…

Tuesday, 17, March, 2026 / Published in China, Medical Devices, News

China NMPA Releases 2025 Medical Device Standardization Management Report

On February 24, 2026, the National Medical Products Administration released the “Annual Report on Medical Device Standardization Management in China…

Thursday, 12, March, 2026 / Published in China, Medical Devices, News

China Seeks Comments on Draft 2026 Class III Clinical Trial Approval Catalogue

On February 3, 2026, the Center for Medical Device Evaluation (CMDE) released the “Catalogue of Class III Medical Devices Requiring…

Monday, 2, March, 2026 / Published in China, IVDs, Medical Devices, News

China NMPA Issues 2026 Medical Device Industry Standards Development and Revision Plan

On February 11, 2026, the National Medical Products Administration (NMPA) published “Notice on Issuing the 2026 Medical Device Industry Standards…

Monday, 2, March, 2026 / Published in China, Medical Devices, News

China CMDE Releases 2026 Revision Guideline for Aesthetic HA Fillers

On February 6, 2026, the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA) issued “Announcement on Releasing the…

Thursday, 5, February, 2026 / Published in China, Medical Devices, News

China Seeks Comments on Draft 2026 Class III Clinical Trial Approval Catalogue

On February 3, 2026, the Center for Medical Device Evaluation (CMDE) released the “Catalogue of Class III Medical Devices Requiring…

Thursday, 29, January, 2026 / Published in China, IVDs, Medical Devices, News

China NMPA Clears 104 Innovative Medical Devices for Special Review in 2025

In 2025, China’s National Medical Products Administration (NMPA), through its Center for Medical Device Evaluation (CMDE), released 12 batches of…

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