China Med Device

NMPA published 5 medical devices final guidelines on April 9, 2026. They are aimed to facilitate manufacturers with clarity in type testing, non-clinical and clinical evaluation and regulatory submission. The guidelines concern the devices below: Why Overseas Manufacturers Should Pay Close Attention Intravascular ultrasound diagnostic equipment has long been dominated by a fe...

The NMPA issued an inspection result on March 31, 2026 for German manufacturer KARL STORZ’s High-frequency Surgery System. NMPA organized a remote inspection of KARL STORZ. It was found that the company “has deficiencies in its quality management system regarding product software version control, analysis and handling of adverse events, and performance of the management […]

NMPA announced the “2026 National Inspection Plan for Medical Devices” on April 8, 2026. The Plan asks provincial NMPA offices and testing centers to conduct quality inspections based on Mandatory Standards and Product Technical Requirements (PTRs). Full List The plan covers 76 medical devices and IVDs. NMPA lists the inspection items for each product. Email […]

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Here’s the latest China regulatory and clinical affairs news for medical device and IVDs pros in April 2026. These updates are presented by China Med Device, LLC, your partner in Chinese market access. Policies NMPA Enables Early Regulatory Feedback on Innovative Medical Device Clinical Trial Protocols The NMPA issued the “Pre-Review of Clinical Trial Protocols […]

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On March 24, 2026, NMPA published draft versions of registration review key points for 18 medical devices. Once finalized, the documents aim to provide manufacturers with clearer guidance on testing, clinical evaluation and registration requirements. This marks the second time that feedback has been sought for the key points concerning tumor gene variation detection reagents,...