1. New Good Manufacturing Practice for Medical Devices Released, to Take Effect in 2026
On November 4, the NMPA released the revised Good Manufacturing Practice for Medical Devices, which will take effect on November 1, 2026. Updated from the 2014 version, the regulation aims to strengthen medical device companies’ quality management systems and raise the industry’s overall standard. The new regulation contains 15 chapters and 132 articles, adding sections on quality assurance, verification and validation, and commissioned manufacturing and outsourced processing. It also reinforces quality risk management across the full lifecycle from R&D to after-sales service, supports digital and intelligent transformation, ensures product safety and effectiveness, and drives high-quality development in the medical device industry. This move is of great significance to safeguarding public safety in device use.
2. The U.S. FDA Issues Draft QMSR Implementation Guidance for Device Manufacturers
The U.S. FDA has issued a draft guidance on QMSR implementation for device manufacturers, clarifying the information required for PMA and HDE submissions and formally beginning compliance assessment on February 2, 2026. The guidance strengthens risk management and transparency, allows inspectors to review audit results, and also requires manufacturers to conduct gap analyses and establish ISO-compliant procedures. Companies already aligned with ISO 13485 will be less affected.
3. The NMPA Notifies 4 Medical Device Companies of Serious Quality Management Deficiencies
The National Medical Products Administration conducted unannounced inspections of four medical device companies—扬州晓康, 江西锦胜, 西藏贝珠雅, and 青海瑞朗—and found serious deficiencies in their quality management systems. Major issues included missing production records, inadequate execution of inspection procedures, and improper control of nonconforming products, all of which failed to comply with the Good Manufacturing Practice for Medical Devices. Provincial drug regulatory authorities in the relevant localities have taken measures in accordance with the law, ordering the companies involved to suspend production and carry out corrective actions to eliminate safety risks. Production may resume only after passing reinspection. The action reflects the country’s stringent regulatory requirements for the medical device industry.
4. Plan to Enhance Digital Management Capabilities of Certification Bodies Released
The State Administration for Market Regulation released the Guiding Opinions of the CNCA on Improving the Digital Management Capabilities of Certification Bodies, and plans to formulate the industry standard Technical Guidelines for Digital Management of Certification Bodies in 2025 to guide digital management efforts. By 2029, the goal is to fully implement the standard, with more than 30 certification bodies equipped with advanced digital infrastructure and using data analytics and other tools to support innovation in certification services. The initiative emphasizes strengthening digital management platforms, improving the quality of basic certification data, encouraging the development of digital support tools, and increasing resource investment and organizational knowledge-sharing to accelerate digital management across the industry.
5. Labeling Issue Leads to Canadian Recall of Rocket® Thoracic Drainage Kit
Health Canada has issued a medical device recall notice for the Rocket Seldinger thoracic drainage kit. The recall covers seven lots and is primarily due to an error in the instructions for use (IFU), which incorrectly described the use of suture or fixation devices; in fact, suturing is mandatory. The manufacturer is providing customers with updated instructions making clear that suturing is required.
6. FDA to Hold Meeting on V-Wave Atrial Shunt System
The U.S. Food and Drug Administration (FDA) announced that it will hold a public advisory committee meeting on December 3, 2025, to discuss V-Wave’s premarket approval application for the Ventura interatrial shunt system. The device is intended to offer a new treatment option for patients with severe chronic heart failure by shunting blood from the left atrium to the right atrium to improve symptoms. The meeting will be held online, and the public may submit comments electronically or in writing by the deadline of January 3, 2026. All comments submitted by then will be considered and made available for public review.
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