U.S. and GB device lifecycle controls are live; China’s revised GMP starts November 1

What changed

FDA’s Quality Management System Regulation took effect on February 2, 2026. It amended 21 CFR Part 820, incorporated ISO 13485:2016 and specifically required risk management. FDA also replaced the Quality System Inspection Technique with a new device-manufacturer inspection process. (fda.gov)

Great Britain’s post-market surveillance rules have applied since June 16, 2025. Manufacturers must maintain a surveillance plan, gather and analyse safety and performance information, link findings to risk management and corrective action, and prepare a post-market surveillance report or periodic safety update report according to device risk. (gov.uk)

GB manufacturers must report serious incidents within 15 days, submit Field Safety Notices for MHRA review before distribution and provide the latest surveillance report within three working days when requested. The rules apply to devices placed on the GB market or put into service from June 16, 2025; they are not backdated. (gov.uk)

China’s revised medical-device Good Manufacturing Practice takes effect on November 1, 2026. It extends risk management from research and design through after-sales service and adds provisions on quality assurance, validation and verification, contract manufacturing and outsourcing. (english.nmpa.gov.cn)

Why it matters

The three measures use different legal mechanisms. They nevertheless require manufacturers to manage quality evidence across the product lifecycle, not only in the premarket submission.

U.S. teams should test QMSR documentation, risk-management practices and inspection readiness against FDA’s current requirements rather than the former QSIT approach. GB teams need reliable links between complaints, vigilance, risk files, corrective and preventive action, technical documentation and surveillance reports. China teams have less than three months to close identified GMP gaps before November 1, 2026. (fda.gov)

A common operating model may support complaints, risk management, supplier controls and corrective action across markets. The legal procedures, reporting timelines and evidence packages must remain jurisdiction-specific.

These changes do not replace premarket review. FDA’s current draft guidance still addresses quality-system information required in certain premarket submissions. (fda.gov)

Who should pay attention

• Finished-device and accessory manufacturers distributing products in the United States.
• Manufacturers of UKCA- or CE-marked devices, including IVDs and active implantable devices, entering the GB market.
• Manufacturers supplying China, particularly companies using contract manufacturing or outsourced processes.
• Regulatory affairs, quality, vigilance, post-market surveillance, manufacturing, engineering, clinical, supplier-quality and risk-management teams. (fda.gov)

What to watch next

FDA may revise or finalize its October 2025 draft guidance on quality-system information for certain premarket reviews. Until then, the document remains non-binding and not for implementation. (fda.gov)

GB manufacturers should monitor MHRA guidance updates and maintain readiness for annual, two-year or three-year report cycles based on device classification. (gov.uk)

China manufacturers should watch for implementation instructions and inspection expectations before the revised GMP replaces the 2014 framework on November 1, 2026. (english.nmpa.gov.cn)

Sources

• FDA, “Quality Management System Regulation.” (fda.gov)
• FDA, “Quality Management System Information for Certain Premarket Submission Reviews.” (fda.gov)
• MHRA, “First major overhaul of medical device regulation comes into force across Great Britain.” (gov.uk)
• MHRA, “Requirements of the manufacturer’s PMS system.” (gov.uk)
• NMPA, revised medical-device GMP announcement and policy interpretation. (english.nmpa.gov.cn)