China's National Medical Products Administration (NMPA) has issued Notice No. 14 of 2026, releasing new inspection guidelines aligned with the revised Medical Device Production Quality Management Regulations (GMP), which take effect November 1, 2026. The guidelines replace the 2015 version and set out transition arrangements, risk-based post-market inspection requirements, and specify that sterile, implantable, IVD reagent, custom denture, and standalone software devices must comply with both the new GMP and existing appendix requirements.

On June 8, 2026, China's NMPA, jointly with three other national health authorities, issued the revised "Good Clinical Practice for Drug Clinical Trials," effective September 1, 2026, replacing the 2020 version. The update aligns closely with ICH E6(R3), restructuring the GCP into six chapters and adding a new Data Governance chapter to strengthen data reliability and traceability. It sharpens accountability—designating principal investigators as ultimate on-site responsible parties and sponsors as bearing final trial responsibility—while reinforcing participant protections, particularly for vulnerable populations and informed consent.

China's National Medical Products Administration (NMPA) issued Announcement No. 52 (2026) on June 1, 2026, establishing comprehensive procedural requirements for the registration and filing of medical devices — including in vitro diagnostic reagents — following regulatory classification adjustments. The announcement addresses a broad range of scenarios, including first-time registration, renewal, product changes, and transitions between filing and registration categories, while setting clear deadlines and responsibilities for both manufacturers and regulatory authorities. Products that fail to obtain valid registration or complete required filings before the applicable transition deadline will be prohibited from manufacture, distribution, and import. The announcement took effect immediately upon publication.

On April 8, 2026, China's NMPA officially launched its 2026 National Medical Device Quality Sampling Inspection Program, covering 74 device categories spanning implantables, diagnostics, therapeutic equipment, and surgical consumables. Provincial and national testing institutions are mandated to conduct inspections against mandatory standards and approved product technical specifications, with non-compliant manufacturers required to immediately implement risk control measures — and cases involving potential criminal liability referred to judicial authorities. The program reflects China's continued commitment to strengthening medical device quality oversight and advancing patient safety across a broad spectrum of high-risk and high-value device categories.