NMPA Issues Inspection Guidelines for Newly Revised Medical Device Production Quality Management Regulations
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.
Read MoreChina Unveils Major Overhaul of Drug Clinical Trial Standards, Aligning with Global ICH Guidelines
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.
Read MoreChina NMPA Issues Announcement on Medical Device Classification Adjustment Procedures
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.
Read MoreChina’s NMPA Issues New Regulations on Medical Device Export Sales Certificates
China's National Medical Products Administration (NMPA) has released updated regulations for medical device export sales certificates, effective May 1, 2026, replacing the 2015 version. The new rules establish two certificate types: Type I for devices already registered in China and Type II for unregistered devices whose manufacturers meet GMP standards. Applications will be processed within 20 working days through provincial authorities, with certificate validity capped at three years for Class I devices. The regulations introduce stricter accountability measures, including a five-year ban for fraudulent applications, while emphasizing that companies remain responsible for ensuring compliance with importing countries' requirements. The NMPA characterized the update as a service measure to facilitate medical device exports while maintaining quality and regulatory standards.
Read MoreChina Introduces New Policy to Boost Domestic Production of Imported Medical Devices
China's National Medical Products Administration updated policies to facilitate domestic production of imported Class II and III medical devices on March 18, 2025. The measures simplify registration through shared materials, prioritize innovative products, and ensure quality control through system inspections. These reforms aim to attract foreign investment, streamline processes, and enhance China's medical device industry.
Read MoreChina Issues New Guidelines for Neurological Medical Service Pricing
China's National Healthcare Security Administration (NHSA) has issued new trial guidelines for neurological medical service pricing, reorganizing services into 82 basic items, 24 additional charges, and 8 expanded items. This reform enables provincial authorities to establish price benchmarks and allows local adjustments, advancing China's healthcare pricing standardization efforts.
Read MoreNMPA Issues New Guidelines on Medical Device Clinical Trial Inspection
China's NMPA has announced new guidelines (No. 22 of 2025) for medical device clinical trial inspections, effective May 1, 2025. The rules establish clear criteria for evaluating both pending applications and approved devices, focusing on authenticity and compliance. This update replaces 2016 and 2018 regulations, strengthening clinical trial oversight.
Read MoreChina Shanghai Updates Pharmaceutical and Medical Device Regulations for 2025
The Shanghai Municipal People's Congress has approved new Pharmaceutical and Medical Device Regulations, effective March 1, 2025. The regulations strengthen product supervision while promoting innovation, featuring digital oversight, streamlined approval processes, and enhanced quality management. Key focuses include R&D support, regional cooperation, and safety standards modernization.
Read MoreChina Makes Minor Updates to Medical Device Regulations for 2025
China's State Council has announced two minor amendments to the Medical Device Supervision and Administration Regulations, set to take effect on January 20, 2025. The changes involve administrative authority adjustments and the removal of outdated terminology.
Read MoreChina's NMPA Seeks Public Input on Draft for Local Production of Imported Medical Devices
The General Office of the National Medical Products Administration (NMPA) of China has released a draft announcement titled "Announcement on Further Clarifying Matters Related to the Production of Imported Medical Device Products by Enterprises Within China (Draft for Comments)" on November 4, 2024. The NMPA is now openly soliciting public opinions on this draft to deepen medical device regulatory reforms and promote high-level industrial openness, aiming to better meet the public's needs for medical devices.
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