NMPA Releases the 2025 Medical Device Industry Standards Revision Plan
The NMPA released the 2025 Medical Device Standards Plan, detailing 6 mandatory and 79 recommended standards covering AI, nanotechnology, biomaterials, and robotics. Some standards align with international benchmarks to enhance global competitiveness. The plan promotes high-quality development through collaboration among regulatory bodies, ensuring safety, innovation, and compliance.
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 MoreNMPA Announces 10 New Medical Device Industry Standards
The National Medical Products Administration (NMPA) of China has announced 10 new medical device industry standards. These standards cover various medical devices including hemodialysis systems, surgical implants, high-frequency ventilators, and in vitro diagnostic reagents. The standards will be implemented between March 2026 and March 2028, aiming to enhance medical device safety and quality control.
Read MoreChina's Medical Device Standards System Achieves Major Milestone in 2024
In 2024, China's medical device standardization system reached a significant milestone with over 2,000 active standards. The advancement reflects a transition from broad framework to detailed implementation, strengthening industry regulation and safety assurance under the "Four Strictest" requirements in healthcare management.
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 Unveils Major Reform Plan for Pharmaceutical Industry Regulation
China's State Council has released comprehensive guidelines aimed at reforming drug and medical device regulation through 2035. The plan focuses on accelerating industry innovation, streamlining approval processes, and enhancing regulatory oversight to transform China into a global pharmaceutical powerhouse.
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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