NMPA 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 The changes involve administrative authority adjustments and the removal of outdated terminology.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.
Read MoreNMPA Announces Results of National Medical Device Supervision and Inspection (Announcement No. 42 of 2024)
The National Medical Products Administration conducted a national inspection on 7 categories of medical devices, finding 11 batches/units that did not meet quality standards, including issues with ultrasound therapy equipment, high-frequency electrosurgical units, nebulizers, limb compression therapy equipment, dental cements, and dental products. The administration has ordered provincial authorities to take enforcement actions, require the manufacturers to assess risks, recall the non-compliant products, investigate the causes, and implement corrective measures.
China Beijing Establishes Green Channel for Importing Urgently Needed Drugs and Medical Devices
Beijing has announced a new initiative to streamline the import process for urgently needed drugs and medical devices. The Beijing Municipal Medical Products Administration, along with three other departments, has issued a trial implementation plan to create a "green channel" for the temporary import of clinically urgent medications and medical equipment.
China's NMPA Releases Updated Guidelines for Class III Ultrasound Imaging Devices
China's NMPA has released updated guidelines for Class III ultrasound imaging devices. Announced on October 14, 2024, the revised document aims to standardize management of these medical devices. It covers registration requirements, safety standards, software validation, and clinical applications. The guidelines reflect current regulations and technological advancements, serving as a resource for manufacturers and reviewers.