In a recent conference held from October 31 to November 1, the National Medical Products Administration’s Medical Device Technical Evaluation Center (Center) showcased groundbreaking advancements in leveraging real-world evidence for clinical assessments of medical devices. The Second Boao International Conference on Real-World Medical Device Research, themed “International Real-World Data Research and Scientific Development of Medical Device Regulation,” provided a platform for discussions on crucial topics within the field.
China Hainan Province has recently put into effect the “Management Measures for the Carrying and Use of Clinically Urgent Imported Drugs and Medical Devices,” a set of regulations designed to ensure the safe and controlled use of medications and medical devices by patients after they are discharged from medical hospitals.
Recently, NMPA conducted unannounced inspections of four enterprises and found the following major deficiencies in their quality management systems, which will be divided into several major aspects:
Organization personnel：The person in charge of the enterprise and other relevant management personnel are not familiar with the regulations and cannot make judgment and deal with the problems arising in production management and quality management. At the same time, the enterprises do not have insufficient training of employees on relevant laws and regulations, and the relevant personnel have insufficient ability to recognize product production compliance risks and quality and safety risks. Therefore, the enterprises do not comply with the clause of Good Manufacturing Practice for Medical Device that the personnel engaged in work affecting product quality should be trained to meet the requirements of their positions, with relevant theoretical knowledge and practical skills requirements.
In a significant regulatory update, China’s National Medical Products Administration (NMPA) has announced a comprehensive overhaul of the classification and supervision of radiofrequency (RF) beauty treatment devices. The changes mark a transition from lenient oversight to stringent regulation, aligning with the administration’s commitment to ensuring consumer safety and product efficacy.
The National Medical Products Administration (NMPA) has released findings from its recent quality inspection, revealing that 20 batches of medical devices across 11 categories have failed to meet the necessary compliance standards.
