China's NMPA Reports on the Fifth Batch of Illegal Online Sales of Medical Devices
China's NMPA has escalated its efforts against illegal online sales of medical devices, announcing the fifth batch of enforcement actions on March 27, 2024. This initiative focuses on enhancing online sales supervision and utilizing a national monitoring platform to identify and address illegal activities. Recent investigations have led to penalties for unauthorized sales and sales of unregistered medical devices on various platforms, emphasizing the need for compliance with medical device regulations. The NMPA's strict measures aim to ensure the safety and legality of medical device usage, reinforcing public health protections by penalizing non-compliant practices in the industry.
Read MoreNavigating the Classification of RF Therapy Devices: A Comprehensive Analysis
The National Medical Products Administration (NMPA) issued a clarification on March 27, 2024, regarding the classification of Radiofrequency (RF) Therapy Devices, categorizing certain RF devices for skin treatment as Class III medical devices. This directive, part of the adjustments under Announcement No. 30 (2022), aims to ensure rigorous regulatory oversight for RF devices used in therapeutic skin treatments, emphasizing safety and efficacy. The move by the NMPA sets a clear regulatory path for the development and use of RF therapy devices, aligning with patient safety and product innovation standards.
Read MoreChina's NMPA Announces 2024 Medical Device Industry Standard Revision Plan
The National Medical Products Administration (NMPA) has announced a plan to revise 98 medical device industry standards in 2024, aiming to enhance safety, efficacy, and quality in response to evolving healthcare needs in China.
Read MoreChina Strengthens Medical Device Quality with 2024 Spot Check Inspection Initiative
China's National Medical Products Administration (NMPA) has launched the 2024 Medical Device Spot Check Plan, targeting a wide array of devices for quality and safety inspections, mandating provincial drug regulatory authorities and relevant authorities to conduct thorough inspections, address non-compliance with immediate risk control measures and legal actions, and ensure the medical device sector meets the highest safety and efficacy standards, underscoring the country's commitment to public health and regulatory compliance.
Read MoreChina's NMPA Releases New Guidelines for Usability Engineering in Medical Device Registration
On March 19, 2024, the National Medical Products Administration's (NMPA) Center for Medical Device Evaluation in China released the "Guidelines for Usability Engineering in Medical Device Registration," aiming to standardize usability engineering practices for medical devices to ensure their safety and effectiveness through improved user interface design.
Read MoreChina's NMPA CMDE Releases Five New Registration Review Guidelines for Medical Devices
China's NMPA CMDE has introduced five new registration review guidelines for specific medical devices, including Monkeypox Virus Nucleic Acid Test Kits, Corneal Topography Devices, Laparoscopic Surgical Systems, and Medical Device Optical Radiation Safety, bringing the total number of effective guidelines to 613 by the end of 2023, covering 92.2% of China's medical device classification catalog.
Read MoreNMPA Seeks Feedback on Draft Regulations for Clinical Trial Institutions Supervision
The National Medical Products Administration (NMPA) is seeking feedback on draft regulations for the supervision and audit of clinical trial institutions for medical devices. These regulations aim to enhance management practices and standardize audit processes. The guidelines, developed in alignment with existing regulations and good clinical practices, outline 16 audit sections and 96 items, covering institution and clinical trial profession aspects. Defects are classified as severe, major, or general, with conclusions drawn based on the severity of non-compliance.
Read MoreNational Medical Products Administration Approves Registration of 193 Medical Devices in February 2024
The approval of 193 medical devices by NMPA in February 2024, including advanced Class III and Class II equipment, marks a significant advancement in healthcare technology, catering to diverse medical needs and enhancing patient care.
Read MoreDisposable Heart Pulse Field Ablation Catheter Approved for Market Launch
In March 2024, the National Medical Products Administration approved Hangzhou Dinova's registration application for the innovative "Disposable Heart Pulse Field Ablation Catheter." This catheter, utilized with the company's ablation instrument, delivers targeted pulse field energy to induce precise, irreversible damage to myocardial cells, effectively treating various forms of atrial fibrillation. The product offers expanded treatment options for drug-resistant and recurrent cases, marking a significant advancement in cardiac care.
Read MoreAveir Leadless Pacemaker VR by Abbott Medical Receives Important Regulatory Approval
Abbott Medical's Aveir Leadless Pacemaker VR, designed for patients with severe bradycardia and offering MRI safety and rate-adaptive pacing, has received regulatory approval following extensive clinical and safety evaluations.
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