China'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.
Read MoreNew Chapter in Greater Bay Area Development: Hengqin Guangdong-Macao In-depth Cooperation Zone Implements VAT and Consumption Tax Refund Policies
The Hengqin Guangdong-Macao In-depth Cooperation Zone introduces VAT and consumption tax refund policies effective from March 1, 2024, to boost economic integration and development, marking a strategic effort to enhance business and trade attractiveness by treating certain imported goods as exports and facilitating tax refunds for qualifying businesses, thus fostering greater economic synergy between Guangdong province and Macao.
Read MoreChina Sets New Benchmarks in Medical Device Industry with Ambitious 2023 Standardization Initiatives
In 2023, China significantly advanced its medical device industry by approving and publishing a wide range of national and industry standards, establishing key standardization technical organizations, and reinforcing its commitment to safety, innovation, and global competitiveness.
Read MoreGuidelines for the Performance Evaluation of Pathological Image AI Analysis Software: Ensuring Accuracy and Compliance in Medical Diagnostics
The "Key Points for the Performance Evaluation Review of Pathological Image AI Analysis Software" provides essential guidelines for the evaluation of AI software in pathology, covering data collection, algorithm performance, and safety standards to ensure the reliability and effectiveness of AI diagnostics tools.
Read MoreChina Announces the Release of 20 New Medical Device Industry Standards
On February 19, 2024, the National Medical Products Administration (NMPA) of China announced the release and implementation of 20 revised and new standards for medical devices, aimed at enhancing product quality, safety, and regulatory compliance across a broad spectrum of medical technologies.
Read More