Guangdong Leads the Way in Real-World Medical Research with Innovative "Guangdong-Hong Kong-Macao Greater Bay Area (GBA) Medical Pass
The Guangdong Provincial Drug Administration has launched the "Guangdong-Hong Kong-Macao Greater Bay Area (GBA) Medical Pass," a pioneering policy initiative aimed at enhancing real-world medical research within the region. This policy facilitates the use of cutting-edge, clinically urgent medical products in designated institutions, thereby accelerating the approval processes and integrating real-world evidence into regulatory assessments. The initiative was highlighted through the introduction of the PROEM study at a conference in Guangzhou, focusing on the real-world efficacy and safety of Lemborexant in treating insomnia. The robust biopharmaceutical infrastructure in Guangdong supports a range from basic research to clinical applications, underpinning the region's leadership in drug and medical device innovation. As of March 2024, significant progress has been made with 19 institutions approved to participate and 59 types of medical products sanctioned for use, benefiting over 5,000 patients. Looking forward, Guangdong aims to further consolidate its role as a global biopharmaceutical hub by leveraging its industrial strengths and integrating resources across the GBA. This initiative not only underscores the region's commitment to scientific advancement and patient care but also sets a precedent for regulatory innovation in medical research across China.
Read MoreInterpretation of the Guidelines for the Review of Usability Engineering in Medical Device Registration
The interpretation of "Guidelines for the Review of Usability Engineering in Medical Device Registration," published on March 27, 2024, are designed to enhance the usability requirements for Class II and Class III medical devices in China. These guidelines emphasize the critical role of human-machine interaction in medical device design, focusing on ensuring safety, effectiveness, and ease of use through comprehensive usability engineering. They specify processes for usability engineering lifecycle quality control, detail the verification and confirmation of user interfaces, and address the unique challenges associated with imported devices. Additionally, the guidelines discuss how usability engineering relates to clinical trials, the evaluation of existing user interfaces, and the specific considerations for devices used in combination. Application instructions for medical device registration under these guidelines include the submission of usability engineering research reports or use error evaluation reports, depending on the device's risk level. This initiative aims to align China's regulatory standards with international practices, thereby enhancing its global regulatory influence.
Read MoreNMPA Announcement on Further Strengthening the Supervision and Management of Medical Device Registrants' Contract Manufacturing
On April 2, 2024, China's National Medical Products Administration (NMPA) introduced new guidelines to improve oversight of contract manufacturing in the medical device sector. These measures aim to ensure quality and safety by mandating registrants to maintain robust quality management systems, select capable contract manufacturers, and closely monitor the entire lifecycle of medical devices. Key aspects include the requirement for quality agreements, annual reviews, and stringent oversight by regulatory bodies. The initiative emphasizes collaboration between registrants and manufacturers, enhanced regulatory supervision, and the use of technology for efficient oversight. Set to be implemented on June 1, 2024, these guidelines mark a significant step towards ensuring the integrity and safety of medical devices produced through contract manufacturing.
Read MoreChina'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.
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