China Tightens Medical Device Classification Rules to Enhance Safety and Efficiency
The National Medical Products Administration has issued Announcement No. 59 of 2024 to improve the classification management of medical devices. The announcement details the procedures for classifying medical devices based on regulations and guidelines, focusing on factors like intended use and risks. It covers classification for new devices, uncertain categories, and emergency situations during public health crises. The implementation begins on September 1, 2024, replacing the previous classification notification.
Read MoreRegulatory Requirements for Medical Device Manufacturing and Distribution Under the New IVD Classification Catalogue
The National Medical Products Administration (NMPA) of China has released new guidelines under the "In Vitro Diagnostic Reagent Classification Catalogue" to update the regulatory framework for the manufacturing and distribution of medical devices. These guidelines necessitate that manufacturers and distributors of in vitro diagnostic reagents adhere to specific licensing and registration processes based on the management categories detailed in their product registration certificates. The NMPA has mandated continued use of the classification "Management Category - 6840 In Vitro Diagnostic Reagents" across various scopes of manufacturing and distribution. Additionally, provincial drug regulatory authorities are instructed to facilitate the training and implementation of these new regulations to ensure compliance and enhance the management of medical devices, particularly focusing on in vitro diagnostic reagents. This initiative is part of the NMPA’s broader efforts to streamline and improve regulatory processes within the medical device sector in China.
Read MoreMore Insights into China's Updated Classification Guidelines for In Vitro Diagnostic Reagents
China's NMPA introduced significant updates to the management and classification of in vitro diagnostic reagents. These updates include maintaining the validity of existing registrations approved before this date and requiring new registration applications to comply with a revised classification catalogue. The changes also address category adjustments, where products must re-register under the new or old categories depending on risk level adjustments. Additionally, the NMPA will continue processing renewal and change applications received before the effective date under the old catalogue. Class I in vitro diagnostic reagents have a specific transition period until June 30, 2024, after which they must comply with the new catalogue. These revisions aim to enhance the regulatory framework, ensuring the safety and efficacy of in vitro diagnostic reagents in line with current standards.
Read MoreChina's NMPA Issues New Guidelines for In Vitro Diagnostic Reagent Classification
The National Medical Products Administration (NMPA) of China has released Notification No. 17 of 2024, introducing the "Catalogue of In Vitro Diagnostic Reagent Classification." This initiative is designed to streamline the classification process for in vitro diagnostic reagents as per the "Regulations on the Supervision and Management of Medical Devices" and other related guidelines. The Catalogue delineates the scope and structure of these reagents, excluding those used for legally mandated blood screening and those labeled with radioactive isotopes, and organizes them into a detailed system of 25 first-level and 1,852 second-level categories based on detection targets. It provides a pathway for the management of new products, allowing for direct Class III registration or category determination under the Classification Rules. The notification also specifies the management of various products including culture and cell culture media, and general reagents. Moreover, it announces the repeal of previous related notices, effective January 1, 2025, and highlights the dynamic adjustment of the Catalogue based on ongoing risk analysis and device evaluation. This systematic update aims to ensure regulatory compliance and facilitate the registration and filing processes for in vitro diagnostic reagents.
Read MoreNMPA Approves Registration of 292 Medical Device Products in April 2024
In April 2024, China's National Medical Products Administration (NMPA) approved 292 medical device products, including various innovative devices such as single-use surgical instruments, advanced diagnostic kits, and therapeutic devices from notable companies like Volcano AtheroMed Inc., Integra LifeSciences, and Abbott Medical. These approvals span across domestic and imported devices, highlighting the NMPA's focus on expanding access to advanced medical technologies.
Read MoreRecent Enforcement Actions in China’s Medical Device Sector Highlight Regulatory Compliance
The National Medical Products Administration of China has unveiled six significant cases of regulatory violations within the medical device sector, emphasizing its dedication to enforcing stringent safety and legality standards. These instances involve various infractions, including the production and distribution of unregistered and expired medical devices, discrepancies in manufacturer information, and submission of falsified documents. Notable cases include Shanghai Youya Pharmaceutical Technology Co., Ltd., which faced hefty fines and confiscation of illegal gains for unauthorized production, and Chongqing Hexi Medical Beauty Clinic, which incurred a major penalty for using non-compliant Class III medical devices. These actions reflect China's proactive approach to ensuring compliance in the medical device industry, aiming to safeguard public health through rigorous regulatory oversight.
Read MoreExploring the Role of Commercial Insurance in Facilitating Access to Innovative Medical Products in China
Commercial insurance is playing a pivotal role in advancing healthcare access in China, particularly in regions like Hainan and the Greater Bay Area. By covering high costs associated with innovative medical products, insurance is making these treatments more accessible and affordable for patients. This not only aids in quick market entry and expansion for international medical products but also aligns with China's healthcare policies promoting innovation. In areas like the Boao Lecheng International Medical Tourism Pilot Zone in Hainan and the Greater Bay Area, commercial insurance is fostering the creation of international medical hubs, enhancing patient care, and facilitating the integration of cutting-edge medical technologies. This strategic use of insurance supports the broader vision of a modernized, patient-centered healthcare system in China.
Read MoreGuangdong 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.
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