MEDTECH NEWS

China's National Medical Products Administration Center for Medical Device Evaluation (NMPA CMDE) has released comprehensive technical review guidelines for chikungunya virus nucleic acid detection reagents, effective August 28, 2025. These guidelines establish stringent requirements for Class III in vitro diagnostic products, covering analytical performance standards including precision testing, cross-reactivity studies, and detection limit determination using statistical models. Clinical evaluation must be conducted at minimum three qualified institutions in epidemiologically relevant regions, with sample sizes meeting statistical requirements for at least 90% positive/negative concordance rates. The guidelines reflect China's enhanced regulatory oversight of diagnostic products for emerging infectious diseases, requiring manufacturers to align development and registration strategies with these technical standards to ensure market compliance. This initiative strengthens guidance for medical device registration applications while addressing the critical need for accurate diagnostic tools for chikungunya fever, a mosquito-borne viral disease causing fever, joint pain, and rash.

China’s NMPA has released the 2025 catalog of in vitro diagnostic (IVD) reagents exempt from clinical trials. The updated list streamlines the registration process for IVD manufacturers, clarifies eligible products, and excludes self-testing and newborn screening reagents. The catalog takes effect immediately from its publication.

China’s National Medical Products Administration issued new guidelines for classifying next-generation sequencing (NGS) in vitro diagnostic (IVD) reagents. Effective immediately, the guidance clarifies management and registration requirements, urges proper classification, and mandates updated filings. If reclassification is required under the new Guidance, registration with the appropriate authorities is needed. Starting January 1, 2027, unregistered products may not be manufactured, imported, or sold.

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.

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.

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.