China's NMPA CMDE Issues Technical Review Guidelines for Chikungunya Virus Nucleic Acid Detection Reagents
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.
Read MoreChina NMPA Releases 2025 Catalog of In Vitro Diagnostic Reagents Exempt from Clinical Trials
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.
Read MoreNMPA Issues Guidance on Classification of Next-Generation Sequencing IVD Reagents
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.
Read MoreChina NMPA Announces 2025 Catalogue of Medical Devices Exempt from Clinical Evaluation
China’s National Medical Products Administration (NMPA) released the 2025 catalogue of medical devices exempt from clinical evaluation, expanding the list to 1,047 types of products, with 27 new additions such as 3D-printed surgical models. The updated list took effect immediately to streamline device registration and management.
Read MoreChina Releases Revised Guidelines for Registration Review of Mobile Medical Devices
Read MoreNMPA Releases the 2025 Medical Device Industry Standards Revision Plan
The NMPA released the 2025 Medical Device Standards Plan, detailing 6 mandatory and 79 recommended standards covering AI, nanotechnology, biomaterials, and robotics. Some standards align with international benchmarks to enhance global competitiveness. The plan promotes high-quality development through collaboration among regulatory bodies, ensuring safety, innovation, and compliance.
Read MoreNMPA Announces 10 New Medical Device Industry Standards
The National Medical Products Administration (NMPA) of China has announced 10 new medical device industry standards. These standards cover various medical devices including hemodialysis systems, surgical implants, high-frequency ventilators, and in vitro diagnostic reagents. The standards will be implemented between March 2026 and March 2028, aiming to enhance medical device safety and quality control.
Read MoreChina's Medical Device Standards System Achieves Major Milestone in 2024
In 2024, China's medical device standardization system reached a significant milestone with over 2,000 active standards. The advancement reflects a transition from broad framework to detailed implementation, strengthening industry regulation and safety assurance under the "Four Strictest" requirements in healthcare management.
Read MoreChina Unveils Major Reform Plan for Pharmaceutical Industry Regulation
China's State Council has released comprehensive guidelines aimed at reforming drug and medical device regulation through 2035. The plan focuses on accelerating industry innovation, streamlining approval processes, and enhancing regulatory oversight to transform China into a global pharmaceutical powerhouse.
Read MoreChina's NMPA Releases Updated Guidelines for Class III Ultrasound Imaging Devices
China's NMPA has released updated guidelines for Class III ultrasound imaging devices. Announced on October 14, 2024, the revised document aims to standardize management of these medical devices. It covers registration requirements, safety standards, software validation, and clinical applications. The guidelines reflect current regulations and technological advancements, serving as a resource for manufacturers and reviewers.