China's NMPA Issues New Guidelines for Disposable Anesthesia Needles Registration Review
China's National Medical Products Administration (NMPA) has released new comprehensive registration review guidelines for disposable anesthesia needles, effective immediately as of October 11, 2025. The guidelines cover four main types of anesthesia needles classified as Class III medical devices, establishing stringent technical standards for physical performance, chemical safety, and sterility requirements. Key provisions include specific endotoxin limits, biocompatibility testing protocols, and comprehensive risk management throughout the product lifecycle. Many devices may qualify for exemption from clinical evaluation, potentially streamlining the approval process. The new regulations aim to standardize quality requirements across the industry, enhance patient safety during anesthesia procedures, and align Chinese standards with international best practices. This regulatory update reflects China's commitment to strengthening medical device oversight while providing clear pathways for manufacturers to bring safe and effective anesthesia products to market.
Read MoreChina Issues Comprehensive Guidelines for Medical Device Registration Self-Inspection
China's National Medical Products Administration (NMPA) has issued new comprehensive guidelines for medical device registration self-inspection, effective September 16, 2025. The regulations require companies to integrate self-inspection capabilities into their quality management systems, maintain qualified full-time personnel, and ensure proper equipment and facilities for testing Class II and III medical devices. Key requirements include stringent quality control procedures, comprehensive record-keeping, and compliance with Good Manufacturing Practices. Regulatory authorities will conduct oversight inspections focusing on personnel qualifications, equipment adequacy, and quality control measures. The guidelines aim to strengthen China's medical device regulatory framework while aligning with international best practices, though they do not apply to companies that outsource all testing to qualified institutions. This regulatory enhancement is expected to significantly impact how medical device manufacturers approach registration testing and quality management in the Chinese market.
Read MoreChina'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 MoreChina Introduces New Policy to Boost Domestic Production of Imported Medical Devices
China's National Medical Products Administration updated policies to facilitate domestic production of imported Class II and III medical devices on March 18, 2025. The measures simplify registration through shared materials, prioritize innovative products, and ensure quality control through system inspections. These reforms aim to attract foreign investment, streamline processes, and enhance China's medical device industry.
Read MoreChina Issues New Guidelines for Neurological Medical Service Pricing
China's National Healthcare Security Administration (NHSA) has issued new trial guidelines for neurological medical service pricing, reorganizing services into 82 basic items, 24 additional charges, and 8 expanded items. This reform enables provincial authorities to establish price benchmarks and allows local adjustments, advancing China's healthcare pricing standardization efforts.
Read More