MEDTECH NEWS

On February 28, 2026, China's NMPA Center for Medical Device Evaluation (CMDE) released Announcement No. 8, introducing new registration review guidance for the reliability evaluation of CT X-ray tube assemblies. The guidance establishes standardized requirements for manufacturers to define and validate a reliability index — covering service life, confidence levels, and scan capacity — through either verification or determination-based testing approaches, including both normal-condition and accelerated life testing. It also mandates Failure Mode, Effects, and Criticality Analysis (FMECA), performance testing across key parameters such as focal spot size, radiation dose, and image quality, and proper documentation in the registration dossier. Applicable to both standalone tube assembly registrations and those submitted as part of a complete CT system, this guidance signals China's continued drive to align its medical device regulatory standards with international benchmarks, and serves as essential reading for domestic and global manufacturers navigating NMPA market entry for CT-related products.

China's NMPA Center for Medical Device Evaluation has released revised registration guidelines for endotracheal tube products on January 9, 2026. The 2026 edition applies to Class II passive endotracheal tubes and establishes comprehensive requirements across regulatory documentation, technical specifications, non-clinical research, and labeling. Key provisions include mandatory risk management per GB/T 42062 standards, biocompatibility testing, sterilization validation with SAL of 1×10⁻⁶, and special labeling requirements for DEHP-containing PVC products. While endotracheal tubes remain exempt from clinical evaluation requirements, manufacturers must demonstrate product equivalence unless involving new materials or mechanisms.

China's National Medical Products Administration (NMPA) has launched a comprehensive public consultation on 26 medical device registration guidelines, announced on December 11, 2025. The consultation includes two guidelines requiring higher-level review: a newly drafted guideline on glaucoma drainage devices for minimally invasive glaucoma surgery (MIGS) implantation and a 2025 revised version of the central venous catheter registration guideline. Additionally, 24 Class II medical device registration guidelines are open for comment, covering products such as anesthesia reservoir bags, implantable contraceptive devices, coronary guidewires, acupuncture needles, glass infusion containers, disposable syringes, hemoglobin testing reagents, nasal airways, umbilical cord clamps, bone scissors, collagen dressings, suction heads, disposable protective clothing, and various catheter-based devices. Stakeholders are invited to submit feedback by January 9-10, 2026, depending on the specific guideline. This initiative reflects NMPA's systematic effort to update and strengthen regulatory frameworks for medical device registration and evaluation across multiple product categories.

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.

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.

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.

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.

China’s National Medical Products Administration released revised guidelines for mobile medical device registration (2025). The new document clarifies technical requirements, risk management, and cybersecurity standards for handheld, wearable, and software devices, aiming to ensure safety and regulatory consistency as mobile healthcare technologies advance. The rules take effect immediately.

China's 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.

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.

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.

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.

China's National Medical Products Administration announced 34 new medical device industry standards on October 8, 2024. These standards cover various areas including dental materials, blood purification equipment, ophthalmology instruments, surgical implants, AI in medical devices, robotic surgical systems, genetic testing kits, and tissue engineering materials. The standards aim to regulate performance, safety, and quality requirements, reflecting technological advancements in China's medical device industry. Implementation dates range from 2025 to 2027.

On July 8, 2024, the National Medical Products Administration (NMPA) announced amendments to the YY 0167-2020 and YY 1116-2020 standards for non-absorbable and absorbable surgical sutures, respectively. Effective 12 months from approval on July 1, 2024, these updates aim to enhance the quality and safety of surgical sutures, aligning with both current medical needs and international standards.

On May 27, 2024, the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA) released 48 new guidelines for the registration review of various medical devices, including electric photography beds. The guidelines cover a wide range of medical device categories, such as diagnostic equipment, therapeutic devices, auxiliary equipment, rehabilitation tools, and in vitro diagnostic reagents. These guidelines aim to standardize the registration process, enhance industry standards, and ensure the safety and effectiveness of medical devices. Detailed guidelines for specific devices, including medical gas alarm systems, air-oxygen blenders, radiotherapy laser positioning devices, and various testing reagents, are provided to support manufacturers in meeting regulatory standards. The full texts of these guidelines are available on the NMPA's official CMDE website.

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.

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.

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.

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.

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.

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.

In 2023, China significantly advanced its medical device industry by approving and publishing a wide range of national and industry standards, establishing key standardization technical organizations, and reinforcing its commitment to safety, innovation, and global competitiveness.

The "Key Points for the Performance Evaluation Review of Pathological Image AI Analysis Software" provides essential guidelines for the evaluation of AI software in pathology, covering data collection, algorithm performance, and safety standards to ensure the reliability and effectiveness of AI diagnostics tools.

On February 19, 2024, the National Medical Products Administration (NMPA) of China announced the release and implementation of 20 revised and new standards for medical devices, aimed at enhancing product quality, safety, and regulatory compliance across a broad spectrum of medical technologies.

The "Guidance on Real-World Study Design and Statistical Analysis for Medical Device Registration Review" issued by the NMPA and CMDE on January 10, 2024, revolutionizes the use of real-world data in China's medical device clinical evaluations, enhancing device safety and efficacy assessments in real-life applications.