China Medical Device Standards Catalogue 2024 update has been released

China Medical Device Standards Catalogue 2024 has been released by the National Medical Products Administration (NMPA), announcing a total of 1974 medical device standards.

The Standards Catalogue is divided into two main parts, the first of which covers quality management of medical devices, Unique Identification of Medical Devices (UDI) and medical device packaging.

The second part covers different categories such as Biological Evaluation, Electrical Devices, Disinfection and Sterilisation, Surgical Devices, Surgical Implantable Devices etc.

The Catalogue lists the standard serial number, standard number, standard name, date of publication, date of implementation, substitution relationship (applicable to standards that have been published but not yet implemented), the unit of responsibility, and the scope of application. In this article, we list the standards that will come into effect in 2024.

Serial numberStandard numberStandard nameRelease dateDate of implementationAlternate relationships (applicable to standards that have been published but not yet implemented)727YY 1045-2021Dentistry Handpieces and Motors2021-09-062024-05-01YY 1045.1-2009、YY 1045.2-2010、YY 0836-2011、YY 0837-20111228YY 9706.247-2021Medical Electrical Equipment Part 2-47: Specific requirements for basic safety and essential performance of Holter systems2021-09-062024-05-01Instead of YY 0885-20131247YY 9706.234-2021Medical Electrical Equipment Part 2-34: Specific Requirements for Basic Safety and Basic Performance of Invasive Blood Pressure Monitoring Devices2021-09-062024-05-01Instead of YY 0783-20101272YY 9706.221-2021Medical Electrical Equipment Part 2-21: Basic Safety and Basic Performance Specific Requirements for Infant Radiant Warmers2021-09-062024-05-01Instead of YY 0455-20111276YY 9706.252-2021Medical Electrical Equipment Part 2-52: Specific requirements for basic safety and essential performance of medical beds2021-09-062024-05-01YY 0571-20131279GB 9706.204-2022Medical Electrical Equipment Part 2-4: Specific requirements for basic safety and essential performance of cardiac defibrillators2022-07-132024-08-01GB 9706.8-20091417YY 9706.270-2021Medical Electrical Equipment Part 2-70: Specific Requirements for Basic Safety and Basic Performance of Sleep Apnea Treatment Devices2021-09-062024-05-01YY 0671.1-20091418YY 9706.272-2021Medical Electrical Equipment Part 2-72: Specific requirements for basic safety and essential performance of home ventilators used by patients dependent on ventilators2021-09-062024-05-01YY 0600.2-20071553GB 9706.222-2022Medical Electrical Equipment Part 2-22: Specific requirements for basic safety and essential performance of laser devices for surgical, orthopedic, therapeutic, and diagnostic use2022-03-152024-05-01GB 9706.20-2000