New medical device industry standards approved in June 2023 by the National Medical Products Administration (NMPA) consist of 7 mandatory industry standards and 13 recommended industry standards, and will come into effect from July 1, 2025, onwards. In this blog post, we will provide a breakdown of these 20 key standards in total that have been announced by the NMPA on June 28, 2023.
Mandatory Industry Standards for Medical Devices:
- YY 0272-2023: Dental Science – Zinc oxide/eugenol cement and eugenol-free zinc oxide cement
- YY 0503-2023: Ethylene Oxide Sterilizer
- YY 0793.3-2023: Preparation and Quality Management of Fluids for Hemodialysis and Related Therapies – Part 3: Concentrates for Hemodialysis and Related Therapies
- YY 0989.3-2023: Surgical Implants – Active Implantable Medical Devices – Part 3: Implantable Neurostimulators
- YY 1881-2023: Medical Positive Airway Respirator
- YY 1885-2023: Negative Pressure Isolation Chamber for Transporting Patients with Infectious Diseases
- YY 1887-2023: Medical Positive Pressure Suits
Recommended Industry Standards for Medical Devices
- YY/T 0338-2023: Tracheotomy Cannulae and Connectors
- YY/T 0776-2023: Radiofrequency Ablation of the Liver
- YY/T 0907-2023: Medical Needleless Syringes – Requirements and Test Methods
- YY/T 0992-2023: Endoscopic Cleaning Workstation
- YY/T 1437-2023: Medical Devices – GB/T 42062 Application Guide
- YY/T 1754.3-2023: Preclinical Animal Studies for Medical Devices – Part 3: Animal Models of Incisional Hernia of the Abdominal Wall for the Evaluation of Histological Response and Biomechanical Properties of Patches
- YY/T 1766.3-2023: Methods for Evaluating the Image Quality of X-ray Computed Tomography Equipment – Part 3: Dual Energy Imaging and Performance Evaluation of Energy Spectrum Applications
- YY/T 1873-2023: Anesthetic and Respiratory Equipment – Laughing Gas Inhalation Sedation and Analgesia Devices
- YY/T 1884-2023: Fixed Copper IUDs
- YY/T 1894-2023: Methodology for Validation of Reliability Indicators for Medical Magnetic Resonance Equipment
- YY/T 1896-2023: Method of Defining the Wavelength Range of Spectral Radiation Therapy Equipment
- YY/T 1897-2023: Biological Evaluation of Nanomedical Devices – Genotoxicity Test – In Vitro Mammalian Cell Micronucleus Test
- YY/T 1899-2023: Method for the Preparation and Evaluation of Histopathological Samples after Implantation of Resorbable Medical Devices
Further information
Read the original NMPA announcement on the 20 newly approved medical device industry standards in June 2023.
If you want to know more about their scope and implications for the medical device industry, please reach out to your Cisema consultant for further advice. Discover our services for medical device registration, renewals and NMPA Legal Agent.
