Thirty-six medical devices standards will take effect in July 2025, including three national standards for cardiovascular implants. These newly established or revised standards are aimed to facilitate manufacturers with local type testing and regulatory submission and make them more consistent with the international counterparts.
Legally Binding
Mandatory Standards are legally enforced. Decree 739 Regulation on Supervision and Management of Medical Devices, the highest law governing medical device industry in China, mandates that “medical device shall meet the national mandatory standards; if there are no national mandatory standards, they shall comply with the industry mandatory standards”.
The recommended standards are not legally binding but recommended by regulatory authorities.
For English version of the Decree 739 Regulation on Supervision and Management of Medical Devices, please email info@ChinaMedDevice.com.
Huge Impact
Whether you are renewing or submitting new registration, your medical devices need to meet these new standards. Even if your renewals (every 5 years required by NMPA) have no changes, you still have to prove that your originally approved products can meet the new standards. As a result, your originally approved products will still need to go through local type testing to show that you are current with the new standards. China Med Device, LLC has test engineers at NMPA testing centers to help you assess and expedite your type testing needs and shorten your renewal or new approval time.
Standards by Indications
The 36 standards are categorized by the following indications:
Cardiovascular
- GB/T 44138-2024 Cardiovascular Implants — Absorbable Implants
- GB/T 12279.1-2024 Cardiovascular Implants — Artificial Heart Valves — Part 1: General Requirements
- GB/T 12279.2-2024 Cardiovascular Implants — Artificial Heart Valves — Part 2: Surgical Implantable Heart Valves
Chemistry
- YY/T 1550.3-2024 Guidance for Compatibility Study of Infusion Devices with Drugs — Part 3: Extractables Study
Dental
- YY 0272-2023 Dentistry — Zinc Oxide/Eugenol Cement and Zinc Oxide Cement Without Eugenol
- YY/T 1932-2024 Dentistry — Aligner Orthodontic Appliances Without Brackets
- YY/T 1936-2024 Customized Fixed Dental Prostheses
- YY/T 1937-2024 Customized Removable Dental Prostheses
Gastroenterology and Urology
- YY/T 1148-2024 Lumbar Puncture Needle
General and Plastic Surgery
- YY 0167-2020/XG1-2024 Amendment No.1 to “Non-Absorbable Surgical Suture”
- YY 1116-2020/XG1-2024 Amendment No.1 to “Absorbable Surgical Suture”
- YY/T 1754.4-2024 Preclinical Animal Studies — Acute Wound Model for Evaluating Wound Dressing Healing
- YY/T 0282-2024 Hypodermic Needles
- YY/T 1306-2024 Fumigation Therapy Equipment
General Hospital
- GB/T 43952-2024 Medical Supply Units
- GB/T 44059.1-2024 Medical Gas Pipeline Systems — Part 1
- GB 19082-2023E Disposable Medical Protective Clothing
- YY/T 1942-2024 Structure and Content of Unique Device Identification (UDI)
- YY/T 1943-2024 Packaging Implementation and Application of UDI
- YY/T 0923-2024 Test Method for Microbial Ingress Through Liquid and Blood Pathway Connectors
- YY/T 0063-2024 Medical Electrical Equipment — Diagnostic X-ray Tube Assemblies
- YY/T 1307-2024 Digital Mammography Detectors
- YY/T 1117-2024 Plaster Bandages
- YY 0503-2023 Ethylene Oxide Sterilizers
Hematology
- YY 0793.3-2023 Preparation and Quality Management of Fluids for Hemodialysis and Related Therapies — Part 3: Concentrates
Immunology
- YY/T 1786-2024 Hepatitis B Virus e Antigen Detection Kit (Chemiluminescent Immunoassay)
Microbiology
- YY/T 0923-2024 Test Method for Microbial Ingress Through Liquid and Blood Pathway Connectors
- YY 0503-2023 Ethylene Oxide Sterilizers
Obstetrical and Gynecological
- YY/T 1535-2024 Medical Devices for Assisted Reproductive Technology — Human Sperm Survival Test
Orthopedic
- YY/T 0810.1-2024 Joint Replacement Implants — Tibial Tray Fatigue Testing
- YY/T 0924.2-2024 Joint Replacement Implants — Articulating Surfaces
- YY/T 1922-2024 Sports Medicine Implants — Tendon and Ligament Fixation Screws
Pathology
- YY/T 0870.8-2024 Tests for Genotoxicity — In Vivo Unscheduled DNA Synthesis Assay
- YY/T 1550.3-2024 Extractables Study
Physical Medicine
- YY/T 1306-2024 Fumigation Therapy Equipment
- YY/T 1117-2024 Plaster Bandages
Radiology
- YY/T 0063-2024 Medical X-ray Tube Assemblies
- YY/T 1307-2024 Digital Mammography Detectors
- YY/T 1933-2024 Technical Specification for MRI Contrast Injectors
Toxicology
- YY/T 0870.8-2024 Genotoxicity Testing — DNA Synthesis Assay
- YY/T 1550.3-2024 Compatibility and Unknown Extractables
Molecular Diagnostics
- YY/T 1786-2024 Hepatitis B Virus e Antigen Detection Kit (Chemiluminescent Immunoassay)
Protective Equipment
- GB 19082-2023E Disposable Medical Protective Clothing
- YY 1881-2023 Medical Positive Pressure Respirator
- YY 1887-2023 Medical Positive Pressure Protective Clothing
- YY 1885-2023 Negative Pressure Isolation Transport Chamber