NMPA issued the “2025 Medical Device Industry Standards Revisions Plan” on February 24, 2025. Six mandatory and seventy-nine recommended standards will be revised or established. The Standards Revisions are aimed to facilitate manufacturers with local type testing and regulatory submission and make standards more consistent with the international standards.
Legally Binding
Industry Mandatory Standardsare 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 industry 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.
Standards by Indications
The 85 standards are categorized by the following indications: Anesthesiology; Cardiovascular; Chemistry; Dental; Ear, Nose, and Throat; Gastroenterology and Urology; General and Plastic Surgery; General Hospital; Hematology; Immunology; Microbiology; Neurology; Obstetrical and Gynecological; Ophthalmic; Orthopedic; Pathology; Physical Medicine; Radiology; Toxicology; Molecular Diagnostics.
Anesthesiology
- YY 0600.4—2013 Anesthesia and Respiratory Equipment – Manual Resuscitator
- YY/T 0978—2016 Anesthesia and Respiratory Equipment – Anesthesia Reservoir Bag
- YY/T 0985—2016 Anesthesia and Respiratory Equipment – Supraglottic Airway and Connector
- Anesthesia Machine and Ventilator Internal Circuit Disinfector
Cardiovascular
- YY 1048—2016 Cardiopulmonary Bypass System – Extracorporeal Circulation Tubing
- YY 0604—2016 Cardiopulmonary Bypass System – Blood Gas Exchanger (Oxygenator)
- YY/T 1565—2017 Surgical Implants – Nondestructive Testing – Radiographic Testing for Cast Metal Surgical Implants
- Cardiac Pulsed Electric Field Ablation Instrument
- Intravascular Radiofrequency Ablation Device
- Cardiovascular Implants – Intravascular Devices – Part 4: Application of YY/T 1860.1 to Coated Intravascular Devices
Chemistry
- Cortisol Assay Kit
- Blood Ammonia Assay Kit
- YY/T 1230—2014 Cystatin C Assay Kit
- YY/T 0495—2009 Dentistry – Root Canal Filling Materials
- YY/T 0624—2016 Dentistry – Orthodontic Elastomeric Attachments
- Dialysate Filter
Dental
- YY/T 0803.2—2020 Dentistry – Endodontic Instruments – Part 2: Enlargers
- YY/T 0803.4—2015 Dentistry – Endodontic Instruments – Part 4: Auxiliary Instruments
- Dentistry – Portable Dental Equipment for Non-Permanent Medical Settings – Part 3: Portable Suction Equipment
- Dentistry – Rotational Adaptability Test for Implant-Abutment Connections
- YY/T 0496—2016 Dentistry – Casting Wax and Baseplate Wax
- Dentistry – Machinable Polymer-Based Composite Blocks
- Preclinical Animal Study for Dental Medical Devices – Bone Integration Evaluation of Implants
Ear, Nose, and Throat
- Intravascular Shockwave Therapy Equipment
- Mobile Magnetic Resonance Imaging Equipment – Safety Test Methods
Gastroenterology and Urology
- Digestive Tract pH Measurement and Analysis Equipment
- Single-Use Peritoneal Dialysis Catheter
- Single-Use Lacrimal Drainage Tube
General and Plastic Surgery
- Surgical Implants – Nondestructive Testing – Radiographic Testing for Cast Metal Surgical Implants
- General Requirements for Associated Devices for Passive Surgical Implants
- Surgical Instruments – Circular Staplers and Components
- Preclinical Animal Study for Dental Medical Devices – Bone Integration Evaluation of Implants
General Hospital
- Medical Devices for Assisted Human Reproduction – Mouse Single-Blastocyst RNA-Seq Test
- Medical Additive Manufacturing – Process Control and Validation Requirements for Metal Powder Bed Laser Melting
- Medical Device Reproductive and Developmental Toxicity Test – Part 5: Extended One-Generation Reproductive Toxicity Test
- Medical Device Genotoxicity Test – Part 9: Pig-a Gene Mutation Test in Mammalian Red Blood Cells
- Medical Device Hemolysis Test – Part 2: Mechanical Force-Mediated Hemolysis Test
- Medical Device Carcinogenicity Test – Part 1: In Vitro Cell Transformation Test
Hematology
- Hepatitis C Virus Nucleic Acid Detection Kit
- Irregular Human Erythrocyte Antibody Detection Kit
- KRAS Gene Mutation Detection Kit (Fluorescence PCR Method)
- Human Red Blood Cell Irregular Antibody Detection Kit
- Medical Device Reproductive and Developmental Toxicity Test – Part 5: Extended One-Generation Reproductive Toxicity Test
Immunology
- Mycoplasma Pneumoniae Nucleic Acid Detection Kit
- Hepatitis B Virus Nucleic Acid Quantification Kit
- ALK Fusion/Rearrangement Gene Detection Kit (Fluorescence In Situ Hybridization Method)
- Medical Devices for Assisted Human Reproduction – Mouse Single-Blastocyst RNA-Seq Test
- Cytokine Assay Kit
Microbiology
- Mycoplasma Pneumoniae Nucleic Acid Detection Kit
- Chromosomal Aneuploidy and Gene Copy Number Variation Detection Kit (High-Throughput Sequencing Method)
- Cystatin C Assay Kit
Neurology
- Artificial Intelligence Medical Devices – Fracture CT Imaging-Assisted Analysis Software – Algorithm Performance Test Methods
- Artificial Intelligence Medical Devices – X-ray Imaging Bone Age Assessment Software – Algorithm Performance Test Methods
- Robot-Assisted Remote Ultrasound Diagnosis System
- Robot-Assisted Puncture Surgery Navigation Equipment
Obstetrical and Gynecological
- Fallopian Tube Catheter
- Medical Platelet Storage Cabinet
Ophthalmic
- Ophthalmic Optics – Intraocular Lenses – Part 10: Phakic Intraocular Lenses
- Eye Care Optical – Artificial Crystalline Lenses
Orthopedic
- Orthopedic Implants for Spinal Surgery
- Orthopedic Implants for Hip Joint Replacement
Pathology
- Medical Device Reproductive and Developmental Toxicity Test – Part 5: Extended One-Generation Reproductive Toxicity Test
Physical Medicine
- Mobile Magnetic Resonance Imaging Equipment – Safety Test Methods
- Non-Invasive Blood Pressure Monitor – Clinical Study for Automatic Continuous Measurement Type
- Cardiac Pulsed Electric Field Ablation Instrument
Radiology
- YY/T 0744—2018 Special Technical Requirements for Mobile C-arm X-ray Machine
- YY/T 0706—2017 Special Technical Requirements for Mammography X-ray Machine
- YY/T 0906—2013 Performance Test Methods for B-mode Ultrasonic Diagnostic Equipment with Endocavitary Probes
Toxicology
- Genotoxicity Test for Medical Devices – Pig-a Gene Mutation Test in Mammalian Red Blood Cells
- Carcinogenicity Test for Medical Devices – In Vitro Cell Transformation Test
Molecular Diagnostics
- High-Throughput Sequencing Method for Chromosomal Aneuploidy and Gene Copy Number Variation Detection Kit
- KRAS Gene Mutation Detection Kit (Fluorescence PCR Method)
- Gene Mutation Detection Kit (Fluorescence In Situ Hybridization Method)
- Medical Devices for Assisted Human Reproduction – Mouse Single-Blastocyst RNA-Seq Test
- Tumor Gene Variation Detection Based on RNA Capture Sequencing
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.