There have been 108 standards issued by the NMPA in 2022. The revised or newly established standards are aimed to facilitate manufacturers with local type testing, pre-clinical, clinical trial, and to be more consistent with the international counterparts.
The standards involve manufacturing methods, performance testing standards, biological evaluation, non-clinical standards, and quality systems.
Industry 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 industry recommended standards are not legally binding but recommended by regulatory authorities.
Whether you are renewing or submitting the 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 need 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.
Full List of 108 Standards NMPA 2022
China Med Device has summarized 2022 NMPA standards into a table below. Contact us at info@ChinaMedDevice.com to get the English copy of any standard you are interested in. We charge nominal fees for the translation.
| Title | Status | Date |
|---|---|---|
| YY 9706.268-2022 Medical Electrical Equipment Part 2-68: Particular Requirements for Basic Safety and Basic Performance of X-ray Image-guided Radiotherapy Equipment for Electron Accelerators, Light Ion Beam Therapy Equipment and Radionuclide Beam Therapy Equipment | Final | 20-May |
| YY/T 0296-2022 Disposable Injection Needle Identification Color Code | Final | 20-May |
| YY/T 0321.1-2022 Disposable Anesthesia Puncture Bag | Final | 20-May |
| YY/T 0346-2022 Bone Engaging Implants Metal Femoral Neck Fixation Nails | Final | 20-May |
| YY/T 0593-2022 Ultrasound Transcranial Doppler Flow Analyzer | Final | 20-May |
| YY/T 0646-2022 Small Pressure Steam Sterilizer | Final | 20-May |
| YY/T 0681.12-2022 Test Methods for Packaging of Sterile Medical Devices – Part 12: Anti-rubbing Resistance of Soft Barrier Materials | Final | 20-May |
| YY/T 0719.5-2022 Ophthalmic Optics-Contact Lens Care Products-Part 5: Determination of Physical Compatibility | Final | 20-May |
| YY/T 0740-2022 Special Technical Conditions for Medical Angiography X-ray Machine | Final | 20-May |
| YY/T 0794-2022 Special Technical Conditions for Image Plate Imaging Devices for X-ray Photography | Final | 20-May |
| YY/T 0795-2022 Special Technical Conditions for Oral and Maxillofacial Cone Beam Computed Tomography Equipment | Final | 20-May |
| YY/T 0803.1-2022 Dentistry – Root Canal Instruments – Part 1: General Requirements | Final | 20-May |
| YY/T 0809.10-2022 Surgical Implants-Partial and Total Hip Prostheses-Part 10: Determination of Static Load Resistance of Combined Femoral Head | Final | 20-May |
| YY/T 0871-2022 Ophthalmic optics – Contact lenses – Hygienic handling of multi-patient try-on contact lenses | Final | 20-May |
| YY/T 0916.3-2022 Small Bore Connectors for Medical Liquids and Gases-Part 3: Connectors for Gastrointestinal Applications | Final | 20-May |
| YY/T 0916.6-2022 Small-bore Connectors for Medical liquids and Gases-Part 6: Connectors for Shaft Applications | Final | 20-May |
| YY/T 0933-2022 Medical General Photography Digital X-ray Image Detector | Final | 20-May |
| YY/T 0934-2022 Medical Dynamic Digital X-ray Image Detector | Final | 20-May |
| YY/T 0937-2022 Technical Requirements for Ultrasonic Tissue-Mimicking Phantoms | Final | 20-May |
| YY/T 0967-2022 Dentistry – Rods for Rotating and Reciprocating Instruments | Final | 20-May |
| YY/T 1011-2022 Dentistry – Nominal Diameter and Designation of Rotary Instruments | Final | 20-May |
| YY/T 1021.1-2022 Dentistry – Extraction forceps – Part 1: General Requirements | Final | 20-May |
| YY/T 1226-2022 Human Papillomavirus Nucleic Acid (typing) Detection Kit | Final | 20-May |
| YY/T 1282-2022 Disposable Intravenous Indwelling Needle | Final | 20-May |
| YY/T 1629.3-2022 Electric Bone Tissue Surgery Equipment and Cutters-Part 3: Drill Bits | Final | 20-May |
| YY/T 1769-2022 Medical Devices for Human Assisted Reproductive Technology Artificial Insemination Catheters | Final | 20-May |
| YY/T 1807-2022 Dentistry-Rapid Non-Destructive Testing of Main Components in Restorative Metal Materials-Hand-held X-ray Fluorescence Spectrometer Method (semi-quantitative method) | Final | 20-May |
| YY/T 1811-2022 Complement 4 Determination Kit (immunoturbidimetric method) | Final | 20-May |
| YY/T 1812-2022 Characterization of Physicochemical Properties of Degradable Biomedical Metal Materials | Final | 20-May |
| YY/T 1813-2022 Method for Collecting and Evaluating Information on Reliability of Use of Medical Electrical Equipment | Final | 20-May |
| YY/T 1814-2022 Surgical Implants Synthetic Nonabsorbable Mesh Hernia Repair Mesh | Final | 20-May |
| YY/T 1815-2022 Biological Evaluation of Medical Devices – Application of Threshold of Toxicological Concern (TTC) to Assess the Biocompatibility of Components of Medical Devices | Final | 20-May |
| YY/T 1816-2022 Surgical implants Synthetic Non-absorbable Patch Dura (spinal) Membrane Patch | Final | 20-May |
| YY/T 1817-2022 Thyroglobulin Assay Kit (chemiluminescence immunoassay) | Final | 20-May |
| YY/T 1818-2022 Dentistry-Oral Digital Impression Instrument | Final | 20-May |
| YY/T 1819-2022 Dentistry – Diaphragms for Orthodontic Appliances | Final | 20-May |
| YY/T 1821-2022 Calculation Method of Body Size-specific Dose Estimation for X-ray Computed Tomography Equipment | Final | 20-May |
| YY/T 1822-2022 Dentistry Mouth Mirror | Final | 20-May |
| YY/T 1823-2022 Cardiovascular Implants-Nitinol Alloy Nickel Ion Release Test Method | Final | 20-May |
| YY/T 1827.1-2022 Medical ElectricalEequipment – Radiation Dose Documentation – Part 1: Structured Report on Radiation Dose for Photographic and Fluoroscopic Equipment | Final | 20-May |
| YY/T 1830-2022 Electro-pneumatic Hemostatic Device | Final | 20-May |
| YY/T 1832-2022 Sports Medicine Implanted Devices-suture Tensile Test Method | Final | 20-May |
| YY/T 1834-2022 X-ray Blood Irradiation Equipment | Final | 20-May |
| YY/T 1837-2022 Medical electrical equipment General requirements for reliability | Final | 20-May |
| YY/T 1838-2022 Disposable Peripheral Blood Collection Device | Final | 20-May |
| YY/T 1839-2022 Cardiopulmonary Bypass System Venous Bubble Trap | Final | 20-May |
| YY/T 1841-2022 Cardiac Electrophysiological Mapping System | Final | 20-May |
| YY/T 1842.1-2022 Medical devices—Connectors for Medical Fluid Storage Container Delivery System—Part 1: General Requirements and General Test Methods | Final | 20-May |
| YY/T 1842.8-2022 Medical devices—Connectors for Medical Fluid Storage Container Delivery Systems—Part 8: Application of Apheresis Citrate Anticoagulant | Final | 20-May |
| YY/T 1843-2022 Basic Requirements for Network Security of Medical Electrical Equipment | Final | 20-May |
| YY/T 1846-2022 Endoscopic Surgical Instruments Reusable Abdominal Aspirator | Final | 20-May |
| YY/T 1847-2022 Globulin Detection Card (column agglutination method) | Final | 20-May |
| YY/T 1833.1-2022 Artificial Intelligence Medical Devices-Quality Requirements and Evaluation Part 1: Terminology | Final | 6-Jul |
| YY/T 1833.2-2022 Artificial Intelligence Medical Devices-Quality Requirements and Evaluation-Part 2: General Requirements for Data Sets | Final | 6-Jul |
| YY/T 0273-2022 Dentistry-Dental Amalgam Blender | Final | 6-Jul |
| YY/T 0290.4-2022 Ophthalmic Optics – Intraocular lenses – Part 4: Labeling and Information | Final | 6-Jul |
| YY/T 0299-2022 Medical Ultrasonic Couplant | Final | 6-Jul |
| YY/T 0482-2022 Medical Magnetic Resonance Imaging Equipment-Determination of Main Image Quality Parameters | Final | 6-Jul |
| YY/T 0519-2022 Dentistry-Testing of Bonding with Tooth Structure | Final | 6-Jul |
| YY/T 0612-2022 Disposable Human Arterial Blood Sample Collector (Arterial Blood Gas Needle) | Final | 6-Jul |
| YY/T 0634-2022 Ophthalmic Instruments Fundus Camera | Final | 6-Jul |
| YY/T 0793.1-2022 Preparation and Quality Management of Fluids for Hemodialysis and Related Treatments – Part 1: Water Treatment Device for Hemodialysis and Related Treatments | Final | 6-Jul |
| YY/T 0793.4-2022 Preparation and Quality Management of Fluids for Hemodialysis and Related Treatments- Part 4: Dialysate Quality for Hemodialysis and Related Treatments | Final | 6-Jul |
| YY/T 0821-2022 Disposable Dispensing Syringes | Final | 6-Jul |
| YY/T 1789.3-2022 In Vitro Diagnostic Test System-Performance Evaluation Method-Part 3: Detection Limit and Quantification Limit | Final | 6-Jul |
| YY/T 1789.4-2022 In Vitro Diagnostic Test System-Performance Evaluation Method-Part 4: Linear Interval and Reportable Interval | Final | 6-Jul |
| YY/T 1810-2022 Tissue Engineering Medical Products Quantitative Detection of Sulfated Glycosaminoglycans (sGAG) for Evaluating Cartilage Formation | Final | 6-Jul |
| YY/T 1835-2022 Performance and Test Methods of Breast Positron Emission Tomography Devices | Final | 6-Jul |
| YY/T 1845-2022 General Requirements for Surgical Guides for Orthopedic Surgery | Final | 6-Jul |
| YY/T 1848-2022 Disposable Ureteral Occlusion Catheter | Final | 6-Jul |
| YY/T 0325-2022 Disposable Sterile Urinary Catheter | Final | 22-Aug |
| YY/T 0334-2022 General Requirements for Silicone Rubber Surgical Implants | Final | 22-Aug |
| YY/T 0567.6-2022 Aseptic Processing of Healthcare Products – Part 6: Isolator Systems | Final | 22-Aug |
| YY/T 0642-2022 Ultrasound—Sound Field Characteristics—Test Methods for Determining the Thermal and Mechanical Index of Medical Diagnostic Ultrasound Fields | Final | 22-Aug |
| YY/T 0772.4-2022 Surgical Implants High Molecular Weight Polyethylene Part 4: Test Method for Oxidation Index | Final | 22-Aug |
| YY/T 1829-2022 Dentistry-In Vitro Evaluation Method of Dentinal Tubule Occlusion Effect | Final | 22-Aug |
| YY/T 1833.3-2022 Artificial Intelligence Medical Devices-Quality Requirements and Evaluation Part 3: General Requirements for Data Labeling | Final | 22-Aug |
| YY/T 1842.6-2022 Medical Devices-Connectors for Medical Fluid Storage Container Delivery Systems-Part 6: Neurological Applications | Final | 22-Aug |
| YY/T 1851-2022 Medical Pure Tantalum Powder for Additive Manufacturing | Final | 22-Aug |
| YY/T 1852-2022 Medical Devices for Human Assisted Reproductive Technology – Determination of Ammonium Ion in Culture Liquid | Final | 22-Aug |
| YY/T 1853-2022 Ultrasonic Bone Tissue Surgery Equipment and Tools | Final | 22-Aug |
| YY/T 1854-2022 Test Method for the Dissolution of Trioctyl Trimellitate (TOTM) in Polyvinyl Chloride Medical Devices | Final | 22-Aug |
| YY/T 1858-2022 Artificial Intelligence Medical Devices-Lung Image Aided Analysis Software-Algorithm Performance Test Method | Final | 22-Aug |
| YY/T 1864-2022 Human Factors Design Requirements and Evaluation Methods for Spinal Internal Fixation Systems and Surgical Instruments | Final | 22-Aug |
| YY/T 1872-2022 Negative Pressure Drainage Sponge | Final | 22-Aug |
| YY/T 1879-2022 Creation and Assignment of UDIs for Medical Devices | Final | 22-Aug |
| YY/T 0321.3-2022 Disposable Filters for Anesthesia | Final | 22-Aug |
| YY/T 0493-2022 Dentistry Elastomeric Impression Materials | Final | 22-Aug |
| YY 0719.2-2022 Ophthalmic Optics – Contact Lens Care Products – Part 2: Basic Requirements | Final | 17-Oct |
| YY 0290.8-2022 Ophthalmic Optics – Intraocular Lenses – Part 8: Basic Requirements | Final | 17-Oct |
| YY 0650-2022 General Technical Requirements for Radiofrequency Ablation Device | Final | 17-Oct |
| YY 1289-2022 Laser Therapy Equipment Ophthalmic Laser Photocoagulation Apparatus | Final | 17-Oct |
| YY/T 0633-2022 Ophthalmic Instruments Indirect Ophthalmoscope | Final | 17-Oct |
| YY/T 0698.2-2022 Packaging Materials for Terminally Sterilized Medical Devices – Part 2: Sterilization Packaging Materials – Requirements and Test Methods | Final | 17-Oct |
| YY/T 0719.10-2022 Ophthalmic Optics-Contact Lens Care Products-Part 10: Determination of Moisturizing Lubricants | Final | 17-Oct |
| YY/T 0952-2022 Medical Temperature Controller | Final | 17-Oct |
| YY/T 0989.5-2022 Surgical Implants Active Implantable Medical Devices Part 5: Circulatory Support Devices | Final | 17-Oct |
| YY/T 1043.1-2022 Dentistry-Non-mobile Dental Treatment Machines and Dental Patient Chairs-Part 1: General Requirements | Final | 17-Oct |
| YY/T 1293.2-2022 Contact Wound Dressings-Part 2: Polyurethane Foam Dressings | Final | 17-Oct |
| YY/T 1464-2022 Sterilization of Health Care Products – Low Temperature Steam Formaldehyde – Requirements for the Development, Validation and Routine Control of Medical Device Sterilization Processes | Final | 17-Oct |
| YY/T 1844-2022 Anesthesia and Respiratory Equipment – General Requirements for Airway and Related Equipment | Final | 17-Oct |
| YY/T 1855-2022 Test Method for Fatigue Performance of Combined Ceramic Femoral Head | Final | 17-Oct |
| YY/T 1857-2022 Dentistry Digging Spoons and Bone Curettes | Final | 17-Oct |
| YY/T 1859-2022 Anti-Calcification Evaluation of Animal-Derived Cardiovascular Implants Subcutaneous Implantation Test in Rats | Final | 17-Oct |
| YY/T 1865-2022 General Technical Requirements for BRCA Gene Mutation Detection Kits and Databases (High-throughput Sequencing Method) | Final | 17-Oct |
| YY/T 1877-2022 Method for the Determination of Bisphenol-based Propane (BPA) Residues in Extracorporeal Circulation Devices | Final | 17-Oct |
| YY/T 1880-2022 Serum Amyloid A Assay Kit | Final | 17-Oct |
| YY/T 1064-2022 Dentistry – General Requirements for Drills for Dental Implant Surgery | Final | 17-Oct |
