55 Standards Released in One Day

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nmpa guidelines for nanomaterials

The NMPA released 55 revised or newly established medical device standards on May 18, 2022, with indications ranging from cardiovascular, plastic surgery, oncology, clinical chemistry and immunology, etc. 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 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.

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 the 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.

Complete List of NMPA Medical Device Standards 2022

  • 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
  • YY/T 0296-2022 Disposable injection needle Identification color code
  • YY/T 0321.1-2022 Disposable anesthesia puncture bag
  • YY/T 0346-2022 Bone engaging implants Metal femoral neck fixation nails
  • YY/T 0593-2022 Ultrasound Transcranial Doppler Flow Analyzer
  • YY/T 0646-2022 Small pressure steam sterilizer
  • YY/T 0681.12-2022 Test methods for packaging of sterile medical devices – Part 12: Anti-rubbing resistance of soft barrier materials
  • YY/T 0719.5-2022 Ophthalmic optics-Contact lens care products-Part 5: Determination of physical compatibility between contact lenses and contact lens care products
  • YY/T 0740-2022 Special technical conditions for medical angiography X-ray machines
  • YY/T 0794-2022 Special technical conditions for image plate imaging devices for X-ray photography
  • YY/T 0795-2022 Special technical conditions for oral and maxillofacial cone beam computed tomography equipment
  • YY/T 0803.1-2022 Dentistry – Root canal instruments – Part 1: General requirements
  • YY/T 0809.10-2022 Surgical implants-Partial and total hip prostheses-Part 10: Determination of static load resistance of combined femoral head
  • YY/T 0871-2022 Ophthalmic optics – Contact lenses – Hygienic handling of multi-patient try-on contact lenses
  • YY/T 0916.3-2022 Small bore connectors for medical liquids and gases-Part 3: Connectors for gastrointestinal applications
  • YY/T 0916.6-2022 Small-bore connectors for medical liquids and gases-Part 6: Connectors for shaft applications
  • YY/T 0933-2022 Medical General Photography Digital X-ray Image Detector
  • YY/T 0934-2022 Medical dynamic digital X-ray image detector
  • YY/T 0937-2022 Technical requirements for ultrasonic tissue-mimicking phantoms
  • YY/T 0967-2022 Dentistry – Rods for rotating and reciprocating instruments
  • YY/T 1011-2022 Dentistry – Nominal diameter and designation of rotary instruments
  • YY/T 1021.1-2022 Dentistry – Extraction forceps – Part 1: General requirements
  • YY/T 1226-2022 Human papillomavirus nucleic acid (typing) detection kit
  • YY/T 1282-2022 Disposable intravenous indwelling needle
  • YY/T 1629.3-2022 Electric bone tissue surgery equipment and cutters-Part 3: Drill bits
  • YY/T 1769-2022 Medical Devices for Human Assisted Reproductive Technology Artificial Insemination Catheters
  • 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)
  • YY/T 1811-2022 Complement 4 determination kit (immunoturbidimetric method)
  • YY/T 1812-2022 Characterization of physicochemical properties of degradable biomedical metal materials
  • YY/T 1813-2022 Method for collecting and evaluating information on reliability of use of medical electrical equipment
  • YY/T 1814-2022 Surgical Implants Synthetic Nonabsorbable Mesh Hernia Repair Mesh
  • 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
  • YY/T 1816-2022 Surgical implants Synthetic non-absorbable patch Dura (spinal) membrane patch
  • YY/T 1817-2022 Thyroglobulin assay kit (chemiluminescence immunoassay)
  • YY/T 1818-2022 Dentistry-Oral Digital Impression Instrument
  • YY/T 1819-2022 Dentistry – Diaphragms for orthodontic appliances
  • YY/T 1821-2022 Calculation method of body size-specific dose estimation for X-ray computed tomography equipment
  • YY/T 1822-2022 Dentistry Mouth mirror
  • YY/T 1823-2022 Cardiovascular implants-Nitinol alloy nickel ion release test method
  • YY/T 1827.1-2022 Medical electrical equipment – Radiation dose documentation – Part 1: Structured report on radiation dose for photographic and fluoroscopic equipment
  • YY/T 1830-2022 Electro-pneumatic hemostatic device
  • YY/T 1832-2022 Sports medicine implanted devices-suture tensile test method
  • YY/T 1834-2022 X-ray blood irradiation equipment
  • YY/T 1837-2022 Medical electrical equipment General requirements for reliability
  • YY/T 1838-2022 Disposable peripheral blood collection device
  • YY/T 1839-2022 Cardiopulmonary bypass system Venous bubble trap
  • YY/T 1841-2022 Cardiac Electrophysiological Mapping System
  • YY/T 1842.1-2022 Medical devices—Connectors for medical fluid storage container delivery systems—Part 1: General requirements and general test methods
  • YY/T 1842.8-2022 Medical devices—Connectors for medical fluid storage container delivery systems—Part 8: Application of apheresis citrate anticoagulant
  • YY/T 1843-2022 Basic requirements for network security of medical electrical equipment
  • YY/T 1846-2022 Endoscopic surgical instruments Reusable abdominal aspirator
  • YY/T 1847-2022 Anti-human globulin detection card (column agglutination method)

If you have any devices that can utilize any standards above, please email us at info@ChinaMedDevice.com. We can translate it and offer our turnkey solutions for regulatory and market strategy.

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