Thirty four industry standards for medical devices were issued by the NMPA on October 22, 2020. These were put in place to guide manufacturers for local type testing, clinical trials, and regulatory approval. The standards cover indications of orthopedic, cardiovascular, general hospital, and so on.
NMPA Standards for October 2020
Surveillance for orthopedic products is becoming more and more stringent in China considering nearly 20% of the standards are related to orthopedics. China Med Device, LLC can help you evaluate the gap between your products and China guidelines or standards.
General Standard
- YY/T 0664-2020 Medical device software lifecycle process
- YY/T 1754.1-2020 Preclinical animal research for medical devices Part 1: General Requirements
- YY/T 1737-2020 Analysis of bioload control level of medical devices
- YY/T 1738-2020 Energy consumption measurement method for medical electrical equipment
- YY/T 1759-2020 Guidance for medical devices soft primary packaging design and evaluation
General Hospital
- Medical electrical devices Part 2-41: Particular requirements for the safety of surgical shadowless light and diagnostic light
- Disposable intravenous nutrition infusion bag
- Medical gloves for single use-Part 7: Test method for the immunological measurement of antigenic protein
Orthopedic
- Non-active surgical implants Osteosynthesis and spinal implants – Part 1: Special requirements for osteosynthesis implants
- Non-active surgical implants Osteosynthesis and spinal implants – Part 2: Special requirements for spinal implants
- Implants for surgery-determination of bending strength and stiffness of bone plates
- Implant for surgery——Wear of total hip-joint prostheses–Part 2: Methods of measurement
- Implants for surgery—Partial and total hip joint prostheses—Part 2: Articulating surfaces made of metallic, ceramic and plastics materials
- Cutting tools for electric osseous tissue surgical equipment—Part 4: Milling cutter
- Cutting tools for electric osseous tissue surgical equipment—Part 5: Saw blade
Cardiovascular
- Sterile, single-use intravascular catheters – Part 6: Subcutaneous implantable drug delivery device
- Cardiovascular implant—— Pulmonary artery valve duct
The 34 standards also include those for radiology, clinical chemistry, and hematology.
For an English version of any standard listed above or the completed list of all of the 34 standards, please email us at info@ChinaMedDevice.com.
We can also help you deliver opinions directly to the NMPA for the draft standards.