86 NMPA Standards to be Issued in 2020: Cosmetic Surgery, Cardiovascular and More

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86 NMPA Standards to be Issued in 2020: Cosmetic Surgery, Cardiovascular and More

NMPA issued the finalized version of 2020 Medical Device Industry Standards Revision Plan on May 19, in which 86 medical devices and IVDs are affected. The Standards Revisions are aimed to facilitate manufacturers with local type testing and make standards more consistent with the international standards.

Scope

The plan includes manufacturing methods, performance testing standards, biological evaluation, non-clinical standards and quality systems of the 86 medical devices and IVDs.

Legally Binding

Industry Mandatory Standardsare legally enforced. Decree 680 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 680 Regulation on Supervision and Management of Medical Devices, please email info@ChinaMedDevice.com.

Mandatory Standards

The plan lists nine industry mandatory standards:

General & Cosmetic Surgery

  • Passive Surgical Instrument Requirements: Breast Implants
  • Medical Electrical Equipment Part 2-77: Special Requirements for Basic Safety and Performance of Auxiliary Surgical Equipment Using Robotic Technology
  • Medical Electrical Equipment Part 2-78: Special Requirements for Rehabilitation and Evaluation of the Basic Safety and Basic Performance of Medical Robots
  • Medical Electrical Equipment Part 2-56: Requirements for Basic Safety and Performance of Thermometers

Cardiovascular

  • Medical Electrical Equipment Part 2-80: Requirements for Basic Safety and Performance of Respiratory Support Equipment for Respiratory Insufficiency
  • Medical Electrical Equipment Part 2-79: Requirements for Basic Safety and Performance of Respiratory Support Equipment for Respiratory Dysfunction
  • Surgical Implants. Active Implantable Medical Devices. Part 5: Circulation Support Devices

Gastroenterology and Urology

  • Liver Radiofrequency Ablation Treatment Equipment

Ophthalmic

  • Ophthalmic Optics, Intraocular Lens Part 8: Basic Requirements

Recommended Standards

The plan lists 77 industry recommended standards:

  1. Artificial intelligence medical device quality requirements and evaluation Part 2: Terminology
  2. Artificial intelligence medical device quality requirements and evaluation Part 1: General requirements for data sets
  3. Medical additive manufacturing, powder bed melt forming process, metal powder cleaning and cleaning effect verification method
  4. Anti-human globulin detection card (column agglutination method)
  5. Test kit for Treponema pallidum antibody (immunochromatography)
  6. EB virus nucleic acid detection kit (fluorescence PCR method)
  7. Respiratory virus multiple nucleic acid detection kit
  8. Anti-nuclear antibody spectrum IgG detection kit (immunoblotting method)
  9. Thyroglobulin Assay Kit (Chemiluminescence Immunoassay)
  10. Human chorionic gonadotropin (HCG) detection test paper (colloidal gold immunochromatography)
  11. Human leukocyte antigen (HLA) genotyping test kit
  12. In Vitro Diagnostic Test System Performance Evaluation Method Part 3: Detection Limit and Quantitation Limit
  13. Surgical implant coatings. Part 3: General requirements for mussel mucin coatings
  14. Surgical implants, sports medical implants, suture tensile test methods
  15. Bone engagement implant metal femoral neck fixation nail
  16. Surgical implants. Part and total hip prostheses. Part 10: Determination of combined anti-static load of femoral head
  17. Cardiovascular implantation equipment Nickel titanium alloy nickel ion release test method
  18. X-ray blood irradiation equipment
  19. Calculation method of body type specific dose estimation value of X-ray computer tomography equipment
  20. Medical general photography digital X-ray image detector
  21. Medical dynamic digital X-ray image detector
  22. Polyurethane male condoms technical requirements and test methods
  23. Anesthesia and respiratory equipment General requirements for airways and related equipment
  24. Blocking interceptor
  25. Endoscopic surgical instruments Repeated use of abdominal aspirator
  26. Basic requirements for medical electrical equipment network security
  27. Method for collecting and evaluating reliability information of medical electrical equipment
  28. General requirements for reliability technology of medical electrical equipment
  29. Electric operating table

… …

For English version of the 2020 Standards Revision Plan, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.

Huge Impact

Revisions of more than 300 industry standards for medical devices, IVDs and quality systems could be expected by the end of 2020, as NMPA announced in February 2018. 2018 Standards Revisions impacted 99 medical devices and IVDs.

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. ChinaMed 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.