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.
The plan includes manufacturing methods, performance testing standards, biological evaluation, non-clinical standards and quality systems of the 86 medical devices and IVDs.
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.
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
- 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 Optics, Intraocular Lens Part 8: Basic Requirements
The plan lists 77 industry recommended standards:
- Artificial intelligence medical device quality requirements and evaluation Part 2: Terminology
- Artificial intelligence medical device quality requirements and evaluation Part 1: General requirements for data sets
- Medical additive manufacturing, powder bed melt forming process, metal powder cleaning and cleaning effect verification method
- Anti-human globulin detection card (column agglutination method)
- Test kit for Treponema pallidum antibody (immunochromatography)
- EB virus nucleic acid detection kit (fluorescence PCR method)
- Respiratory virus multiple nucleic acid detection kit
- Anti-nuclear antibody spectrum IgG detection kit (immunoblotting method)
- Thyroglobulin Assay Kit (Chemiluminescence Immunoassay)
- Human chorionic gonadotropin (HCG) detection test paper (colloidal gold immunochromatography)
- Human leukocyte antigen (HLA) genotyping test kit
- In Vitro Diagnostic Test System Performance Evaluation Method Part 3: Detection Limit and Quantitation Limit
- Surgical implant coatings. Part 3: General requirements for mussel mucin coatings
- Surgical implants, sports medical implants, suture tensile test methods
- Bone engagement implant metal femoral neck fixation nail
- Surgical implants. Part and total hip prostheses. Part 10: Determination of combined anti-static load of femoral head
- Cardiovascular implantation equipment Nickel titanium alloy nickel ion release test method
- X-ray blood irradiation equipment
- Calculation method of body type specific dose estimation value of X-ray computer tomography equipment
- Medical general photography digital X-ray image detector
- Medical dynamic digital X-ray image detector
- Polyurethane male condoms technical requirements and test methods
- Anesthesia and respiratory equipment General requirements for airways and related equipment
- Blocking interceptor
- Endoscopic surgical instruments Repeated use of abdominal aspirator
- Basic requirements for medical electrical equipment network security
- Method for collecting and evaluating reliability information of medical electrical equipment
- General requirements for reliability technology of medical electrical equipment
- Electric operating table
For English version of the 2020 Standards Revision Plan, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
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.