NMPA issued the final version of “2021 Medical Device Industry Standards Revisions Plan” on July 8, in which 77 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 of the Standards Revisions Plan
The plan includes manufacturing methods, performance testing standards, biological evaluation, non-clinical standards and quality systems of the 77 medical devices and IVDs.
Legally Binding
Industry Mandatory Standards are legally enforced. Decree 739 Regulation on Supervision and Management of Medical Devices, announced on March 18, 2021, 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.
Mandatory Standards in the Standards Revisions Plan
The final plan lists eleven industry mandatory standards, compared with seven from the draft:
- Medical positive pressure supply air respirator
- Medical positive pressure protective clothing
- Infectious disease patients transport negative pressure isolation chamber
- Medical electrical equipment-Part 2-84: Special requirements for the basic safety and basic performance of emergency ventilators
- Independent gas mixer
- Ophthalmic instruments-Intraocular illuminator-Part 2: Basic requirements and test methods for optical radiation safety
- Titanium and titanium alloy dental implants
- Thermo-frequency instrument
- Preparation and quality management of hemodialysis equipment and therapeutic fluids Part 4: Hemodialysis and related therapeutic concentrates
- Hemodialysis equipment
- Dentistry: Zinc oxide, eugenol cement and zinc oxide cement without eugenol?
Recommended Standards
The plan lists 66 industry recommended standards:
- Medical device unique identification and carrier representation
- Tissue engineering medical products Determination of DNA residues in biological materials of animal origin: Fluorescence staining method
- Tissue engineering medical products Test method for evaluating the immune response of substrates and stents: lymphocyte proliferation test
- Biological evaluation of nano-medical devices Release and characterization methods of nano-silver particles and silver ions in nano-silver dressing
- Medical devices for human assisted reproductive technology. Determination of ammonium ions in culture fluids
- Medical pure tantalum powder for additive manufacturing
- Artificial intelligence medical equipment Lung image-assisted analysis software Algorithm performance test method
- Quality requirements and evaluation of artificial intelligence medical devices Part 3: General requirements for data labeling
- General technical requirements for BRAC gene mutation detection kits and databases (high-throughput sequencing method)
- Hepatitis B virus core antibody detection kit (luminescence immunoassay)
- Treponema pallidum antibody detection kit (luminescence immunoassay)
- Rh blood group antigen test card (column agglutination method)
- Triglyceride determination kit (enzymatic method)
- In Vitro Diagnostic test system performance evaluation method part 5: analysis of specificity
- general requirements for liquid chromatography-mass spectrometry determination kits
- Infectious pathogen susceptibility test and performance evaluation of antibacterial agent susceptibility test equipment Part 1: Broth microdilution reference method for in vitro activity detection of antibacterial agents against infectious disease-related fast-growing aerobic bacteria
- D-dimer determination kit
- Serum amyloid A determination kit
- Technical requirements for digitalization of positron emission tomography imaging devices
- Detector array dose measurement system performance and test method formulation
- … …
For English version of the 2020 Standards Revision Plan, please email info@ChinaMedDevice.com. We charge nominal fees for the translation.
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 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. info@ChinaMedDevice.com
