China Med Device, LLC joined the NMPA Session on interpreting the “Notice of Medical Device Submission Material Requirements and Certificate Format” held on December 16, 2021.
China Med Device summarizes the key points in the session as follows:
Equivalence to nIVDMA ToC
The file structure is basically the same as the nIVDMA ToC. It made clear regulations on electrical safety, radiation safety, usability, and non-clinical literature research.
Basic Principles of Medical Device Safety and Performance
The document incorporated the “Basic Principles of Medical Device Safety and Performance” to enhance the evaluation system. The basic principles stipulate the basic design and production requirements to achieve the expected safety and performance of the product. The basic principles are the important basis for the design and development, production technology, performance requirements, system construction of the production enterprise, and the pre-market review and post-market reassessment by the regulatory authorities.
The requirement to submit a pre-evaluation opinion issued by a medical device inspection agency has been deleted. Applicants can submit the self-testing report instead.
The product shall comply with the applicable mandatory standards. If the structure features, intended use, usage methods, etc. are inconsistent with the those in the mandatory standard, the applicant should provide an explanation of the non-applicability.
Non-clinical research and modeling research
Applicants shall provide a summary of non-clinical research to outline the research methods and research conclusions. Each research can be carried out through literature research, laboratory research, model research, etc., and generally should include research plans and research reports. If modeling research is used, product modeling research data should be provided.
Research materials on electrical safety, machinery and environmental protection, and electromagnetic compatibility should be provided, indicating the applicable standards and the research carried out.
X-ray, a, B, y, neutron and other particle radiation, microwave radiation, laser, infrared radiation, ultraviolet radiation, and other visible electromagnetic radiation shall be analyzed.
Biological characteristics study
special considerations shall be paid on pollutants, precipitates (including leachate and/or evaporates), degradation products, processing residues, absorbable products, nanomaterials, etc.
Dose-effect relationship and energy safety
For medical devices that provide energy or material therapy to patients, the dose-effect relationship and energy safety research data should be provided to prove the safety, effectiveness, and rationality of the treatment parameter settings, and the energy is not available except for the expected target tissue.
1) Periodic treatment equipment, treatment frequency and cycle should also be considered
2) Because clinical data cannot traverse all treatment parameters, it is usually not a substitute for dose-effect relationship research
3) Can be combined with the basis for determining performance parameters
4) A single treatment parameter should also explain the rationality of its parameter setting and provide supporting data.
The guideline also stipulates submission materials requirements on software research materials, cybersecurity, sterilization, animal testing, literature research, expiration date, packaging, single-use medical devices, etc. For NMPA officials’ insights on the matters above please contact us at info@ChinaMedDevice.com.