Non-Active Device

Jun 19 2019

On this page, you will find frequently asked questions regarding non-active medical device registration in China. The FAQ list is updating…

Q: In the biocompatibility evaluation study of dressing products, what should be paid attention to in the preparation of the extraction solution and the selection of the evaluation items?

Regarding the preparation of the extraction solution, the extraction time should take into account the actual clinical use time of the product. In addition, the liquid absorbable product should consider its absorption capacity. Regarding the selection of the evaluation items, the human body cumulative contact time shall be considered.

Q: For the sterilization validation report, can the applicant use the sterilization validation data of other similar products to support the declaration?

If the sterilization validation report of similar product can cover the declared product after considering the risks for materials, structural composition, primary packaging, bioburden, and etc., the applicant can use the sterilization validation report of similar product as supporting documents. However, special attention should be paid to the impact of differences on the sterilization risk. The demonstrative documents should be submitted together with the sterilization validation report.

Q: Is it necessary to submit technical documents when applying change registration for shortening shelf-life of the product?

Although the risk of decline in quality of the product is reduced after shortening the shelf-life, the applicant is advised to provide rationale and necessary supporting information when applying change registration, such as test report and verification documents for real-time stability.

Q: When the product is seeking approval outside of China, the international multi-center clinical trials included Chinese population clinical data. When submitting the registration to NMPA, is it acceptable to submit this clinical trial report/data directly without the rationale of racial differences?

Data from overseas multi-center clinical trials can be accepted as clinical evaluation documents in the process of registration in NMPA. But need to demonstrate the clinical data could prove the safety and effectiveness of the product to be used in China according to the “Technical Guiding Principles for Accepting Medical Device Overseas Clinical Trial Data”. The overseas clinical data should be recognized in accordance with ethical, legal, and scientific principles. The differences in technical review requirements, population and clinical trial conditions should be considered. The racial difference is only one of them.

Q: What kind of dossier is required to prove the hemostatic mechanism for the absorbable hemostatic products?

Applicants should submit technical or supporting documents that can prove or explain the principle of hemostasis, describe how the product affects the hemostaric process, and the advantages of the product in the hemostatic process, confirm whether the application of the hemostatic mechanism combined with product is scientific and reasonable. Collect and summarize domestic and foreign research literature that support the principle of hemostasis, and submit these scientific literature in both English and Chinese. Clarify whether products with same hemostatic principle have been marketed in domestic and overseas, and investigate whether the product can cause adverse reactions such as thrombosis, coagulopathy, and etc.

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