Q&A：How to Deal with the Coverage of Typical Models in Medical Device Registration?

Q：How to deal with the coverage of typical models in medical device registration?

A.————

1.There is no inspection coverage in the review. The so-called coverage refers to the coverage report issued by the inspection institution after checking the product difference and considering that the difference has no impact;

2.Registration regulations allow enterprises to submit descriptions of typical models in the registration process, but mainly to prove that the differences between models do not involve clinical differences (i.e. there is no need to conduct clinical trials separately);

3.According to the coordination meeting organized by the Provincial Bureau, the enterprise can apply to the testing organization for difference detection. If the catheter is only the length difference, the difference detection length (corresponding to all differences in the model and specification in part 1 of the technical requirements) can be checked on the premise of one model and specification. The review is to review the rationality and completeness of the difference detection;

4.The color difference of electronic products generally does not involve technical requirements and can be applied for. The color difference of polymer materials directly affects the material, involving other physical and chemical properties, which is difficult to pass the review. Of course, the color difference will inevitably involve the difference of biological evaluation;

5.At present, the confirmation of electromagnetic compatibility discussed with various testing institutions is as follows: the product shape affects electromagnetic shielding, which must involve electromagnetic compatibility. The risk of feedback coverage of all testing is great, and 95% of all applied products are unqualified;

6.When an enterprise applies for multiple products, it first confirms whether the products meet the technical requirements formulated by itself. If it wants the testing institute or the evaluation center to tell him whether it is OK or not, what additional items need to be done is unreasonable in itself. After self -inspection, the enterprise should draw the items requiring difference detection and submit the Research Report;

7.In addition, the model and specification applied by the enterprise should be the finished products that have been produced. We have found many cases in the review process, that is, the enterprise applies without making products at all. In this case, it is reasonable to apply for the change of licensing matters after making products next time.

BradyKnows has seasoned staff in registration and can help manufacturers on legal compliance. If you have any questions, please feel free to contact us  info@bradyknowsmedical.com for more information.