Equipment Review Added:Registration Unit Division, Analysis of Performance Evaluation Related Questions and Answers!

Q. How to divide the product registration units of facial injection filling materials?

A. According to the guideline of the division of medical device registration unit (three), “product structure composition or processing method leads to different product performance indicators, which are divided into different registration units in principle”. When filling the face injection material, the chemical composition, the ratio (concentration), the crosslinking method, the crosslinking degree, the gel particle size distribution, the design average molecular weight and their distribution are different. In principle, they should be divided into different registration units.

For the same declared product, those used in different parts of the face, such as changing the contour of the middle of the face and augmentation of the nose, can be divided into the same registration unit.

Q. In the evaluation of analytical performance of in vitro diagnostic reagents, samples from different sources are required to be used for research. How to understand “different sources”?

A.   In order to investigate the analytical performance of in vitro diagnostic reagents, it is usually required to select suitable population samples with different time, different places and different representativeness (such as age, gender, race, other conditions, etc.) for the evaluation of detection ability, that is, select samples from “different sources” for evaluation. The selection of representative samples shall be determined according to the characteristics of the product itself and the expected clinical use.

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