The EEC Board approved the criteria for inclusion in one certificate of registration of several modifications of medical devices belonging to the same species... The EEC Board approved inclusion criteria several modifications of the medical device in one regulatoarele

The EEC Board approved the criteria for inclusion in one certificate of registration of several modifications of medical devices belonging to the same species of a medical device in accordance with the applied in the Eurasian economic Union nomenclature of medical devices.

The EEC Board decision №123 from 24.07.2018 G. shows when possible the simultaneous recording of a line of such products under one registration certificate. In particular, this may be the case, if production modifications of the medical device by a single manufacturer and a single technical documentation; modification of the medical device belong to the same class of potential risk; modification of the medical device have a different configuration, not affecting the principle of operation and functionality, which allows for extension or specialization of their use for medical purposes, etc.

The solution will allow manufacturers of medical devices manage the registration work and reduce their costs.

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