Making changes to the registration dossier Russia
Changes to the registration dossier are made if the registration authority, based on the results of checking the completeness and reliability of the information contained in the submitted documents, establishes that the introduction of the declared changes entails a change in the properties and characteristics that affect the quality, effectiveness and safety of the medical device or improves its properties and characteristics while maintaining the same functional purpose and (or) principle of operation of the medical device.
Changes to the registration dossier are made:
In accordance with paragraph 39 of Resolution of the Government of the Russian Federation No. 1416 dated 27 December 2012 “On Approval of the Rules for the State Registration of Medical Devices” (as amended and supplemented) if it is necessary to make changes to the registration dossier, this is carried out in the following cases:
- Changing the design or completeness of the product;
- Application of new materials
- Adding new design versions of the medical device
- Changing the labelling of the medical device, etc
