Making changes to the registration certificate / dossier
Medical devices which are used on the territory of the Republic of Belarus must comply with the Registration Certificate. Making changes to the Registration Certificate/dossier is the only way to update information about a medical device.
When do i need to make changes to the registration certificate / dossier?
The Manufacturer or an Authorized Representative is obliged to initiate the procedure for making changes no later than 90 calendar days in the case of:
- changes in the title of the medical device
- introduction of a new medical indication
- reorganization and (or) change of the manufacturer's title
- changes to the production site
- amendments to the manufacturer's technical regulations
- adding (excluding) accessories
- Cosmetics having therapeutic and prophylactic properties
- changes in labeling and/or packaging
- changes in expiration dates and (or) storage conditions
- changes in the class of potential risk
- changes in the instructions for use
- changes in the size range of medical devices