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.
01
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
without changing the properties and characteristics
for a medical device (for medical devices manufactured in Belarus)
- 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
to medical devices or changing their titles
that do not affect the principle of operation and functional purpose (changes in the parameters of length, diameter, volume, size).
02
ЭТАПЫ ПРОЦЕДУРЫ:
01
Collection and analysis of documents
02
Correction of the registration dossier documents
03
Preparation of an import permit (if necessary)
04
Import of samples (if necessary)
05
Collection and submission of the registration dossier
06
Making corrections (if necessary)
07
Receiving the registration certificate
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