Making changes to the registration certificate / dossier in Belarus
Medical devices that 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.
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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?
- 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
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:
without changing the properties and characteristics
for a medical device (for medical devices manufactured in Belarus)
- adding (excluding) accessories
- 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
adding (excluding) accessories
that do not affect the principle of operation and functional purpose (changes in the parameters of length, diameter, volume, size).
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Stages of making changes to the registration certificate / dossier
1 STAGE
Preparation of the registration dossier
collection of a package of documents of the registration dossier
2 STAGE
Preliminary analysis of the registration dossier
evaluation of the dossier with adjustments (if necessary)
3 STAGE
Submission of an application for the procedure
to the state body for the conclusion of a contract for the primary examination of documents
4 STAGE
Primary examination of documents
with the issuance of a conclusion based on the results of the primary examination
5 STAGE
Sanitary and hygienic examination (if necessary)
with the provision of specimens and receipt of test certificates (in case of changes affecting the quality and safety of medical products)
6 STAGE
Inspection of production (if necessary)
when changing the production site
7 STAGE
Clinical trials (if necessary)
in clinics with changes affecting the quality, safety and effectiveness of medical products (mainly for medical products manufactured in Belarus)
8 STAGE
Specialized examination of the dossier (if necessary)
specialized by the specialists of the Ministry of Health of the Republic of Belarus with the issuance of a conclusion on the compliance of medical products with quality, safety and efficiency requirements
9 STAGE
Session of the Commission on Medical devices of the Ministry of Health of the Republic of Belarus
with the adoption of a decision to amend the registration dossier / certificate for medical products and the issuance of a Notification letter
10 STAGE
Issuance of a registration certificate
(when making changes to the registration certificate) with the placement of information in the state register of medical products of the Ministry of Health of the Republic of Belarus
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