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Registration process
REGISTRATION OF MEDICAL DEVICES ACCORDING TO THE RULES OF THE EAEU

Stage 1:

Conducting a preliminary analysis.

The analysis includes:

- determining the risk class of the product;

- selecting a registered analogue of a medical device: type, class, number of registration certificates (whether it will be sufficient to have one for all components of the product or several individual certificates will be required);

- compiling a list of competitors - analogues of your medical device in the market with their registration certificates indicated;

- calculating the registration time;

- calculating the cost of services by stage with a breakdown by time (including the selection of the necessary studies).

2. Filing an application for registration.

3. Collecting and preparing of all documents.

4. Preparing the registration dossier. This also includes:

— technical tests;

— studies intended to assess the biological effect;

— trials to approve the type of measuring instruments for medical devices classified as measuring tools;

— conducting clinical trials (or including already existing clinical data in the registration dossier).

5. Selecting the reference state and recognizing states. You can choose institutions and organizations of any EAEU member state as an applicant: Republic of Armenia, Republic of Belarus, Republic of Kazakhstan, Kyrgyz Republic.

6. Payment of the duty.

 

Stage 2:

1. Submitting documents to the reference state (Roszdravnadzor).

2. The reference state's organization posts the electronic registration dossier on the EAEU's information website. The following activities take place:

— inspection of the production process for medical devices of Risk Class 2b and 3 risk class, sterile medical devices of Risk Class 2a;

— preparation of an expert opinion.

3. Submitting the dossier to experts of the recognizing state for approval.

Not approved: Regfort makes adjustment subject to the experts' comments and resubmits the revised dossier.

4. Coordinating the expert opinion with experts from other countries with regard to the opinion.

Not approved:
Resolving disagreements with the Eurasian Economic Commission.
The expert organization of the recognizing state provides comments or issues a rejection notice. Regfort assumes the responsibility for communicating and making amendments to documents prior to approval.

5. Registering and including the medical device in a unified register. This opens access to the common EAEU market.

 

 

MAKING CHANGES

Process of making changes to registration documentation on a medical product.

STAGES:

1. Collection and preparation of all documents

2. Application for VIRD

3. Preparation of technical documentation on Federal Service for Surveillance in Healthcare requirements

4. Technical and toxicological tests

5. Carrying out clinical tests

6. Generation and submission of a set of registration files

7. Review of completeness of documents, efficiency and safety analysis

8. Obtaining registration certificate

Process of making changes to the registration certificate for the medical product.

STAGES:

1. Collection and preparation of all documents

2. Processing of the application for VIRU and preparation of the necessary documentation on the requirements of Federal Service for Surveillance in Healthcare

3. Generation and submission of a set of registration files

4. Obtaining registration certificate

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