Registration of medical product – step-by-step.
STAGES:

1. Collection and preparation of all documents

2. Application for registration

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 registration of a domestic medical product
1 risk class or in vitro diagnostics.

Registration process

STAGES:

1. Collection and preparation of all documents

2. Application for registration

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

4. Technical and toxicological tests

5. Generation and submission of a set of registration files

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

7. Obtaining permission for clinical trials

8. Carrying out clinical tests

9. Resubmission of file set

10. Check of completeness of documents

11. Obtaining registration certificate
Process of registration of the domestic medical product 2a, 2b, 3 risk class.
DOMESTICMEDICAL PRODUCT
FOREIGN MEDICAL PRODUCT
STAGES:

1. Collection and preparation of all documents

2. Application for registration

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

4. Import of samples of medical products

5. Technical and toxicological tests

6. Carrying out clinical tests

7. Generation and submission of a set of registration files

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

9. Obtaining registration certificate.
Registration of foreign medical product 1 risk class or in vitro diagnostics.
STAGES:

1. Collection and preparation of all documents

2. Application for registration

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

4. Import of samples of medical products

5. Technical and toxicological tests

6. Carrying out clinical tests

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

8. Obtaining permission for clinical trials

9. Carrying out clinical tests

10. Resubmission of file set

11. Check of completeness of documents

12. Obtaining registration certificate
Registration process of foreign medical product
2a, 2b, 3 of risk class.
MAKING CHANGES
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 registration documentation on a 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
Process of making changes to the registration certificate for the medical product.
Get a free step-by-step registration scheme for your medical product
MAKING CHANGES
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 registration documentation on a 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
Process of making changes to the registration certificate for the medical product.
Get a free step-by-step registration scheme for your medical product