Introduction of amendments to the regulated documents. Duplicate of the registration certificate

Introduction of amendments to the regulated documents

The registration dossier may be amended. Depending on the reason for making amendments, the dossier can be checked during an expert examination, or it can be reviewed by Roszdravnadzor without an expert examination.
If the reason implies the examination, then another state fee must be paid.
The amount of the state fee depends on the risk class of the medical device:

  • 20,000 rubles (class 1)
  • 30,000 rubles (class 2a)
  • 40,000 rubles (class 2b)
  • 55,000 rubles (class 3)

The following changes can be made to the dossier without examination:

1. Change the details of an applicant:
— on the reorganization of a legal entity;
— on the change in the name of the legal entity,
— on the address of its location;
— on the change of the first name, patronymic, and last name, address of the place of residence of an individual entrepreneur and the details of his identity document.

2. Change information about the person in whose name a registration certificate for a medical device can be issued:
— on the reorganization of a legal entity;
— on changing the name of the company;
— on changing the address of the organization’s location;
— on changing the first name, patronymic, and last name, place of residence of an individual entrepreneur.

3. Change the address of the place of production (manufacture) of a medical device.

4. Change the name of the medical device.

5. Add or remove medical device accessories.

6. Change the name of the medical device accessories.

7. Specify, change, exclude a trademark.

8. Change the number of units of a medical device or its constitutive parts, components.

9. Specify or exclude designs (models) of a medical device.

10. Change the labeling and/or packaging of the medical device.

11. Change the validity period of the regulated documents.

12. Change the information about the authorized representative of the producer (manufacturer) of the medical device.
The main conditions for making changes to the dossier without conducting an examination are the following:
— the invariability of properties and characteristics that affect the quality, efficiency and safety of the medical device,
— the invariability of the functional purpose and (or) the operating principle of the medical device.

In other circumstances, when the technical and operational documentation changes, the documents will be checked, in other words, the quality, efficiency and safety of the medical device will be examined.

To make changes to the registration documents, the applicant, within 30 working days from the date of the change, submits to Roszdravnadzor:
— an application on amendments being made to the registration documentation for a medical device,
— a payment order for payment of the state fee,
— documents confirming the changes being made.

The state feed for making changes is 1500 rubles.

If the application for amending contains inaccurate information or the documents are not submitted in full, then Roszdravnadzor gives 30 days to eliminate the violations.

Roszdravnadzor, on the basis of the documents submitted by the applicant, makes a decision on the possibility/impossibility of making changes to the registration documentation for a medical device.

You can contact us rustam@medexpert.ru for help in making changes to the regulated documents.

Duplicate of the registration certificate

If you have lost or damaged the original registration certificate, you can issue a duplicate.
If the original copy is damaged, then the damaged registration certificate is attached to the application.
To issue a duplicate, it is necessary to pay a state fee of 1500 rubles.

he applicant must have an instrument of delegation from the manufacturer.
For advice on making a duplicate, please contact rustam@medexpert.ru