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MEDEXPERT

Updates of the registration documentation

Making changes to the registration documentation (dossier) of a medical device when it is circulated on the market of the Russian Federation, in accordance with Federal Law No. 323-FZ dated November 21, 2011 "On the Basics of Protecting the Health of Citizens in the Russian Federation"

The changes made to the documents contained in the registration dossier that do not require an examination of the quality, effectiveness and safety of a medical device include:

a) change of information about the applicant, including information:
  • on the reorganization of a legal entity;
  • on changing the name of the legal entity (full and (if available) abbreviated, including the company name), the address of its location;
  • on changing the surname, first name and (if available) patronymic, address of the place of residence of the individual entrepreneur and the details of the identity document;

b) changing information about the person in whose name a registration certificate for a medical device may be issued, including information:
  • on the reorganization of a legal entity;
  • on changing the name of the legal entity (full and (if available) abbreviated, including the company name), address of its location or surname, first name and (if available) patronymic, place of residence of the individual entrepreneur;

c) changing the address of the place of production (manufacture) of a medical device;

d) a change in the name of a medical device if the properties and characteristics NOT affecting the quality, effectiveness and safety of a medical device, or its properties and characteristics are being improved with the functional purpose and (or) the principle of operation unchanged, providing:
  • adding (excluding) accessories of a medical device or changing their name;
  • indication, modification and exclusion of a trademark and other means of individualization of a medical device;
  • change in the number of units of a medical device or its components, components specified in the appendix to the registration certificate;
  • indication or exclusion of variants (models) of a medical device;
  • changing the labeling and (or) packaging of a medical device;

e) modification by the manufacturer of the medical device of the validity period of the documents contained in the registration dossier;

f) changing the information about the authorized representative of the manufacturer of the medical device.

Changes to the technical and operational documentation of the manufacturer for a medical device (which have entailed changes in properties and characteristics affecting the quality, effectiveness and safety of a medical device, or improves its properties and characteristics while maintaining the functional purpose and (or) the principle of operation of a medical device) are carried out based on the results of an examination of the quality, effectiveness and safety of a medical device products. With the exception of the cases specified in subparagraph "d" of paragraph 37 of PP RF 1416 dated 12/27/2012, indicated above.

For conducting an examination of the quality, effectiveness and safety of a medical device when making changes to the documents contained in the registration dossier of a medical device:

Class 1

32 000 ₽

Class 2a

48 000 ₽

Class 2b

64 000 ₽

Class 3

104 000 ₽

* 1₽  = 0.01$ 

Algorithm of making changes:

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Analyzing your task and documentation preparation

First of all, we need to determine the reasons for making changes, as the volume of materials provided depends on it, as well as the need for testing and expertise. In each case, a unique set of documents to be prepared reflecting the type changes being made.

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Submission of documentation and decision of Roszdravnadzor
The documents are submitted to the FS Roszdravnadzor within 30 working days from the date of the changes.
Experts review the documentation:
— 5 working days if there is no need to conduct an examination of the quality, effectiveness and safety of a medical device;
— 35 working days, if necessary, to conduct an examination of the quality, effectiveness and safety of a medical device.

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Applying the changes

Roszdravnadzor makes changes to the registration documentation within 15 business days.

Making changes to the registration documentation (dossier) of a medical device when it is circulated within the framework of the Eurasian Economic Union, in accordance with the legislation of the Eurasian Economic Union.

Changes to the registration dossier requiring registration of a new medical device include:

a) changes entailing a change in the functional purpose and (or) the principle of operation of a medical device;

b) inclusion of information about models (brands) of a registered medical device that do not meet the criteria for inclusion in one registration certificate of several models (brands) of a medical device;

c) changes entailing simultaneous changes in information about the manufacturer and the production site (production sites) in relation to the information specified in the registration certificate issued as part of the registration and examination procedures for a medical device, with the exception of information about the organizational and legal form, address, reorganization, and other information contained in the statutory documents.

The procedure for making changes to the registration dossier as the notification procedure is applied in the following cases:

a) the changes relate to the validity period of the documents contained in the registration dossier (updating of the documents of the registration dossier by the applicant);

b) changes are made by the manufacturer of medical devices  of the class of potential risk of use 1 or non-sterile medical devices of the class of potential risk of use 2a, who has passed the assessment of the quality management system of the medical device (including the processes of design and development of medical devices) in accordance with the Requirements of the quality management system;

c) the changes relate to the following information about the manufacturer of the medical device or its authorized representative:
  • the name of the legal entity (full and abbreviated (if available), including corporate names), the address of the location or the address of the place of business;
  • surname, first name, patronymic (if any), address of the place of residence of the individual entrepreneur or the address of the place of business and details of the identity document;

d) changes in the name of a medical device in terms of a trademark and other means of individualization;

e) the changes consist in the exclusion of information about the model (brand) of a medical device from the registration certificate.

The procedure for making changes to the registration dossier (with the exception of changes for which a notification procedure is provided) requires a procedure for approving an expert opinion with the States of recognition indicated in the registration certificate.

For conducting an examination of the safety, quality and effectiveness of a medical device when making changes to the documents contained in the registration dossier of a medical device, as well as for approving an expert opinion on the assessment of the safety, effectiveness and quality of a medical device when making changes to the documents contained in the registration dossier of a medical device:

Class 1

32 000 ₽

Class 2a

48 000 ₽

Class 2b

64 000 ₽

Class 3

104 000 ₽

* 1₽  = 0.01$ 

Algorithm of making changes:

●○○

Analyzing your task and documentation preparation

First of all, we need to determine the reasons for making changes, as the volume of materials provided depends on it, as well as the need for testing and expertise. In each case, a unique set of documents to be prepared reflecting the type changes being made.

●●○

Submission of documentation and review

The documents are submitted to the Roszdravnadzor within 90 working days from the date of the changes.

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Making changes to the registration documentation with placement in the Unified Register of Medical Devices registered within the Union, information on making changes to the registration dossier in accordance with the Procedure for forming and maintaining an information system, as well as scanned copies of documents that have been amended.

The algorithm for making changes that require the procedure for approving an expert opinion with the States of recognition specified in the registration certificate:

●○○○

Analyzing your task and documentation preparation

First of all, we need to determine the reasons for making changes, as the volume of materials provided depends on it, as well as the need for testing and expertise. In each case, a unique set of documents to be prepared reflecting the type changes being made.

●●○○

Submission of documentation and review

The documents are submitted to the Roszdravnadzor within 90 working days from the date of the changes.

●●●○

Passing the procedure for approving an expert opinion in the countries of recognition.

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Making changes to the registration documentation with placement in the Unified Register of Medical Devices registered within the Union, information on making changes to the registration dossier in accordance with the Procedure for forming and maintaining an information system, as well as scanned copies of documents that have been amended.