Making changes to the registration certificate
We streamline the amendment submission, ensuring that any changes to technical and operational documents adhere to state standards, and if necessary, undergo the appropriate review for quality, efficacy, and safety without altering the medical device’s intended use or mechanism.
The procedure for amending the registration certificate
Updating Medical Device Registration Certificates
This procedure is carried out in accordance with paragraphs 37 and 38 of the Government Resolution of the Russian Federation No. 1416 dated 27.12.2012 “On Approval of the Rules for State Registration of Medical Devices.”
Amendments to the registration certificate according to subparagraph “a” of paragraph 37 of the Rules:
(It’s important to note that within the procedure for amending the registration certificate, the applicant is the manufacturer of the medical device):
a) Change of information about the applicant (manufacturer):
- About the reorganization of the legal entity;
- Change of legal entity (another manufacturer);
- About changes in its name (full and (if available) abbreviated, including the trade name),
- Change of address (location) of the applicant (manufacturer).
Documents Confirming the Reorganization of a Legal Entity and/or Change of Address of the Legal Entity’s Location:
- Extract from the Unified State Register of Legal Entities (EGRUL), confirming the reorganization of the legal entity (change of address), founding documents of the entity (changes in the charter)
- Documents confirming the reorganization of a legal entity (relevant agreements, letters, orders)
- Certificate of Origin from the Chamber of Commerce, or other documents verifying changes in the country of origin (for foreign-made products).
The documents should contain information that allows for the identification of the date when the changes to the founding documents occurred.
Documents Confirming the Change of the Applicant’s (Manufacturer’s) Name:
A letter from the manufacturer outlining the nature of the implemented amendments, specifically:
- The amended charter
- An extract from the Unified State Register of Legal Entities
- The foundational legislative act regarding the company’s renaming
- Resolutions from the company’s founding members
- Internal documents of the legal entity (pertinent agreements, correspondence, orders).
Documents Confirming the Change of Legal Entity (Another Manufacturer):
- Manufacturer’s documents that confirm the allocation of quality responsibility for previously manufactured products (such as a letter).
- Documentation verifying the transition of rights to the registered manufacturing location, including production, development, and documentation from the “previous owner” to the “new owner.”
- Outcomes of required qualification testing in accordance with GOST P 15.013-94 (for the manufacturer), if the “new” manufacturer qualifies as a “distinct manufacturing site.”
- ISO 13485 and 9001 certifications, declarations of conformity (for internationally manufactured devices), and licenses.
Changing the Address of the Medical Device Manufacturing Location According to Subparagraph “b” of Paragraph 37 of the Rules for State Registration of Medical Devices
Documents that verify the manufacturer’s name and facility location for the medical device, inclusive of a letter from the manufacturer acknowledging the registration of (authorized) premises, such as:
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- ISO 13485, 9001, CE certifications;
- A license for the manufacturing and technical servicing of medical equipment (if it’s a licensed activity);
- A declaration of conformity for the medical device;
- Additional documents as required by the legislation of the country of origin.
The aforementioned documents should contain information regarding the manufacturer’s responsibility.
Changing the Name of the Medical Device According to Subparagraph “c” of Paragraph 37 of the Rules for State Registration of Medical Devices:
- Declaration specifying the updated name of the medical device
- Details on regulatory documentation
- Manufacturer’s technical documentation for the medical device, updated to reflect the new device name and in compliance with Federal Regulations
- Manufacturer’s supplementary documentation for the medical device, including usage instructions or a manual, updated to match the new device name and in accordance with Federal Regulations
- Photographic representation of the medical device’s overall appearance with any necessary accessories for use as intended (minimum size of 18×24 centimeters)
- Documentation validating the registration and utilization of the trademark mentioned in the manufacturer’s declaration (if a trademark is indicated)
To confirm the consistency of the properties and characteristics affecting quality, efficacy, and safety of the medical device, and the enhancement of its functional purpose and/or operating principle, Roszdravnadzor may request protocols of relevant tests to verify the authenticity of the data provided by the applicant.
Changing Information About the Legal Entity to Whom the Registration Certificate Can Be Issued, According to Subparagraph “g” of Paragraph 37 of the Rules:
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- Contains information on: the reorganization of a corporation; modification of the corporate entity;
- regarding the alteration of its name (complete and (if applicable) shortened, including the business name),
- modification of address (location)
- Documentation confirming fundamental changes due to this cause, analogous documents, submitted during the update of applicant information.
The aforementioned documents should contain information regarding the manufacturer’s responsibility.
18Specifying the Type of Medical Device According to Subparagraph “d” of Paragraph 37 of the Rules:
- A statement specifying the type of medical device
- Information on the regulatory documentation
- Manufacturer’s technical documentation for the medical device, compliant with Section 4 of the Regulations – including operational documentation from the manufacturer such as the user manual or operating instructions for the medical device, in accordance with Section 4 of the Regulations
- A photographic image showing the overall view of the medical device along with any accessories required for its intended use (size not smaller than 18×24 centimeters)
Paragraph 38 of the Government Resolution of the Russian Federation No. 1416 dated 27.12.2012 “On Approval of the Rules for State Registration of Medical Devices.”
To amend the registration certificate, the applicant must, no later than 30 business days following the date of alterations, furnish or dispatch to the registering body a notification of the revisions applied to the registration certificate, formatted per Section 9 of the Regulations, accompanied by the enumerated changes and verification that the adjustments in the registration certificate do not modify the attributes and characteristics impacting the quality, efficacy, and safety of the medical device, or the constancy of the functional intent and (or) operational principle of the medical device, along with the ensuing documents:
- a copy of the document endorsing the delegation of the authorized manufacturer’s (producer’s) representative;
- number of the registration certificate;
- outline of documents
We manage your project at every stage of its review, providing professional assistance in dossier preparation, addressing remarks, and crafting well-reasoned responses to inquiries from expert services.
Please send us your request; our registration specialists will analyze your existing data, determine the optimal registration process, assess the scope of work needed for dossier preparation, and provide you with a commercial offer for these services.
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