BRACE provides turnkey support for the amendment process, from the initial risk assessment to obtaining the updated document from Roszdravnadzor (the "Federal Service for Surveillance in Healthcare").

Why Update Registration Documents?

Any changes to product characteristics or manufacturer data require a legal assessment. Even minor adjustments may lead to a product being deemed "unregistered" if the dossier does not reflect them.

Risks of Untimely Amendment

Discrepancies between actual product characteristics and MA information create significant legal risks for businesses:

• Administrative Liability: under Art. 6.28 and Art. 6.33 of the CAO RF.
• Suspension of Business Operations: withdrawal of products from circulation and suspension of supplies.
• Criminal Liability: in certain cases under Art. 238.1 of the Criminal Code of the Russian Federation.

Regulatory Framework

The procedure is strictly regulated. Effective March 1, 2025, the new Rules of State Registration of Medical Devices, approved by the Resolution of the Government of the Russian Federation No. 1684 dated November 30, 2024, enter into force.

The new rules introduce a refined algorithm for assessing changes and determine when dossier adjustments require additional quality, efficiency, and safety expertise.

Which Changes Must Be Reflected in the MA?

For clarity, we have grouped the most common amendment cases in the table below:

Category of Changes	Specific Adjustments
Identification Data	Name or address of the manufacturer or the Marketing Authorization Holder (the "MAH").
Product Parameters	Medical device name, addition/removal of models or sizes.
Technical Data	Changes to design, software, components, or materials.
Operational	Updating instructions for use, changing labeling or packaging.
Manufacturing	Changing or adding new manufacturing sites.

Amendment Scenarios: With and Without Expertise

The key issue in amending a medical device marketing authorization is whether the changes affect the product's safety and effectiveness. This determines the complexity and timeline of the process.

Parameter	Without Expertise	With Expertise
Basis	Changes do not affect functional characteristics or principles of operation.	Changes may affect quality, safety, or effectiveness.
Examples	Address change, packaging design change, typo correction.	Replacement of primary material, expansion of indications for use, software changes.
Complexity	Simplified procedure, verification of document completeness.	In-depth analysis of technical and clinical documentation by experts.
Risk	Minimal with correct documentation.	Requires substantiating that the changes have no negative impact on quality, safety, or effectiveness.

Important: If the regulator deems changes significant (changing the product's essence), a new registration procedure may be required. BRACE experts conduct a preliminary audit to prevent such a scenario.

Procedure and Required Documents

The Roszdravnadzor process involves submitting an application through the electronic portal, followed by formal verification and, if necessary, an expertise stage. The applicant may receive a request that requires a response within 30 business days.

Standard Set of Documents:

1. Standard application form.
2. Manufacturer’s power of attorney.
3. Documents and data confirming the declared changes (including technical documentation, reports, certificates, and other supporting materials).
4. Substantiation that the declared changes do not affect product quality, effectiveness, or safety (for amendments without expertise).
5. Original or duplicate of the current MA.

The required documentation may be expanded depending on the risk class of the medical device and the nature of the changes.

Advantages of Working with BRACE

We ensure regulatory process predictability at every stage:

• Regulatory Audit: we assess the likelihood of an expertise appointment before submitting documents.
• Preparation of the Registration Dossier: updating and aligning technical documentation with current regulatory requirements.
• Interaction with Roszdravnadzor: preparing responses to inquiries and legal/expert review of the regulator’s comments.
• Legal Protection: we minimize the risk of rejections and unreasonable delays.

Order Amendment of Marketing Authorizations

BRACE specialists will help you update your regulatory documentation in accordance with the new requirements.