Development of Medical Device Technical Documentation (TS) in Russia & EAEU

BRACE Law Firm specializes in the turnkey preparation of technical documentation for two categories of clients:

For Russian manufacturers: development of full Technical Specifications (the "TS").
For foreign manufacturers: preparation of Technical Documentation (the "TS Analog") in Russian for integration into the registration dossier.

Comparison of Requirements: RF vs. Foreign Manufacturers

While the objectives of the documents are similar, their legal nature and structure differ depending on the product's origin and the chosen registration path (national or EAEU).

Parameter	Technical Specifications (for RF)	Technical Document (for imports)
Basis	GOST 2.114-2016 or specialized standards, considering the requirements of Order No. 11n of the Ministry of Health of Russia or Decision No. 46 of the Council of the EEC.	Order No. 11n of the Ministry of Health of Russia or Decision No. 46 of the Council of the EEC.
Essence	The primary design document of the plant.	An adapted translation of the Technical File for RF/EAEU standards.
Language	Russian.	Russian (based on the original).

Why Simple Translation of the Technical File Is Insufficient

A simple translation of the Technical File is insufficient for foreign medical devices. A document in Russian is required to serve as the TS during testing and expertise. BRACE conducts an analysis to eliminate typical discrepancies:

Terminology: Aligning names of models and components across all dossier documents.
Standards: Mapping international standards (ISO, IEC) to the GOSTs effective in the Russian Federation.
Risk Management: Adapting the risk management file to national requirements.

Checklist: What Is Required from a Foreign Manufacturer?

To enable us to prepare a high-quality technical document, the manufacturer must provide:

Technical File (current version).
Instructions for Use.
Quality Certificates (ISO 13485, CE, declarations of conformity).
Factory Test Protocols (technical, biological, clinical).
Labeling Layouts (packaging, label).

Stages of Development at BRACE

Initial Audit: Assessment of the completeness of the provided information.
Document Drafting: Writing the TS or the Technical Document according to national norms or EAEU rules.
Operational Section: Developing instructions for use and operation manuals.
Validation: Internal verification of documentation before submission to Roszdravnadzor to prevent returns.

Why Errors in Documentation Are Dangerous

An incorrectly prepared document is the main cause of registration delays:

Refusal to accept the dossier: If the document structure does not comply with Order No. 11n or Decision No. 46.
Contradictions in protocols: If the TS declares certain characteristics, but different ones were verified during testing.
Customs issues: Discrepancy between the description in the documents and the actual composition of the product when importing samples.

Order Technical Documentation Development

BRACE experts ensure the legal and regulatory accuracy of your documents. We assist in both localizing foreign products and launching the production of new domestic products.

Contact us to discuss your project and receive a commercial proposal.