Medical Device Technical Testing in Russia from September 1, 2026

From September 1, 2026, foreign manufacturers registering medical devices in Russia need to follow updated technical testing rules covering application review, testing timelines, grounds for refusal, the new technical testing protocol, and separate requirements for certain IVD products.

Foreign manufacturers preparing to register a medical device in Russia after September 1, 2026 need to take into account a revised technical testing procedure. The changes affect several practical parts of the process, including application review, testing timelines, reasons why a testing organization may be unable to conduct the required testing, and the document issued at the end of testing.

The new rules are established by Russian Ministry of Health Order No. 421n of May 13, 2026, which replaced Order No. 885n. They apply to technical testing performed as part of the state registration of medical devices in Russia and, where required, amendments to an existing registration dossier.

Technical testing is used to confirm that the device's declared technical and functional characteristics are consistent with its technical and operating documentation.

The purpose of technical testing itself has not changed. What has changed is how the process is handled and documented. Technical testing results are now issued in a different format, the rules for extending testing timelines are more specific, and certain categories of in vitro diagnostic medical devices (IVDs) no longer require technical testing.

For registration projects already in progress around the September 1 transition date, the key factor is when the technical testing application was submitted. Applications filed before September 1, 2026 continue under the previous procedure, even if the testing is completed later.

TL;DR: Key Changes to Medical Device Technical Testing from September 1, 2026

New rules apply from September 1, 2026. Technical testing is conducted under Russian Ministry of Health Order No. 421n.

A protocol replaces the previous assessment act. Technical testing results are now documented in a technical testing protocol.

Applications are reviewed within 10 business days. Once a decision is made, the applicant must be notified within three business days.

The reasons why testing may not proceed are defined more clearly. These include issues with the testing organization's accreditation scope or technical capability, as well as non-compliant applications or supporting documents.

Technical testing normally takes up to 30 business days. An extension of up to 20 business days is possible when the applicable testing method or methodology requires additional time.

Certain IVD products no longer require technical testing. This applies to specified reagents, calibrators, control materials, and other categories covered by the new procedure.

What Changed in Medical Device Technical Testing in Russia from September 1, 2026?

From September 1, 2026, technical testing results are issued as a protocol instead of an assessment act, the rules for extending testing timelines have changed, and the grounds on which testing may not proceed are defined in greater detail. Certain IVD reagents and materials are also no longer subject to technical testing, while the standard testing period remains up to 30 business days.

Key Changes to Medical Device Technical Testing in Russia from September 1, 2026

Area	Before September 1, 2026	From September 1, 2026
Technical testing results	Results were documented in an assessment act.	Results are documented in a technical testing protocol.
Extension of testing timelines	The testing period could be extended by agreement with the applicant for up to 20 business days.	An extension of up to 20 business days is allowed only when a longer period is required by the applicable testing method or methodology. The applicant must be notified within three business days of the decision.
Technical testing for certain IVD products	Some reagents and supporting materials underwent reduced-scope testing for identification and verification of basic parameters.	Technical testing is no longer required for specified reagents, reagent kits, control materials, calibrators, washing solutions, diluents, plastic consumables used with IVD reagents, and culture media.
Cases where testing cannot proceed	Testing could be declined where the necessary conditions were unavailable or the submitted materials did not meet the requirements.	The rules now specify grounds such as an insufficient accreditation scope, equipment problems, scheduled work affecting necessary equipment, and non-compliant applications or document packages. The applicant must be notified within three business days and given the reasons.

For a foreign manufacturer, the practical takeaway is that a testing approach prepared under the previous procedure should not automatically be reused for a new project. Before filing an application, the manufacturer should confirm which procedure applies, whether the selected testing organization can perform the required work, and whether the documentation meets the current requirements.

For a broader overview of the medical device conformity assessment changes that took effect in Russia on September 1, 2026, including changes beyond technical testing, see our article "New Medical Device Conformity Assessment Rules in Russia from September 1, 2026."

How Does Medical Device Technical Testing Work in Russia in 2026?

Medical device technical testing in Russia involves more than testing the device itself. The process begins with application review and preparation of the testing program, followed by submission of the device and supporting materials, the testing itself, and issuance of the final protocol. The purpose of the process is to confirm that the medical device's technical and functional characteristics correspond to the manufacturer's documentation and declared parameters. An accredited testing organization performs the work under an approved testing program. The results are then recorded in a technical testing protocol.

The process generally includes six stages:

1. Application and document submission. The applicant provides the technical testing application together with the required technical and operating documentation.

2. Initial review. The testing organization determines whether it has the required accreditation scope, equipment, methods, and technical capability to perform the work.

3. Testing program preparation. The program defines what will be tested, which characteristics will be evaluated, which methods will be used, and under what conditions the testing will take place.

4. Submission of the medical device and supporting materials. The applicant provides the medical device sample and accessories. Depending on the device, special equipment, software, or test databases may also be required

5. Technical testing. The device's technical and functional characteristics are checked against the declared parameters and manufacturer documentation.

6. Final documentation. Once testing is complete, the results are documented in a technical testing protocol for use in the medical device registration process.

What Is Checked During Medical Device Technical Testing in Russia?

Technical testing is designed to confirm that the medical device performs as described by the manufacturer and that its actual characteristics are consistent with the documentation submitted for registration. There is no single standard checklist for every medical device. The testing program is determined individually based on the device's intended purpose, design, technical characteristics, and the parameters that need to be confirmed.

Depending on the medical device, the testing program may cover:

• functional characteristics;
• declared technical parameters;
• compliance with regulatory and technical documentation;
• consistency between the operating documentation and the device's actual characteristics;
• safety and performance under the intended conditions of use;
• completeness, accessories, and compatibility of individual components;
• software characteristics where software forms part of the medical device or is itself a medical device;
• correctness of the assigned potential risk class.

For a foreign manufacturer, this makes consistency between the physical device and its documentation especially important: the testing program is built around the characteristics and intended use declared for the specific product.

Who Can Perform Medical Device Technical Testing in Russia?

Medical device technical testing must be performed by a testing organization whose accreditation scope covers the required work. However, accreditation alone does not guarantee that a particular organization can accept a specific device for testing. The organization must also have the equipment, personnel, testing methods, and technical capability needed to complete the required testing program.

This means that laboratory selection should be based on the specific device and planned scope of testing, not simply on whether the organization holds accreditation.

The testing organization must also remain impartial and must not be dependent on the applicant, manufacturer, or other parties interested in the outcome of the conformity assessment.

Before submitting an application, it is therefore useful to confirm:

• that the required work falls within the organization's accreditation scope;
• that the required equipment is available;
• that the organization can apply the necessary testing methods and methodologies;
• that it has the technical capability to complete the full testing program for the specific medical device.

What Documents Are Required for Medical Device Technical Testing in Russia?

For a foreign manufacturer, the document package needs to do several things at once: identify the device and manufacturer, explain the product and its intended use, describe its technical characteristics, and confirm who is authorized to act on the manufacturer's behalf. The exact package depends on the medical device.

Core Document Package for Medical Device Technical Testing in Russia:

1. Application, Manufacturer and Authorization Documents

• the technical testing application containing the required information about the medical device, manufacturer, and applicant;
• documents confirming the authority of the manufacturer's authorized representative, where applicable;
• proof of authority where another person submits the application on behalf of the applicant.
• documentation confirming the registration of the foreign manufacturer as a legal entity or individual entrepreneur.

2. Technical and product documentation

• information on the regulatory documentation applicable to the medical device;
• the manufacturer's technical documentation;
• operating documentation, including the instructions for use or operating manual.

3. Additional product-specific documents, where applicable

• trademark and other identification documentation where such elements appear on the packaging;
• documents confirming the quality of medicinal products, pharmaceutical substances, biological materials, or other substances included in the medical device;
• supporting evidence provided by the manufacturer.

Documents prepared in a foreign language must be submitted with a certified translation into Russian.

Expert Insight from UCEC Quality LLC: one of the most important checks before submission is consistency across the entire document package. The medical device name, intended purpose, models and versions, accessories, technical characteristics, regulatory documentation, technical documentation, and operating documents should not contradict one another. If the application and supporting documentation do not meet the procedural requirements, the testing organization may be unable to accept the testing application.

How Long Does a Medical Device Technical Testing Application Review Take in Russia?

The testing organization has up to 10 business days from receipt of the application and documents to decide whether testing can be performed. The applicant must be notified of the decision within three business days.

If the application is accepted, the next steps are preparation and approval of the technical testing program and preparation of the draft testing agreement. If testing cannot be performed, the notification must state the reasons.

When Can a Testing Organization Decline Medical Device Technical Testing in Russia?

A technical testing application may not proceed for one of two basic reasons: either the testing organization cannot perform the required work, or the application package does not meet the procedural requirements.

Problems on the testing organization's side may include:

• the required work falling outside its accreditation scope;
• malfunction of equipment required for the testing;
• scheduled work affecting equipment needed to perform the testing.

Problems with the application may include:

• an application that does not meet the established requirements;
• a supporting document package that does not meet the technical testing requirements.

The applicant must be notified in writing within three business days after the decision is made. Importantly, the testing organization must explain why the testing cannot proceed. A general statement that the work cannot be performed is not sufficient; the specific grounds must be identified.

Expert Insight from UCEC Quality LLC: the risk of problems at this stage can be reduced by checking both the testing organization and the document package before filing. This includes confirming that the organization has the appropriate accreditation scope and technical capability and that the documentation meets the applicable requirements.

How Long Does Medical Device Technical Testing Take in Russia?

The standard technical testing period is up to 30 business days. In cases where the applicable testing method or methodology requires more time, the testing period may be extended by up to 20 additional business days, bringing the possible testing period to as much as 50 business days.

The 30-business-day period does not simply start when the application is filed. It begins after the medical device and the required accessories and equipment have been provided. Where necessary, software or test databases must also be supplied, and the testing work must be paid for under the agreement.

The additional 20 business days are not automatic. An extension is allowed only when the testing method or methodology itself requires a longer duration. If the testing period is extended, the applicant must be notified within three business days after the decision.

For a foreign manufacturer planning a registration timeline, it is therefore important to distinguish between application review time and the technical testing period itself.

What Document Confirms the Results of Medical Device Technical Testing in Russia?

From September 1, 2026, successful completion of this stage is documented in a technical testing protocol. For an IVD medical device, the applicable protocol is issued for the IVD technical testing.

This is one of the clearest procedural changes under Order No. 421n: under the previous rules, technical testing results were documented in an assessment act instead.

Order No. 421n provides a recommended format for the protocol. The document records information about:

• the testing organization;
• the manufacturer or its authorized representative;
• the medical device;
• the documents submitted for testing;
• the procedure and testing conditions;
• the testing methods used;
• the results of the assessment.

The protocol is the document used to confirm the results of technical testing under the new procedure. It may be issued either on paper or as an electronic document.

Which Rules Apply to Technical Testing Applications Submitted Before September 1, 2026?

If the technical testing application was submitted before September 1, 2026, the testing is completed under the previous procedure. The relevant date is the application submission date, not the date when the device samples were transferred or when the final testing document was issued.

Applications submitted on or after September 1, 2026 are subject to the new procedure.

Medical Device Registration Support in Russia

Technical testing remains an important part of conformity assessment for medical devices undergoing state registration in Russia. From September 1, 2026, manufacturers need to account for the new result-document format, application review procedure, reasons why testing may not proceed, revised rules for extending testing timelines, and the separate treatment of certain IVD products.

Unified Center of Expertise and Certification (UCEC Quality LLC) supports manufacturers with medical device registration in Russia. Our specialists can help determine the required scope of testing, review the documentation, identify a testing organization with the appropriate accreditation scope, and help prepare the medical device for the registration process.

Planning to register a medical device in Russia? UCEC Quality LLC can review your documentation, determine the required scope of testing, and help you prepare for registration under the current requirements.