Russia Approves New Administrative Regulation for State Registration of Medical Devices: Order No. 750

The Federal Service for Supervision in Healthcare (Roszdravnadzor) has issued Order No. 750 approving a new Administrative Regulation of the Federal Service for Supervision in Healthcare for the provision of the public service “State Registration of Medical Devices”. The Regulation replaces the previous Administrative Regulation approved by Order No. 3371 of 6 May 2019 and re-organises the registration procedure in Russia, covering applicants, the form of the registration outcome, processing timeframes, documentation requirements, and the circumstances in which registration may be suspended or refused.

The new Regulation was registered with the Ministry of Justice of the Russian Federation on 15 September 2026 (registration No. 88279) and remains in force until 31 December 2028.

Source: Order No. 750 of 19 August 2026 on the State Registration of Medical Devices | base.garant.ru/414924230

1. Legal Basis and Status of the New Regulation

2. Applicants for State Registration

Under the new Regulation, the applicants for the state registration service are the medical device manufacturer and the manufacturer’s authorised representative.

The Regulation also introduces a category-based approach to applicants by business type:

3. Form of the Registration Outcome

The new Regulation makes clear that no separate registration outcome document is issued to the applicant. Once registration is completed, the outcome is evidenced by the entry (регистрационная запись) made in the State Register of Medical Devices.

4. Processing Timeframes by Registration Type

The new Regulation sets administrative processing timeframes for the different registration scenarios, and the changes against the previous Regulation:

5. New Route for Changes to AI Medical Software Documentation

Changes to the registration documentation for medical software employing artificial intelligence (AI medical software) are treated as a separate application category (Category E), with a processing timeframe of 10 working days.

6. Documentation Requirements by Business Type

7. Circumstances for Suspension or Refusal of Registration

7.1 Circumstances in Which Registration May Be Suspended

• the competent authority requires missing documents to be supplemented;

• further information is required from the applicant;

• clinical trial authorisation related procedures.

On receipt of a notification to supplement, the applicant must:

remedy the deficiencies or supplement the documents — in principle within 30 working days; and

submit a response to the request for supplementary information — in principle within 50 working days.

7.2 Circumstances in Which Registration May Be Refused

• the expert body concludes that the relevant clinical trials cannot be conducted;

• the expert assessment concludes that the product cannot be registered;

• the safety and effectiveness data are inconsistent with the registration documentation;

• the changes to the registration documentation cannot satisfy the requirements.

8. Practical Considerations for Companies

For medical device companies planning to enter the Russian market, it is recommended that current registration strategies, authorised representative arrangements and technical documentation preparation be reviewed against the new Administrative Regulation as soon as possible, so that subsequent registration and product maintenance comply with the latest regulatory requirements.