Russian Special Batch Registration Framework
The first document issued in Russia is dedicated to the specific aspects of the medical devices` circulation in general and state registration of batches of medical devices. The document is intended to implement additional temporary measures to be applied to address the issues related to the public health emergency and will remain valid until January 1, 2021. The scope of the document covers medical devices intended to be used during military conflicts or emergencies, treating diseases hazardous for public health.
The document contains the list of devices subject to the special regulatory framework introduced by the regulation. In particular, the list includes, inter alia, the following devices:
- Different types of ventilators,
- Tests used to identify the virus SARS-CoV-2 (including antibody tests),
- Systems of artificial blood circulation,
- Isolating and protective devices (including certain models of masks and respirators),
According to the document, the batch registration certificate issued under the regulatory framework described therein will remain valid until January 1, 2021. In order to be allowed to import foreign medical device and market it in the Russian Federation, the manufacturer of the device or its authorized representative shall provide the examination body with the following documents:
- The application for the state registration of medical device drafted in compliance with the Rules of medical devices` registration No. 1416;
- The copy of the document confirming the authorization of the representative of the manufacturer;
- The documents confirming the ownership regarding the particular batch in question;
- Technical documents related to a medical device;
- Operational documentation issued by the manufacturer of the device;
- Photographic images of the device together with the accessories thereto;
- The documents confirming the results of technical evaluation and testing of the device, including toxicological evaluation of the patient-contacting materials, and clinical trials designed and performed in accordance with the applicable rules and requirements;
- Other documents demonstrating the quality, safety, and effectiveness of the device;
- The list of all the documents enclosed.
The documents could be provided either in paper or in electronic form. In a case, if the documents provided in a language other than Russian, they should be accompanied by the certified translation.
At the same time, as it is explicitly stated in the new regulation, the requirements on compliance assessment in the form of technical and toxicological examination could be waived for the devices covered by the scope of the regulation. This exclusion could be applied during the appropriate emergency, while the devices that haven`t passed the aforementioned compliance assessment should be subject to additional state registration in accordance with the applicable regulation.
Russian Medical Device Registration Procedure
The expert body shall review the submitted application within 3 business days and check whether any additional documents needed. Then the expert body issues a recommendation regarding the admissibility of the device (or a batch) for state registration and submits it to the regulating authority. The appropriate conclusion of the expert body should be accompanied by the documents provided by the manufacturer of the medical device during the initial application. Under certain conditions, the expert body can issue a conclusion that a batch in question could not be registered. Such a decision could be made in case if at least one of the following reasons is present:
- There is no evidence demonstrating the compliance with applicable requirements,
- There is no evidence demonstrating the safety of the device in question,
- The quality, safety, and effectiveness (any of) of the device claimed by the manufacturer is not confirmed,
- The risk associated with the use of the device exceeds the potential benefit,
- The particular device in question is not included in the list of medical devices covered by the present regulation and thus subject to exclusion,
- The documents provided by the manufacturer are insufficient.
Upon receipt of the aforementioned conclusion, the national regulating authority – Federal service for surveillance in healthcare (Roszdravnadzor) – shall, within the 3 business days, make the appropriate decision:
- to confirm the state registration of a batch and provide the manufacturer or its authorized representative (the applicant) with the registration certificate, and to enter the information about the batch to the state register, or
- to refuse in registration and provide the applicant with the justified refusal notification.
The certificate of the state registration should include the indication of the validity term, the batch number, and serial numbers of the particular medical devices included in the batch. The Roszdravnadzor also forms a registration dossier including the application for the registration, the conclusion issued by the expert body, the decision made by the regulating authority, and a copy of the state registration certificate.
Additional Exclusions and Flexibilities
The document also describes additional measures to be implemented in order to expand the availability of the medical devices facing a significant increase in demand during the COVID-19 pandemic and public health emergency associated thereto. Such measures include, in particular, the following ones:
- It is allowed to import medical devices that have not been properly registered in the amount reasonably necessary to perform evaluation and state registration.
- It is allowed to market single-use medical devices that have not been properly registered without obtaining approval from the Roszdravnadzor, providing that such devices are included in the appropriate exclusion list and also are properly registered in the country of origin.
The aforementioned flexibilities would remain valid only during the appropriate emergency.
However, the applicant shall duly inform the regulating authority about the amount of the devices imported and provide information about batch codes and serial numbers, manufacturing date, shelf life, and the address the devices are being stored. All medical devices intended to be used multiple times, that are not registered in accordance with the applicable regulation, should be destroyed or removed from Russia after January 1, 2021. The applicant shall also duly inform the regulating authority about marketing, removing, or destroying medical devices not later than in 5 business days from the day the action has been performed.
The Roszdravnadzor also retains the right to revoke the state registration of medical device batch in Russia in accordance with the appropriate Rules on state registration of medical device registration set forth by Regulation No. 1416.
Summarizing the information provided here above, the new rules introduced by the Government of the Russian Federation are intended to implement special extraordinary and temporary measures aimed at the extension of the availability of vitally important medical devices during the pandemic.
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