The procedure for providing advice on issues regarding the procedures relating to the state registration of medical devices

Pepeliaev Group advises that a new document has been adopted in the area of the state registration of medical devices

The order that determines the procedure for providing advice with respect to issues concerning the procedures relating to the state registration of medical devices[1] (‘Order No. 6478’) was adopted on 19 July 2017 by the Federal Service for Surveillance in Healthcare (known in Russia by the abbreviation 'Roszdravnadzor') and published on the official legal portal on 30 August 2017.

The key points of the document

Order No. 6478 provides that the Federal State Budgetary Institution (FSBI) ‘All-Russian Scientific, Research and Test Institute of Medical Equipment’ under 'Roszdravnadzor’ and the FSBI ‘Centre for Monitoring and Clinical and Economic Expert Examination’ under 'Roszdravnadzor’ will advise developers, manufacturers (producers) of medical devices or their representatives (the ‘applicants’) on issues concerning the procedures relating to the state registration of medical devices.

The specified authorised institutions provide such advice orally or in writing by virtue of a fee-based services agreement and of the corresponding application in accordance with the form provided in Annex No. 1 to the Procedure.

If information delivered by the applicant for the purposes of obtaining advice is commercially sensitive or any other privileged information protected by the law or is confidential, the official of the institution which provides advice is obliged not to divulge such information and not to use it for personal purposes. Such information may not be provided by the institution to third parties (including officials of Roszdravnadzor) and state authorities.

An institution must provide oral advice within premises that are specially equipped, with audio and video recordings being made that are to be stored for the next 5 years. Copies of such records may be provided to the applicant based on a written request to that effect.

It has been established that the institutions must provide advice within not more than 20 working days from the date when the relevant agreement was concluded.

According to the procedure the FSBI ‘All-Russian Scientific, Research and Test Institute of Medical Equipment’ and the FSBI ‘Centre for Monitoring and Clinical and Economic Expert Examination’ advise applicants regarding the following areas:

• on issues relating to a medical device and the relevant documents being developed, and the procedure for tests (research) to be performed that are required for the state registration of medical devices;
• on issues relating to the documents being developed, and the procedure for tests (research) to be performed that are required for changes to be made to the registration certificate of the medical device;
• on issues relating to the documents being developed, and the procedure for tests (research) to be performed that are required for changes to be made to the documents contained in the registration file of the medical device;
• on issues relating to a device being classified as a medical device;
• on issues relating to a medical device being classified in accordance with the Nomenclature System for Medical Devices approved by order No. 4n of the Russian Ministry of Health dated 6 June 2012 (as amended by order No. 557n of the Russian Ministry of Health dated 25 September 2014).

Special limitations are determined for officials of the institutions: it is directly prohibited for them to advise on a number of other issues: providing clarifications regarding the legislation on the circulation of medical devices, assessing or forming registration files, checking whether the data in registration documents is complete and accurate, providing other advice on issues not set out in the Procedure, etc.

The document specifies that the above advice does not involve an expert opinion, including a preliminary expert opinion, with respect to the quality, efficiency and safety of a medical device and the procedures for which state duty is payable.

The FSBI ‘All-Russian Scientific, Research and Test Institute of Medical Equipment’ and the FSBI ‘Centre for Monitoring and Clinical and Economic Expert Examination’ will keep a special electronic register of medical devices regarding which advice is provided. The above institutions will enter into the register information regarding the name of a medical device, the applicant’s data (its name and location), data on the institution and the official providing the advice, details of the agreement with the applicant, the questions put to the institution, and the timeframes and the result of the advice that was provided. The data in such register is supposed to be available to Roszdravnadzor and to both of the institutions.

The institutions will determine the fee for advising in accordance with the calculation method set out in Annex 2 to the Procedure and will place the fee on their official web sites.

Obtaining advice is not mandatory for a medical device to be registered.

What to think about and what to do

The players on the market of medical devices, especially manufacturers and the developers, should read this document. If clarifications are needed regarding issues concerning the procedures for the state registration of a medical device, the players on the market of medical devices should use the opportunity to obtain official clarifications from the authorised institutions of Roszdravnadzor.

Help from your adviser

Pepeliaev Group's lawyers provide comprehensive legal support with respect to any activities relating to the registration of medical devices, including when obtaining advice from expert institutions.