According to Clause 37 of RF Government Resolution dd. December 27, 2012 No. 1416 "On approval of the rules for state registration of medical devices" (as amended on March 18, 2020) (GR 1416), changes to documents contained in the registration dossier that do not require an examination of the medical device quality, performance and safety include:

a) changing information about the applicant, including that:

• on the legal entity reorganization;
• on change in the legal entity name (full and (if any) abbreviated, including the brand name) and location address;
• on change of the surname, first name and (if any) patronymic name, address of residence of an individual entrepreneur and details of his/her personal identification document;

 b) changing information about the person in whose name a medical device registration certificate may be issued, including information:

• on the legal entity reorganization;
• on change in the legal entity name (full and (if any) abbreviated, including the brand name) and location address, or surname, first name and (if any) patronymic name, address of residence of an individual entrepreneur;

 c) changing the medical device production (manufacture) place address;

d) changing the medical device name in case when either the medical device properties and characteristics related to its quality, performance and safety have not changed, or such properties and characteristics have been improved while its functional purpose and/or operation principle remain unchanged, including:

• addition (exclusion) of the medical device accessories or change in their names;
• indication, change and exclusion of the trademark and other means of the medical device individualization;
• change in the number of the medical device units or its components/accessories specified in the appendix to the registration certificate;
• indication or exclusion of design variants (models) of the medical device;
• change in the labeling and/or packaging of the medical device;

e) the medical device manufacturer (producer) changing validity periods of the documents contained in the registration dossier;

f) changing information about the authorized representative of the medical device manufacturer (producer).

According to Clause 39 of GR 1416, if the introduction of the declared amendments to the MD entails changing its properties and characteristics related to its quality, performance and safety, or improving its properties and characteristics while its functional purpose and/or operating principle remain unchanged, then introducing amendments to such documents shall be based on the results of examination of the medical device quality, performance and safety.

If a registration certificate is damaged or lost, you have the right to apply to the Federal Service for Surveillance in Healthcare (Roszdravnadzor) for issuance of a duplicate of the registration certificate.

Development of technical specifications in accordance with the current legislation requirements of the Russian Federation and the EAEU

Development of the technical documentation on a turnkey basis.

Development of the operational documentation in accordance with the current legislation requirements of the Russian Federation and the EAEU

Requests for testing in various laboratories accredited to conduct testing for the purpose of MD registration. Selection of laboratories with the best price-quality ratio. Registration of applications for testing, sample transfer, processing of requests from laboratories until positive conclusions are received.

Preparation and submission of the dossier to Roszdravnadzor, processing of critical comments at any stage of the examination until the registration certificate is received.

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In accordance with Clause 8 of Order of the Ministry of Health of Russia dd. October 19, 2020 No. 1113n "On approval of the Procedure for reporting by subjects of medical devices circulation on all cases of detection of side effects not specified in the instructions for use or operating manual for a medical device, on adverse reactions during its use, on specifics of the medical devices interaction, on facts and circumstances creating a danger to the life and health of patients and healthcare professionals during the use and operation of medical devices" (hereinafter referred to as the Procedure) for medical devices of potential risk class 3, as well as medical devices of potential risk class 2b implanted into the human body, a manufacturer of medical devices (its authorized representative) is obliged to monitor their safety and clinical performance after their registration (hereinafter referred to as clinical monitoring) and annually, for 3 years, submit to the Service (in accordance with Clause 2 of the Procedure, the Federal Service for Surveillance in Healthcare) reports on clinical monitoring.

Clinical monitoring reports shall be submitted by the manufacturer of medical devices (its authorized representative) by or before February 1, starting from the year following the year of registration certificate receipt.

Analysis of the production process documentation, determination of production sites subject to production inspection, preparing an application for the production inspection procedure, preparation of a set of documents required for preparing and conducting the production inspection, support in eliminating critical comments, if necessary.

The production inspection shall be carried out in the following cases:

• production of medical devices subject to state registration in cases requiring examination of quality, performance and safety, as well as in cases of change in the address of the place of the medical device production specified in the MD registration certificate, except for the state registration of a medical device series (batch) and medical devices registered in accordance with Resolution of the Government of the Russian Federation dd. April 1, 2022 No.552 "On approval of the specifics of circulation, including specifics of state registration, of medical devices in the event of their defects or risk of defects in connection with the introduction of restrictive economic measures against the Russian Federation";
• production of custom-made medical devices which are subject to special requirements of healthcare professionals.