The lack of necessary documents, inconsistencies in the application and the lack of translation into Russian are the most common mistakes that are made when obtaining permission to import medical devices (MI) for the purpose of their state registration. The list of 10 points was compiled by Roszdravnadozor.
The Federal Service for Surveillance in Healthcare has published a list of errors that are most common in documents for obtaining permission to import medical devices for the purpose of their state registration. The list compiled by the service consists of 10 items.
The procedure and regulations for the import of medical devices are regulated by orders of the Ministry of Health (No. 661n dated June 30, 2020) and Roszdravnadzor (No. 11205 dated November 30, 2020). From January 1, 2021, sets of documents required to obtain a permit are sent to Roszdravnadzor electronically through a personal account on the Unified Portal of Public Services.
Typical Roszdravnadzor calls:
errors when filling out the MI package. As an example, the service cites a situation where the equipment and accessories fit into the name of a medical product;
inconsistency of information about the applicant with the data of the Unified State Register of Legal Entities and the EGRIP. The documents incorrectly indicate the TIN, PSRN, PSRNIP, the name of the organization, the full name of the general director;
lack of a power of attorney for the person who signed the application or contract for testing;
inconsistency of data in sent documents. This is a discrepancy between the names, quantities, series numbers, etc. indicated in the application. what is specified in the test contract;
the lack of a Russian-language version of the name of medical devices or imported samples;
expired contract/power of attorney or absence of the date of drawing up the document;
the use of the wording “if necessary” instead of specifying the specific number of samples to be imported;
filing an application in the presence of a previously issued permit for the import of medical devices. The Service clarifies that if it is necessary to import additional samples of MP, the set of documents must contain an explanatory letter, in case of an error when submitting an application, an application for the cancellation of the previous permit;
errors when submitting a copy of the document confirming the authority of the authorized representative of the manufacturer. The problem arises when the applicant submits a document that is not certified in the prescribed manner, or does not provide its certified translation into Russian;
the absence in the document confirming the authority of the authorized representative of the manufacturer of an indication of the possibility of representing interests “on issues of circulation of medical devices on the territory of the Russian Federation”.
In May, the Ministry of Health developed a procedure for importing medical devices into Russia that are not subject to registration. We are talking about MI for the provision of medical care according to vital indications for a particular patient on the basis of a permit issued by Roszdravnadzor. The document may enter into force in September 2021 and will be valid until January 1, 2027.