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 On 14.08.2012 entered into force the order of the Russian Ministry of Health no. 7n of 15/06/2012, which introduced a new procedure for the import of samples of a medical device for the purpose of its registration with the Ministry of Health. The ministerial order has introduced a special permit for the importation of samples of a medical device, issued by the Federal Service on Surveillance in Healthcare (Roszdravnadzor). It is valid for 6 months and is expendable once.
Before 14/10/2012 importing samples of medical devices in Russia took place without any special permission or document.
The ordinance was approved with the aim of realizing the provisions of art. 38, paragraph 6, of the Federal Law n. 323-LF of 21/11/2011 "On the principles of protecting the health of citizens of the Russian Federation."
Samples of medical devices can be imported into Russia by the manufacturer of the medical device or its Authorized Representative on site, corporate or individual company under Russian law.
To obtain the import permit is required the following documents (information):
1) Name of medical device, list of components and accessories, quantity, serial number, lot or batch number, manufacturing date, expiry date or lifetime;
2) application of the medical device as construction documentation of the manufacturer;
3) information on the applicant (name, legal form, address, registration number in the register of companies, etc.).
3) information on the workshops at which it is expected to test the samples;
4) copy of the contract with the testing laboratories with the specific quantity of samples required;
5) copy of the warrant agreement or with the Representative.
The permit is issued to the manufacturer or to his Representative within 5 days of receipt of the request for release.
An application for permit to import may be rejected for the following reasons:
1) failure to submit the above documentation, or submission of incomplete documentation;
2) passing of an admission fee on the market of the Russian Federation scheduled for a particular type of medical device in accordance with the international agreement or resolution of the Government of the Russian Federation;
3) information obtained from Roszdravnadzor, following an analysis of the market for medical devices, adverse reactions from the use of medical device products not declared in the operational documentation, reports of suspected adverse reactions, information on the compatibility of the medical device with other devices doctors, etc.
On the Roszdravnadzor website is available a database, accessible on-line, with all import permits issued.
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