New rules governing marketing authorization
All Medical Devices circulated in the Russian Federation have to be registered. With effect from January 1, 2013, the rules governing registration have changed. The new rules apply to all new applications for registration submitted in or after January 2013 and to devices with registration certificates issued for an unlimited period before the enactment of the new rules.
Medical Devices have to be registered before they can be placed on the Russian market. Registration with the Ministry of Health and Social Development of the Russian Federation (Roszdravnadzor) is the first and most important step in the Medical Device approval process. It can be applied for the manufacturer's or distributor's name. However, if the documents are issued in the distributor's name and the manufacturer changes to another distributor, all certificates will have to be reissued. To avoid this costly and time-consuming process, it is advisable having the documents issued in the name of the Medical Device manufacturer. In this case, distributors will obtain a notarized copy of the registration certificate, permitting them to import and sell the devices in the Russian Federation without encountering any problems.
Step 1: Testing and registration by Roszdravnadzor
Prior to registration, Medical Devices must undergo toxicology, technical, electrical and EMC tests. For these tests, the manufacturers have to send Medical Device samples to Russian accredited test laboratories. If these tests have been successfully completed, the applicant submits the technical dossier to Roszdravnadzor including product description and test results. The test results are reviewed by experts recognised by Roszdravnadzor. In a first expertise, these experts then decide whether and to what extent clinical testing will be necessary. After completion of the clinical tests all test results are evaluated. If the Medical Device is considered safe, the Russian authority issues a registration certificate with unlimited validity and records the new device in the national register of Medical Devices. Registrations can be accessed in Russian on the Internet from a public database on Roszdravnadzor's website (see "More information").
Step 2: Declaration of conformity
In step 2, a declaration of conformity issued by a Russian accredited certification body must be obtained for the Medical Device. The declaration of conformity can only be issued to companies located in Russia (generally a distributor or a subsidiary of the manufacturer located in the Russian Federation). The declaration of conformity confirms that the Medical Device complies with all applicable technical requirements and GOST-R standards. The registration certificate and the declaration of conformity are mandatory export documents required by the Russian customs authorities.
Deadline for changing of Registration Certificates with the unlimited validity was extended until January 2017!
The new registration rules, i.e. Decree № 1416 of December 27, 2012, came into effect on January 1, 2013. They apply to all applications submitted in or after January 1, 2013. Registration certificates with a limited term of validity issued before this date need not be changed. However, all registration certificates that run for an unlimited period and were issued before December 31, 2012 must be reissued. The corresponding application form can be found on Roszdravnadzor's website (see "More information"). The previous decision from the authority regarding deadline of January 2014 for reregistration of existing registration certificates with unlimited validity has been canceled by Roszdravandzor on July 2013 and extended to January 2017.
Contact: Alexander Schapovalov
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