In addition to new regulations implemented earlier last year, the regulatory system in Russia is poised for a fairly significant update with the expected implementation of the “Administrative Regulations of the Federal Service on Surveillance in Healthcare and Social Development,” which would repeal the existing framework laid out in Decree No. 735 of 2006.

Declaration of Conformity Replaces GOST-R Certification

Early in 2011, following the provisions of Russian Federation Decree No. 906, GOST-R certification has been replaced by the requirement for a legally binding Declaration of Conformity to the relevant GOST standards. Along with this change, all foreign manufacturers are required to have an in-country representative (Declarant) in Russia to submit the Declaration of Conformity. This function can be fulfilled by a distributor or an independent non-commercial firm. The Declarant holds the original Declaration of Conformity certificate and assumes responsibility for products on the Russian market. The functional change from the prior system is that the onus for demonstrating quality has shifted from the Gosstandart Certification body to the Declarant.

Although a distributor can act as Declarant for the manufacturer in Russia, there are some disadvantages to such an arrangement. The Declarant maintains significant control over the product in the Russian market, which can lead to problems for the manufacturer if there is ever a falling out with the distributor. Additionally, draft regulations, if implemented, would eventually require an Authorized Representative for foreign manufacturers (in addition to the Declarant) if the Declarant and Authorized Representative are not the same entity. Thus, there is good reason to consider appointing an independent Declarant that could also act as your Russian Authorized Representative.

Prior to this arrangement, an in-country representative was required only for registration submissions, but manufacturers could hold registrations in their own names. As of the implementation of Decree No. 906, manufacturers must have ongoing representation in Russia in the form of a Declarant.

Manufacturers with current GOST-R certificates will be subject to these requirements upon expiration of their current certificates.

Draft Proposal for Regulatory Overhaul

Later in 2011, the Ministry of Health and Social Development of the Russian Federation announced approval of new regulations, Administrative Regulations of the Federal Service on Surveillance in Healthcare and Social Development, which will supersede Decree No. 735/2006 when implemented.

Among the many changes expected when this regulation is implemented, is the requirement for an in-country representative to hold device registrations, similar to the EU Authorized Representative. Currently, manufacturers, although not able to submit registration applications, are able to hold registration in their own names. Under the new regulations, manufacturers would be required to appoint and maintain an ongoing relationship with a Russia Authorized Representative.

Although an implementation timeline has yet to be announced, manufacturers doing business in the Russian Federation may wish to prepare for the coming changes by identifying qualified partners to act as Authorized Representatives.

Conclusions

The expected regulatory changes should provide a clearer, more harmonized system in which to do business in Russia and, in the long-term, will likely ease the regulatory burden on manufacturers somewhat compared to the current system.