In these economic times where internationalization is a survival need for Italian companies, it is natural to focus on the most interesting and potentially profitable markets. An initial evaluation is often referred to the so-called BRICS countries, the five main emerging economies : Brazil, Russia, India, China and South Africa.

If we focus on  the  medical sector and in particular on Medical Devices, Russia is definitely a market to be evaluated: it has almost 149 million inhabitants with the highest healthcare per-capita spending  among the BRICS countries. In addition, the Russian Medical Devices market value is estimated at $ 6 billion and the 80% of the Russian medical market is based on import. Thanks to this data, Russia ranks among the twenty most interesting countries in the medical sector.

Let’s find out the five fundamental piece of information we should know to register a medical device (or in vitro diagnostic Medical Devices) in this country.

1.Like all economically interesting countries, the market does not lack barriers or entry constraints. For this reason, a registration procedure for all risk classes devices is required. This procedure is quite demanding, mainly due to January 1st, 2013 regulatory changes. Besides needing to submit a complex registration dossier, testing on Medical Devices to be registered in Russia according to the country standards is required.

2. The Russian governmental entity responsible for registration is the Roszdravnadzor, which controls, approves or rejects registration dossiers. In order to start the registration process, the foreign manufacturer must submit to the Roszdravnadzor, through an authorized local Representative, the dossier including several documents, both of an administrative nature, such as certificates certified copies or statements and of technical nature.

3. Prominent among these are  the STED for complexity and commitment required. This is the acronym of Summary of Technical Documentation, that is a particular document summarizing technical and process information regarding the device to be registered.

4. As already mentioned, a local subject should be appointed to follow the registration. This person should be experienced and well-informed enough to easily and smoothly monitor the registration procedure. Since the Regulation often changes, this is not the only subject established in Russia that a foreign manufacturer must appoint. In accordance with the “Government Resolution 2012 N.1416” which recently entered into force, it is mandatory to appoint also an Authorized Representative responsible for the post-market surveillance in order to maximize the consumer protection. Therefore, this subject is responsible for several post-market phases obligations , such as:

  • Device conformity and certification verification;
  • Post-market data collection (claims, market reporting) by organizations and/or private bodies for reporting activities in the Russian Federation and supporting competent Authorities communication (Roszdravnadzor e Rospotrebnadzor);
  • Supporting foreign manufacturers for reporting activities in the Russian Regulation requirements provided relating to incidents occurred in the reference territory (incidents notifications management/near-miss incidents);
  • Reference documentation collection and maintenance (for example system certificates , CE certificates, labelling).

The two above-mentioned subjects may coincide, but this is not binding. However, for the various regulatory processes consistency , it is recommended that these two subjects coincide, and that a local distributor is not chosen. Choosing an importer/distributor is certainly cheap and convenient (they usually share expenditures or even the distributor bears the costs), therefore it seems a convenient choice… but you should wonder about the “afterwards”.

For example, the Importer/Distributor who carried out the registration may not submit the original certificate. But you must consider that it is necessary to present at Customs the original or true copy of the registration certificate for each goods shipment. Or if the Importer/Distributor is appointed as Authorized Representative, it may be difficult to expand the commercial network even to other distributors, considering that the first appointed will be responsible for collecting all post-market data and he will be the only reference for that device towards the competent Authority.5.

5. A final reflection: it is recommended to consider carefully the access to the Russian market, an extremely interesting market but it is rather complex to meet its entry requirements . An opportunity seized during a fair can be significant, but it must open up a new depth of reflections, including the evaluation of an independent Authorized Representative appointment  to develop the country business.


For more information, go to Country Russia

Do you want to keep up to date with Thema’s work? Subscribe to our newsletter!


Simona Daidone
QA/RA Specialist