*The EAC certifications are issued by independent EAC certification bodies and their laboratories accredited by the relevant agencies of the five members of the EAC Economic Union: Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan. The quality assessment, followed by the awarding of the necessary EAC certification, allows access to the markets of the 5 members of EAC certification system. The legislation does not provide any discrimination between goods produced within or outside of the EAC certification area.
MDRC assists medical device companies worldwide with classification, registration, representation and distributor qualification in Russia as shown below.
ROSZDRAVNADZOR maintains a large list of medical devices, and each product on this list has a corresponding code that determines its classification (Class I, IIa, IIb or III). Selecting the proper classification code is critical to ensuring a smooth registration process. Our team has a lot of experience with medical device classification.
There are numerous standards that should be taken into consideration while preparing a ROSZDRAVNADZOR registration dossier for a medical device. The list of documents required for the regulatory submission is set forth in the Medical Device Registration Rules (Government Decree No. 1416). To organize and structure the documentation you need to address the The Technical and User Documentation Requirements for Medical Devices (MOH Decree No. 11), GOST R 51088-2013 for in vitro diagnostic medical devices, GOST R 51352-2013 - Medical Devices Investigations and Trials, and a number of other Russian standards.
Our Russian team will advise you on device labeling requirements and aid in document translation into Russian, as required by Russian law.
Foreign companies are required to have a local representative to act as liaison with ROSZDRAVNADZOR. The representative should also control the registration of the device. We can act on your behalf as your authorized representative. Or we can find an authorized representative that will satisfy your needs and specifications.
We can help find and qualify the best distributors that will be a good match for you to maximize your sales in Russia. Also, we will make sure that your distributors meet all requirements applicable to medical device distributors in Russia.
| Validity | Registration does not expire |
| Language | Documents and Labeling must be in Russian |
| Postmarket Surveillance | Authorized representative must report adverse events and device recalls. |
| Expected Time | Registration of the devices that do not require clinical investigations takes about 6-7 months. If the Russian regulator requires clinical investigations and review of clinical data, the registration takes up to 15 months. |
*The EAC certifications are issued by independent EAC certification bodies and their laboratories accredited by the relevant agencies of the five members of the EAC Economic Union: Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan. The quality assessment, followed by the awarding of the necessary EAC certification, allows access to the markets of the 5 members of EAC certification system. The legislation does not provide any discrimination between goods produced within or outside of the EAC certification area.
MDRC assists medical device companies worldwide with classification, registration, representation and distributor qualification in Russia as shown below.
ROSZDRAVNADZOR maintains a large list of medical devices, and each product on this list has a corresponding code that determines its classification (Class I, IIa, IIb or III). Selecting the proper classification code is critical to ensuring a smooth registration process. Our team has a lot of experience with medical device classification.
There are numerous standards that should be taken into consideration while preparing a ROSZDRAVNADZOR registration dossier for a medical device. The list of documents required for the regulatory submission is set forth in the Medical Device Registration Rules (Government Decree No. 1416). To organize and structure the documentation you need to address the The Technical and User Documentation Requirements for Medical Devices (MOH Decree No. 11), GOST R 51088-2013 for in vitro diagnostic medical devices, GOST R 51352-2013 - Medical Devices Investigations and Trials, and a number of other Russian standards.
Our Russian team will advise you on device labeling requirements and aid in document translation into Russian, as required by Russian law.
Foreign companies are required to have a local representative to act as liaison with ROSZDRAVNADZOR. The representative should also control the registration of the device. We can act on your behalf as your authorized representative. Or we can find an authorized representative that will satisfy your needs and specifications.
We can help find and qualify the best distributors that will be a good match for you to maximize your sales in Russia. Also, we will make sure that your distributors meet all requirements applicable to medical device distributors in Russia.
