Recently, the Eurasian Economic Union (EAEU) approved the medical registration requirements for all Customs union countries (Belarus, Kazakhstan. Russia, Armenia and Kyrgyzstan) that will come into force in 2021. From 2021 all medical devices should be approved in the EAEU system.

As long as the EAEU is not obligatory, the MD manufacturers should take act within the framework of the laws that regulate the registration process of MD in the Russian Federation.

According to the Russian legislation, there are the following risk classes of MD:

• class 1 – medical products with low individual risk and low risk for public health;
• class 2a – medical products with middle individual risk and/or low risk for public health;
• class 2b – medical products with a high individual risk and/or middle risk for public health;
• class 3 – medical products with high individual risk and/or high risk for public health.

There are 3 main test groups:

• • toxicology tests;
  • technical tests;
  • clinical trials.

The Russian partner company is also responsible for all customs clearance procedures on the stage of importing the samples. NH Consulting can act as your local, Russian representative.

Considering the fact that foreign test reports have little value in Russia, you always have to arrange for testing in Russia. This process can take from 8 to 12 months.

In addition, there are strict requirements regarding the technical documentation that must be made in accordance with Russian laws. Our specialists will lead you through all stages providing detailed consultation and continuous support.

Bring your medical device to market with a partner who can help you navigate regulatory requirements for IEC 60601-1, IEC 60601-1-2, MDD, IVDD, and the CB Scheme.

Reach your target markets quickly and cost-effectively with electrical, software and mobile application testing and certification for your medical device.

We fully support the medical device industry to comply with global health and environmental regulatory requirements and restrictions, such as RoHS.

Get to market faster with integrated compliance solutions and a committed team on your side.

Medical device and materials testing including safety assessment through extractables / leachables and bioanalysis supporting all stages of development and manufacturing.

Multi-disciplined teams who provide robust, GCP and ISO 14155 compliant clinical trials for low risk medical devices.

Please sent your requests to: info@nh-consulting.ru

Serves as the model code for the field evaluation of medical electrical equipment (MEE) and medical electrical systems (MES), specifically pertaining to safety from electric shock, fire and mechanical hazards.