Medical Registration Certificate

Medical Registration Certificate

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.

The same classes apply to in-vitro devices which also need to be Registered as MD.
To initiate the MD certification you need a partner (distributor or any other company – resident company of the Russian Federation) which will apply for certification of the product and co-ordinate the testing.

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.

Regulatory Requirements for Medical Equipment
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.

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

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

Medical Management Systems Certification & Auditing
Get to market faster with integrated compliance solutions and a committed team on your side.

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

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

SPE-3000-15
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.

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

Some reasons why you should work with us:

• Active in Russia since 2001
• Dutch owned and Dutch managed
• We speak your language: Russian, English, German, Dutch
• Group companies in Russia, Belarus, Ukraine, Azerbaijan, Kazakhstan, Uzbekistan, Moldova
• Our specialists understand very well the Russian requirements and the international standards
• Our staff is flexible and customer-oriented
• NH Consulting will consult you and offer you the best solution according to your needs
• We will provide you with all necessary assistance and support through our Russian office
• Our staff is friendly and will help you to solve your challenges with pleasure!

We are trusted by international companies since 2001
Please describe in detail which service you are interested in. We are here to support you!
You can place an inquiry through info@nh-consulting.ru to receive an initial consultation.