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 Logistics 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-logistics.com