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Medical device registration in Russia (registration certificate from Ministry of Health)

Registration process is the main step in legalization of medical devices. Anybody cannot sale, use and export medical device without registration certificate of Ministry of Health in Russian Federation – Registration certificate is a must for medical products.

Registration certificate reports about product quality, safety, reliability and effectiveness and set up the purpose of use as medical device. All trials, testing and expert estimation can be provided only by organizations that have permission from Ministry of Health.

Elmas supports all studies of this process. Close cooperation with Government organizations (Ministry of Health, ROSZDRAVNADZOR, ROSPOTREBNADZOR, expert organizations, hospitals for clinical trials providing, specify testing laboratories) allows us to offer “one window” procedure for our clients.

Elmas has proven contacts and experience in this area. Our experience is a  knowledge of our specialists working more than 15 years in medical registration.

Elmas has the own testing laboratory for the technical trials. STC SAMTES allows providing complete test service for approval of medical devices according to Russian and Customs Union regulations, has a number of authorizations from European Notified Bodies.

Elmas is a reliable partner. We have partners in different countries from USA till Japan. We work for you. We do it every day.

The main scheme of registration process:



For quotation please send a request by email with:

1. Product description (with color photo).

2. ISO 13485 and CE certificate (if you have).

 

The term of registration certificate issuing is 6-9 months (depends from product type).

 

Contact us – info@elmas.ru

Letter’s name – «medical device registration».