ELMAS Ltd. is a leading certification and registration body on the Russian market, with over 10 years of experience in medical device registration and regulatory consulting services for Russia and CIS countries.
With a vast knowledge and experience in Class I, IIa, IIb and III medical products registration in Russia, Kazakhstan, Belarus and Ukraine, ELMAS has proven success in being a trusted partner and experienced service provider to many clients from all over the world, who can always rely on ELMAS expertise, comprehensive consultations and support.
Over the years, ELMAS has successfully built a team of like-minded specialists, who provide high-quality certification, registration and consultation services, which help our clients to obtain direct Market Access for medical products in Russia and CIS countries.
We provide the following services for medical and non-medical products in Russia and CIS countries:
∙ Registration of Class I, IIa, IIb, III medical products (including Dental products);
∙ Registration of pharmaceutical and API products;
∙ Amendment or issuance of duplicate of Registration Certificate;
∙ Clinical testing in authorized hospitals in Russia;
∙ GOST-R approval (for medical and non-medical products);
∙ EAC, RF, Safety/EMC in Russia & CIS, Pattern approval, Authorized representative service;
Official website : http://www.elmas.ru