For small devices that cost may be equal to several hundred dollars. The registration procedure involves several stages such as technical, safety, toxicology, hygienic and clinical tests. Testing centers accredited by the Ministry of Health perform technical and toxicology tests. The Ministry of Health has lately been actively implementing obligatory hygienic testing and obtaining hygienic conclusions for practically all medical equipment and devices. The Department of State Sanitary and Epidemiological Surveillance of the Ministry of Health issues hygienic conclusions.
Measurement devices undergo special tests to prove that they can be used as measurement means.
Clinical tests are performed by healthcare institutions authorized by the Ministry of Health upon completion with positive results of respective technical and toxicology tests as well as hygienic assessment. If a foreign manufacturer performs registration, it has to submit a number of documents to the Russian Ministry of Health. They include the application, technical description of the product, price information, operating instructions in Russian, copies of registration certificates in the country of origin and third countries and others. If registration is performed by an authorized Russian company, it has in addition to the above mentioned documents to submit Power of Attorney from the manufacturer notarized by the Russian Consulate office in the country of manufacture. The applicant covers insurance payments for risks of adverse effects of the clinical tests on test participants.