Registration certificate for medical furniture
Many suppliers of equipment to medical centres consider that the furniture they manufacture is absolutely identical to hospital beds, armchairs, tables, etc. However, this is not so. Order of the Russian Ministry of Healthcare No. 4n dated 6 June, 2012, specifies that medical furniture is classified as accessories and medical products for general hospital use. As the result, a registration certificate is essential for legal use of such furniture; the certificate is issued by Roszdravnadzor upon the completion of the state registration procedure. The only exception to the requirements is medical products made to personal order of a patient due to special requirements of the treatment course. Such products are not subject to state registration.
In all other cases, the procedure for state registration of medical products, including medical furniture, is such as specified by the Decree of the Government of Russia No. 1416 dated 27 December, 2012. The Administrative Regulation for providing this service was adopted by the order of the Russian Ministry of Healthcare No. 737n dated 14 October, 2013. It should not be forgotten that state registration is subject to state duty of RUB 7,000. The amount of state duty for the quality, efficiency and safety tests of the medical products varies between RUB 45,000 and RUB 115,000 depending on the product class.
Registration of foreign-made medical furniture
Registration of foreign-made medical products is allowed only Roszdravnadzor has sanctioned the import of sample products to the Russian Federation. The import procedure was adopted by the Order of the Russian Ministry of Healthcare No. 7n dated 15 June, 2012. If the decision of the authorized agency is positive, the samples of foreign-made medical furniture may stay in Russia during six months with the aim of obtaining a registration certificate for them.
Roszdravnadzor decides on the possibility of medical products import based on the applicant’s request. The request should contain full information on the item itself, on its manufacturer and the manufacturer’s authorized representative.
All documents must be submitted in Russian and documents which have been translated into Russian must be duly certified. The final decision regarding the possibility of medical furniture import is made within five days.