Registration certificate for medical equipment
Legal requirements of the Russian Federation specify clearly and explicitly the procedure of obtaining registration certificates for various medical devices. Roszdravnadzor acts as the key authority in these matters. It is this body that examines the documents submitted by the manufacturer or the applicant and decides on including the medical devices into the state register.
For a medicine or a medical device designed by your company to be used legally in special medical centres and institutions, it should suffice to perform the official registration procedure and have the medical products included in the state register of medical products.
Not all products are successfully registered.
Despite the apparent evident and transparent nature of the registration procedure, not all applicants find their name in the database of registration certificates for medicines and other medical products. The explanation is rather simple: while examining the documents submitted, the Roszdravnadzor employees scrutinise the quality and the completeness of the registration file.Any minor non-compliance with the Decree of the Government of Russia No. 1416 and with the respective legal requirements may result in the documents being returned to the applicant for completion, which delays indefinitely the obtaining of the registration certificate.
The issue can be easily resolved by contracting a company specialized in legal and technical follow-up of the state registration procedure for medical products. Our staff have profound expertise in preparing registration files, and we guarantee a quick registration of your medical products.
Often the representatives of Russian medical centres are at a loss concerning the ways of checking the registration of a particular medical product. Negligent manufacturers and intermediaries often put such medical products to the market that cannot be legally used in Russia as they lack state registration. Such negligence may entail grave problems and sanctions imposed by the regulators, as the check of registration certificates for medical products lies with the organisations that use these products.
We encourage all our partners and clients to regularly update information on the equipment they use through the database of registration certificates for medical products. If necessary, our experts will be ready to carry out the monitoring of the State register of medical products.