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is challenging, since it is quite different from established procedures in EU and USA.
The key to understanding of regulatory requirements in Russia for registration of medical devices is independent system of national certification based on testing – technical, toxicological, hygienic and clinical. Unlike registration of medicines, federal institution that performs registration as well as control and coordination of various required tests is the Federal Service for Health Surveillance, or, according to Russian semi-acronym, “Roszdravnadzor.”
If your product already has US 510(k) clearance or European CE certificate, full testing in Russian certified centers is obligatory anyway. The national testing system itself, its strict and national standard (“GOST”) requirements present one of the key challenges for foreign manufacturers during registration. Needless to say that preparation of the dossier that corresponds to Russian requirements can be time consuming.
Shortly, one should take the following
and way of medical use (class I – the safest, then - classes IIa, IIb or III). Appoint authorized representative for both Registration and Import Permit procedure.
for various expertise testing procedures. Prepare technical, quality, toxicology, safety and efficacy documentation along with the samples and file them for testing in corresponding Russian certified centers.
Roszdravnadzor and its Expertise Center reviews the dossier and determine necessity of conduction of local clinical study or additional clinical data.
complete the study in authorized clinical center(s) and apply for continuation of the registration process.
The RC will be valid until variation to the device, manufacturing chain or registration holder should be registered – after variation procedure the RC should be re-issued.
that proves both quality and safety of the device in Russia. After getting the declaration registered, the product can be imported.
Our experts are experienced in specific procedures of medical device testing, clinical studies as well as communicating with different testing facilities and clinical study centers. One should keep in mind current official Russian politics vector of imported product substitution strategy, elaborated by Russian Government.
Excellence in communication with Roszdravnadzor and quality of registration dossier is essential for getting fast and predictable results of a medical device registration or variation project. We are ready to give your business Clear and consistent Regulatory Answers in such challenging field as medical devices regulatory affairs in Russia are.