Registration of medical appliances and equipment
The current legislation of Russia requires the registration of medical equipment used on the Russian territory in hospitals, healthcare centres, clinics and other institutions. Roszdravnadzor monitors and manages all issues related to the process of registration of such equipment.
A registration certificate serves as the document authorizing the legal use of medical appliances or equipment; the certificate is valid for an indefinite period. The certificate is issued after the Roszdravnadzor experts examine the set of documents submitted by the applicant and all required tests and trials are carried out.
Our experts will assist you in getting all the documents necessary for the state registration ready in a short time and will provide technical and legal follow-up of the entire procedure up to the final stage when the registration certificate is issued. This allows the client cutting down the time and costs considerably.
After a registration certificate is obtained, the owner of the medical appliances or equipment should apply for a declaration for the appliances/equipment to be able to use them legally.
Special requirements for foreign-made medical appliances
A significant part of medical appliances used in Russia have been manufactured abroad. To register such equipment, its owner should submit a file including the following documents:
- an application on the applicant’s letterhead;
- an inventory of the documents submitted;
- a comparative table of the features of the equipment for registration and those of similar Russian-made equipment;
- an extract from the specification with full product data (name, purpose, parameters, features, image, etc.);
- set of documents containing the information on the applicant’s official incorporation in Russia as a legal entity, as well as documents confirming the official incorporation of the applicant in their country of origin;
- notarized powers of attorney authorizing our company to represent the manufacturer’s and the applicant’s interests during the medical products registration process;
- official certificates and documents confirming the compliance of the medical product to be registered with national and international quality standards;
Technical trials of the foreign-made medical devices requires a special set of documents. Our experts will save you this complicated work and will contact the laboratory and promptly draw all the protocols of technical trials, electrical safety trials, electromagnetic compatibility and toxicity tests.
In addition, the applicant has to submit a payment order confirming the payment of the state duty for state registration and safety test.
Registration of Russian-made medical devices
To register medical devices manufactured in Russia, it is required to present certain documents, too. Besides the application, inventory, comparative table and extract listed above, the applicant must submit to Roszdravnadzor the following documents:
- copy of the technical specification of the manufacturer or an agreement granting the right to use a technical specification of a different manufacturer;
- qualification trials protocol.
It should be emphasized that all the documents submitted must be drawn in accordance with the current state standards (GOSTs). If the requirements are not observed, the registration may be refused or the documents may be returned to the applicant for correction. If you resubmit the documents for medical device registration, you will have to pay the state duty again.
That is why it is cheaper and easier to trust the documents in the qualified experts’ hands.