Medical products registration
Universal Pravo LLC provides comprehensive support for Russian manufacturers and importers of foreign medical products. Our primary activity lies with providing services related to drawing technical, operation and specification documents for medical products, as well as assisting the client throughout the process in accordance with all legal requirements.
Our highly qualified staff, many of them holding an academic degree, provide such services as: drawing product specifications, preparing excerpts from imported products specifications or other documents required by the Decree of the Government of Russia No. 1416 (as amended by the Decrees of the Government of Russia No. 930 dated 17 October, 2013 and No. 670 dated 17 July 2014) specifying the Rules for medical products registration.
Consulting services related to medical products registration
We provide the following consulting services related to medical products registration:
- correction of technical and operation documents;
- finding an accredited laboratory authorized to carry out the required technical tests, check electric safety and electromagnetic compatibility, and check for toxicity of the patient contact materials;
For foreign companies
For our foreign clients we also offer responsible support of the medical products imported to Russia by acting as a foreign company’s authorized representative.
We can assure both several stages and the entire process of obtaining a registration certificate for a medical product.
Medical products production quality management system
Our leading experts will assist you in applying the ISO 13485 standard (quality management system for medical products manufacturing).
Such changes are essential, as from 2021 this ISO standard will become an alternative for the licence for medical devices manufacturing and servicing. In the run-up to this period, it is expected that new quality control measures could be introduced by Roszdravnadzor.
We carefully monitor all the recent amendments to the current legislation, analyse the modifications and, if necessary, submit requests to Roszdravnazor for explanation of certain rules of registration. The information collected allows us making a reasonable conclusion and providing justified recommendations to the suppliers of medical products concerning the conditions of their use in Russia.
Primary consulting by our experts related to requirements for the registration procedures is granted to the client free of charge.
The cost of the paid services is defined based on the analysis of the specifications and technical documents for the product and depends to a large extent on the class of hazard and the number of protocols to be drawn.
Do not hesitate to address our experts.
Visit our office at: Elektrodnyy Proyezd, 8А, office 12, 111123 Moscow
+7 (495) 120-28-36,
+7 (800) 500-34-36 to ask your questions.