We offer to You a service of registration of medical devices as a matter of approving Your medical devices for manufacturing, import, sales and using within the Russian Federation.
The subjects of registration are all medical devices including tools, apparatus, instruments, devices, complexes, systems with software, equipment, widgets, surgical and sutural dressings, dental products, reagents kits, control materials and reference standards, calibrating appliances, expendable materials for analyzers, polymer and rubber or different devices, software for medical purposes, separately or in combinations.
The Registration is realized by the Federal Service On Surveillance In Healthcare (Roszdravnadzor) on the base of proper tests results and evaluations confirming the quality, efficiency and safety of devices. The Registration of medical devices is approved by the document that called the Registration Certificate. The Registration Certificate’s period of validity is limitless.
We’ll be glad to consult You and provide cooperation while resolving any problem.