This document is issued for a Medical Device or equipment that is used in medical sphere. Registration certificate is issued by Federal service for surveillance in healthcare (Roszdravnadzor) and confirms that the Medical Device conforms to all applicable medical regulations and standards, passed all tests intended for it and is and approved for use and circulation on the territory of the Russian Federation. Without such registration, devices and equipment cannot be used in healthcare.
Medical devices produced in Russia, as well as imported Medical Devices are subject to Registration, including apparatus, instruments, software, systems, devices, equipment, tools, suture and dressing materials, dental tools and materials, sets of reagents, control materials and standard samples, calibrators, consumables for analyzers, products made of polymeric, rubber and other materials, which are used for medical purposes separately or in combination with each other and which are intended for the prevention, diagnosis, treatment of diseases, rehabilitation, medical procedures, research of a medical nature, replacement and modification of parts of tissues, human organs, recovery or compensation of disrupted or lost physiological functions, conception control.
Registration certificate is issued only on basis of successful test results and expertise, during which the quality, safety and efficiency of products and equipment is examined.
We perform all stages of this registration process. Tight cooperation with ROSZDRAVNADZOR, ROSPOTREBNADZOR, expert organizations, clinical, testing labs allows us to offer “one stop shop” service.
For registration, the applicant provides a list of documents on his products, which necessarily should be in Russian or should be translated and notarized.
The term of registration certificate issuance is 7-9 months (depends on medical device type)
years of successful work