We offer legislation any medical devices, equipment, accessories in the Russian Federation
Medical devices – these are products subjected to obligatory registration by Roszdravnadzor (Department of Ministry of Healthcare and Social development of Russian Federation) (According to Order № 1416 of 27.12.2012).
Existing legislation of RF provides several obligatory requirements which medical devices and equipment must suit to.
Medical purposes items manufactured on the territory of Russia or imported to Russia for sale must be registered in Russia for further turnover.
Registration procedure
The Russian medical device registration process is complicated. The state registration of medical devices is carried out on the basis of results of technical tests, toxicology studies, clinical trials, is a form of conformity assessment of medical devices with the classification depending on the potential risk of their application, and examination of the quality, effectiveness and safety of medical devices, as well as tests for type approval of measuring instruments (in relation to medical devices related to measuring instruments in the field of state regulation of traceability, the list of which is approved by the Ministry of Health of the Russian Federation).
Obtaining Registration Certificate of any medical device presupposes successful realization of several kinds of local tests:
Technical, EMC tests
Toxicology tests
Clinical trials
Expertise of medical device registration dossier
Essential part of medical equipment registration is their classification by GOST R 51609. Depending on parts amount and building complicity all complicity medical devices are divided to 4 danger classes depending on their potential risk of use in medical purposes
• Class 1 – low risk;
• Class 2a – medium risk;
• Class 2b – increased risk;
• Class 3 – high-risk.
Company Details
- Founded
- -
- Address
- Moscow, Moscow 100103, Ru
- Industry
- Medical Equipment Manufacturing
- NAICS
-
Medical Equipment and Supplies ManufacturingSurgical and Medical Instrument ManufacturingSurgical Appliance and Supplies ManufacturingDental Equipment and Supplies ManufacturingOphthalmic Goods ManufacturingDental Laboratories
- Website
- http://www.regmed-consult.com
- Keywords
- Registration Drugs and Medical devices in Russia, Regulatory Compliance, IVDR, SaMD, PRRC, MDR, EUAR, USFDA, PersonResponsibleFor REgulatoryCompliance.
- HQ
- Moscow, Moscow
Regmed-Consult Questions
Regmed-Consult's website is http://www.regmed-consult.com
Regmed-Consult's LinkedIn profile is https://ru.linkedin.com/company/regmed-consult
Regmed-Consult's industry is
Medical Equipment Manufacturing
Regmed-Consult's top competitors are
Certification And Quality Llc,
Spraybake Limited,
Bonpland Energy,
Pollution Monitors Limited,
Maclin Pumps Ltd,
Automation World Group,
Ints Co., Ltd.,
Conformando Srl,
Hûmaree™,
Arid Bilge Systems.
Regmed-Consult's categories are Medical Equipment Manufacturing
Regmed-Consult's founding year is 2010
