Verified email-pattern data for Regmed-Consult is currently limited. You can still use the company insights and contact sections below.
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
- 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
Conformando Srl,
Maclin Pumps Ltd,
Pollution Monitors Limited,
Arid Bilge Systems,
Automation World Group,
Certification And Quality Llc,
Spraybake Limited,
Hûmaree™,
Bonpland Energy,
Ints Co., Ltd..
RegMed-Consult's categories are Medical Equipment Manufacturing
RegMed-Consult's founding year is 2010
Explore related pages
Related company profiles:
Free Chrome Extension
Find emails, phones & company data instantly
Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Aero Online
Your AI prospecting assistant
Select data to include:
Total price:
$0.00
0 records × $0.02 per record
How It Works
Get a Free Account
Sign up for a free account. No credit card required. Up to 10 free credits.
Search the #1 Contact Database
Get contact details of over 750M+ profiles across 60M companies – all with industry-leading accuracy. Sales Navigator and Recruiter users, try out our Email Finder Extension.
Use our AI-Powered Email Finder
Find business and personal emails and mobile phone numbers with exclusive coverage across niche job titles, industries, and more for unparalleled targeting. Also available via our Contact Data API.