Factory audit during registration process and amendments became a reality not only in EAEU regulation but in national registration system for medical devices too. Our
MD Regulation
FAQ about MD registration
QMS inspection of medical device manufacturers
Factory audit during registration process and amendments became a reality not only in EAEU regulation but in national registration system for medical devices too. Our
MEDICALDEVICES
The first list of type codes under Decree No. 552 has been published
On the website of the Federal Service Rosddravnadzor, the first list of type codes to the Decree of the Government of the Russian Federation No. 552
National System prolongated until the end of 2022
National registration system for medical devices in Russia (general registration by Order 1416 from 27/12/2012) is prolongated until the end of 2022 as well as
POC testing. Definition
Point-of-care testing devices Point-of-car (POC) diagnostics becomes increasingly popular in nowadays medicine. In Russia, there is no exactly corresponding technical article, however one can’t say
Registration of medical devices in Uzbekistan.
The main legislative act regulating the procedure for state registration of medical devices is Resolution No. 213 dated March 23, 2018 “Regulations on the procedure
ROSZDRAVNADZOR
How to find out if a medical device is registered or not?
Registration certificate (RC) is a document that confirms that a medical device can be used on the territory of the Russian Federation. The executive authority
Roszdravnadzor – how to use authority website?
The Federal Service for Surveillance in Healthcare (Roszdravnadzor) belongs to the executive authorities and performs control and supervisory functions in the field of organizing and
Free consultations (products intended to be used for coronavirus infection diagnostics)
Since March 20, 2020, due to the need to take measures for the non-proliferation of the Coronavirus infection (2019-nCoV), the Federal Service for Surveillance in
First registration certificate under EAC MED mark
First registration certificate under EAEU regulation was issued in the end of December 2019: registration certificate is in action inside Russia and Kyrgyzstan, for medical
This Laboratory Services and Confidentiality Agreement is signed between the Pharmacopeial Convention of the USA and FGBU IMCEUAOSMP of Roszdravnadzor
On October 8, 2018, during the XXth Annual All-Russia Conference with International Participants “State Regulation of the Circulation of Medicinal Drugs and Medical Devices –
Changing in Regulation for medical devices – the biggest from 2013
Amendments for Order of Russian Government 1416 were done – and this 4th issue is the most significant from 2013 year. Main ideas: IVD registration
Fines for violations
The Regional Dental Health Centre of Vladimir Oblast fined 200,000 roubles for violations identified by the Federal Service for the Supervision of Public Health and
Attention, medical organizations and private entrepreneurs!
As of December 12, 2017, resolution of the Government of the Russian Federation as of 18/12/2016 No. 1327 shall enter legal force, in accordance with