In August 2023, Government Decree (GD) No. 1332 was published, containing information on changes to the Regulation on Maintenance Licensing (ML) of Medical Devices (GD
MD Regulation
FAQ about MD registration
How can you find the list of pharmaceutical substances and registration certificates of medicines on the Roszdravnadzor website?
Registration certificate of a medicine is a document confirming the fact of state registration of a medicine. Pharmaceutical substance (PS) – a medicine in the
MEDICALDEVICES
PMA dossier for the 3rd class medical devices.
One of the articles in the US medical device registration section was devoted to the PMA (premarketing approval) procedure. As part of this procedure, a
Fluorescence in situ hybridization – FISH test
In Russia, there is a risk of disappearance of tests for genetic breakdowns and oncological diseases. According to information from some laboratories, there is a
Changes in Government fees during custom clearance of medical device samples
With reference to the current economic situation, in April two resolutions of the Council of the Eurasian Economic Commission were adopted, namely No. 46 dated
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
ROSZDRAVNADZOR
First online factory audit under EAEU regulation
For the first time, the Federal Service for Surveillance in HealthCare is conducting remote inspection of medical device manufacturing located abroad. The FGBU VNIIIMT of
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
The Federal Service for Surveillance in Healthcare stopped the implementation of unregistered medical devices, as well as the carrying out of illegal plastic surgeries, at the specialized exhibition of the beauty industry “INTERCHARM Professional” in Moscow
On 19 April 2019 the territorial body of the Federal Service for Supervision in Healthcare in Moscow and the Moscow region, together with law enforcement
As a result of joint actions by the Federal Service for Supervision in Healthcare and law enforcement agencies in the Orenburg region, illegal activities to manufacture and market an unregistered medical device were stopped.
As a result of control and supervisory measures the territorial body of the Federal Service for Supervision in Healthcare in the Orenburg region exposed the
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