Regulations on safety and adverse reaction reporting for medical devices in CIS

1. 5 QUESTIONS about safety reporting for medical devices
in CIS region
What ?
information must be reported
Why?
(based on what regulations)
When?
(deadlines)
How? Where?
to report
1.Adverse reactions not mentioned in IFU.
2.Undesirable events during usage of
medical device.
3. Facts and circumstances endangering
life or health of patients and health
professionals.
4.Information on interactions with other
medical devices.
-Art. 96 of the Federal Law
323-FZ On Public Health
Protection .
-Order # 12N of MoH dated
20.06.2012.
-Letter from
Roszdravnadzor #4И-
1311/12 dated 28.12.2012.
20
days
-Form to complete.
-Internet system
http://db.roszdravnadzor.ru/
Federal Service on Surveillance in
Healthcare (Roszdravnadzor)
Slavyanskaya sq.4 bld.1
Moscow, 109074,Russia.
http://roszdravnadzor.ru
pharm@roszdravnadzor.ru
Any revealed adverse reactions, defects
and non-conformities.
art. 39 of the the Law of
Belarus “About Health
Care” № 2435-XII.dated
18.06.1993.
-Letter from MoH #11-
15/827-528
dated10.07.2013.
10
days
-Form to complete. Center for Examinations and Tests
in Health Service.
Tovarishesky sidestreet 2a
Minsk, 20037, Belarus.
http://rceth.by
Medquality@rceth.by
Any information that became known or
reasonably should have known that
circulating products presents risks to
consumers.
Resolution of the Cabinet
of Ministers of Ukraine №
1401 dated 26.12.2011.
2
days
-Letter
( in arbitrary form)
State Inspectorate for Quality Control
of Medicines.
Peremohy Avenue 120,
Kyiv, 03115,Ukraine.
http://www.diklz.gov.ua
diklz@diklz.gov.ua
Current Kazakhstan regulations do not contain any specific requirements on safety reporting for medical devices,
anyhow, according to art.84 of Code of Public Health, circulation of a medical device could be suspended or stopped by
competent authority in case of detection data on possible risk for public health.
National center of medicines, medical
devices and medical equipment
expertise.
Abylay khana avenue,63
Almaty, 050004,Kazakhstan.
http://dari.kz
pdlc@dari.kz
BEL
RUS
UA
KZ
Slide prepared by Alexey Stepanov for www.medicaldevicesinrussia.com August 2014