Regulatory changes and modifications for registered products in CIS

1. February 2015
www.medicaldevicesinrussia.com
Regulations of Changes and Modifications to a Registered
Medical Device across CIS region:
Amendment: this separate procedure (which is shorter and less complicated than full registration
process) is possible in Russia and Kazakhstan. Changes are approved as soon as MoH issues the new
registration certificate. For Russia, official time required is 20 business days, for Kazakhstan – up to 60
business days depending on safety class. For Belarus, any amendment in the registration dossier requires
re-registration procedure. The amendment procedure is described in detail in the Russian Medical Device
Registration Rules ( #1416 dated 27.12.2012, clause 37), the Kazak Medications and Medical Device
Registration Rules #736 dated 18.11.2014), and Belarusian Medications and Medical Device Registration
Rules (#936 dated 18.10.2012, clauses 19, 32-37).
Notification: this procedure is described in detail in the Russian Medical Device Registration Rules (#
1416 dated 27.12.2012, clause 55). For this type of changes, the registration certificate remains the same,
but changes notification letter must be submitted by registration holder. Changes are approved as soon as
they are confirmed by special letter of the Regulator. Official time requires is 30 days, which could be
prolonged by 20 business days period for expertize.
Re-registration: this is a new full cycle registration process.
What has been changed? What is the procedure required?
Russia Kazakhstan Belarus
 Name of legal manufacturer
or manufacturing site:
Amendment Amendment Re-registration
 Name of a local applicant or
authorized representative:
Amendment Not regulated Not regulated
 Brand/medical device name: Amendment Amendment Re-registration
 Modifications and technical
changes in a medical device:
Notification or
re-registration
Amendment or
re-registration
Re-registration
 Address of legal
manufacturer or
manufacturing site:
Amendment Amendment Re-registration
 List of accessories: Amendment Amendment Re-registration
 Indications/contraindications: Notification Amendment Not regulated
 Storage life/conditions: Notification Amendment Not regulated
 Marking/Packaging design: Notification Amendment Not regulated
 Software upgrade: Notification Not regulated Not regulated