Easy to understand chart describes the medical device registration process in Russia.

1. Russia
© 2016 Emergo – Have comments or suggestions about the content of this chart? Email us at marketing@emergogroup.com. Chart updated 07/2016. EmergoGroup.com/Russia
Medical devices in the Russian Federation are regulated by Roszdravnadzor (RZN), under Decree 1416.
Determine classification according to Order 4n and GOST 31508-2012, and identify the nomenclature classification code.
Appoint an Authorized Representative to coordinate your medical device registration in Russia.
RZN conducts completeness review. If acceptable, dossier is sent to an Expertise Center for
technical review. Expertise Center reviews and makes recommendation for supplemental clinical
data requirements*. RZN reviews recommendation and issues final opinion on next steps.
Prepare Registration Dossier including technical information, test results, ISO 13485 certificate,
and existing clinical data. Submit to RZN and pay fees. Most documents must be translated into Russian.
Certificates must be notarized and apostilled. Class I devices are eligible for a simplified review process;
however, the Registration Dossier must include Russian supplemental clinical data*.
Following RZN’s clinical data requirements, conduct additional testing or trials** in Russia.
During this time the registration is placed in “suspended” status. Submit clinical results to
RZN and apply for continuation of the registration process.
Send device information and existing test reports to an authorized test lab in Russia.
The lab determines the in-country testing requirements. Documents must be translated into Russian.
Class IIaClass I Class IIb Class III
Dossier goes through Stage 2 review. If acceptable, RZN issues a Registration Certificate and lists product in
registration database on RZN’s website. Registrations do not expire.
Prepare and submit Import Permit application to RZN to import samples of your device for testing. RZN issues permit.
Appoint a Russian Declarant and apply for Declaration of Conformity (DoC) certification.
DoC certification is a combined quality and product safety certificate. Documents needed may include
Registration certificate, test reports, ISO 13485 certificate, and other documents.
After DoC certificate has been issued, the DoC symbol must be placed on your device.
You are now authorized to market your device in Russia. The DoC certificate is valid for up to 3 years
depending on the manufacturer’s choice.
Send device(s) to authorized test lab in Russia for quality, safety, and efficacy testing.
5039-0716
The Regulatory Process for Medical Devices
* Additional clinical data requirements could include additional testing, hospital evaluation, or full scale human trials in Russia. Russian clinical data reports should be developed according to Roszdravnadzor
guidance document, Order 2n.
** The Russian market is in flux, and certain elements of the law are not defined. Order 2n provides broad criteria for the types of devices that require a clinical study, e.g., devices with novel or complex medical
technologies. If RZN determines your device meets these criteria then clinical studies with human patients will be required. Unfortunately, RZN has not released any guidance document on how to conduct clinical
studies in Russia.
This is a simplified overview of the process. Roszdravnadzor may choose to audit your submission and request more documents, which will add time to your approval.

2. Russia
Notes
1. The time frames shown above exclude the time required to address supplementary clinical data and/or clinical trial requirements. These time frames
are typical for the majority of medical device submissions but assume that your device does not contain animal tissue, medicinal substances or employ
novel technology. This time will depend on the quality and completeness of your technical documentation, as well as how much time you take to address
additional information requests from authorities after submission. YOUR SUBMISSION(S) MAY TAKE MORE TIME THAN WHAT IS SHOWN ABOVE.
2. Device registrations do not expire. However, the Declaration of Conformity (DoC) certificate is valid for 1 or 3 years, according to the preference of
the manufacturer.
3. Device registrations are valid indefinitely. If you make changes to the device, intended use, or indications for use, the registration must go through a
technical review and approval. Significant changes to the device may require a new registration.
4. Our rating of the complexity of the registration process is based on our experience and the opinion of nearly 1,000 QA/RA professionals worldwide who
were asked to rate the difficulty of registering a device in each country. The European CE Marking process is considered the mid-point to which all other
markets are compared.
5. Low = Less than US$5000; Midpoint = US$15000-$30000: High = More than US$50000. Overall cost includes registration application fees, product testing,
in-country representation, submission preparation consulting and translation of registration documents but not IFU. Costs assume you already have
approval for your device in the United States, Europe, Canada or Japan. Does not include costs or time associated with conducting a clinical trial in Russia.
EmergoGroup.com/Russia
Device classification
in Russia 
Class I Class IIa Class IIb Class III
How long you should
expect to wait after
submission until
approval is granted.1
6-10 months 8-12 months 8-12 months 8-12 months
Validity period for
device registrations.2 Does not expire Does not expire Does not expire Does not expire
Registration renewal
should be started this
far in advance.3
Not applicable Not applicable Not applicable Not applicable
Complexity of the
registration process
for this classification.4
Overall cost of gaining
regulatory approval.5
5039-0716
© 2016 Emergo – Have comments or suggestions about the content of this chart? Email us at marketing@emergogroup.com. Chart updated 07/2016.
Time, Cost, and Complexity of Registration
Simple Complex Simple Complex Simple Complex Simple Complex
Low High Low High Low High Low High