Medical devices registration in Russia.
With RedMed.


RedMed gets you sterile and non-sterile medical devices, invitro (IVD) and software with or w/o AI registrations

OVERVIEW


RedMed offers a seamless regulatory support through every step of your devices registration and circulation. With years of expertise, we work for your success in our core market, Russia.


The lead time for the medical devices registration in Russia is 8-15 months, depends on a risk class (1, 2a, 2b or 3) of your device. The heavier the class the longer the registration takes. A factory audit is mandatory since 2022 for all of classes "2a sterile" to "3" medical devices, followed by passing a few device`s laboratory tests. RedMed is good to be your Authorised Representative in Russia to bear all the regulatory affairs load while devices are on the market, as required by the national regulation.

Medical devices registration in Russia, once obtained, is permanent.


What Steps to follow?


Step 1. Initial dossier creation

Our experts will create a comprehensive Technical File, including a Risk Management Extract and an Instruction for Use by local Standards. We also handle the selection of the appropriate VAT code for import taxation, and provide all the necessary information for compliant primary and secondary markings. Our experts ensure your documents meet all of state standards and legal requirements.


Step 2. Necessary tests for devices

There are 3 types of necessary tests to pass: technical, toxicity and clinical. Only Russian test protocols will be accepted by the Regulator.

If your device is AC-powered, then an electromagnetic compatibility test conducted as well. We select you an accredited laboratory and a clinical base, and support the process during the tests, answering questions and providing necessary help with samples.

Step 3. Factory audit

Note: not required for devices of risk classes "1" and "2a non-sterile".
This type of inspection during Russian national registration was introduced only in 2022, for devices of classes 2a sterile, 2b and 3. The Regulator`s dedicated team will check the Quality Management System standards at your manufacturing sites. RedMed does all the preparatory actions before the Regulator`s team visit, and handles the team`s requests.

Step 4. Applying for the registration within the regulator
For devices of risk classes 1 and 2a non-sterile, we apply for the registration right after the tests. For the heavier risk class devices, we wait for the inspection`s final protocol. Before the applying within the Regulator, a quick notarization of the dossier on your side, and state fee payment needed.

Step 5. Getting your permanent Registration Certificate
The regulatory review of device dossiers takes a minimum of 90 days. Once approved and officially issued, we collect the Registration Certificate for your device from the regulator's office. This certificate will be securely held at your Authorized Representative`s.

Step 6. Post-marketing activities & regulatory affairs
Companies manufacturing, importing, and distributing registered medical devices are subject to the Russian Medical Devices Regulation. It defines reporting on adverse effects, traceability of batches, repeated inspection of manufacturing sites, and keeping the devices compliant with the recent legal developments. Your Authorised Representative must conduct all these types of regulatory actions in a timely manner.

The state registration for medical devices in Russia conducted by Roszdravnadzor (Federal Service for Surveillance in Healthcare).
The regulator`s website is roszdravnadzor.gov.ru
Our procedure adheres strictly to the Russian Government Decree N1416, dated 27.12.2012 "On approval of the Rules of state registration of medical devices".

For detailed expenses and process lead time please contact us:

hello@red-med.ru

Registration process in brief:

1. Dossier creation:

techfile, IfU, markings by local standards

2. Payment for tests: technical, toxicity and clinical

3. Factory audit (for 1st-timers of 2a sterile, 2b and 3 class only)

4. Regulator issues

permanent

certificate

Frequently Asked Questions about the medical devices registration in Russia

Q.: Do I need a local Authorized Representative (AR) to complete the registration?

A.: A sole locally-established AR is required. That company initiates the registration process and bears all regulatory load while the devices circulate. Among all, the AR fills customs forms, submits regular reports and answers customers requests. We provide a dedicated service of an Authorized Representative for your hassle-free journey on the market.


Q.: Who holds the Registration Certificate, Manufacturer or Authorised Representative?

A.: The sole owner of the Registration certificate is Manufacturer, and an Authorised Representative stated as a "Holder". The Authorised Representative acts on a basis of Power of Attorney from the manufacturer, and has no rights over the devices withdrawal from the market, updates, amendments, and doesn`t collect commercial information from dealers.


Q.: Our devices are class 2b in a country of origin. Will they be of the same risk class in Russia?

A.: Russia uses 1, 2a, 2b and 3 classification of device risks. After we explore your documents and find a right codification for the devices within the National registry, our experts define an exact risk class. In most of cases it remains the same, yet sometimes a higher risk class applies.


Q.: What are VAT rates for devices like?

A.: Import rates in Russia are 0%, 10% and 20%, and devices` groups migrate regularly between these rates. Keeping VAT rates low or non-existent is crucial for business models, and we help our clients keeping up with legal developments in the medical devices VAT.


Q.: Is there any kind of express registration for FDA, EC or UK, Japan, Korea-registered devices?

A.: So far, no. Only regular registration process applies. Most of the State Standards in Russia do not necessarily resemble the Standards from the mentioned countries. The same applies for tests protocols: only Russia-originated protocols issued by accredited labs are accepted by the Regulator here.


Q.: How many samples required for the tests?

A.: Legislation in Russia does not outline any minimal and maximal number of samples. Laboratories ask for the samples after checking devices` materials table we provide them with, and usually 1-3 devices of each type requested for tests. After the tests done, we can order a samples return back to the manufacturer.


Q.: What is a samples import policy for tests?

A.: The samples imported only thru Customs, with full clearance as "test samples". No VAT due. The samples must be provided to the Customs together with contracts from laboratories.


Q.: How long does it take to apply updates to the existing Registration?

A.: It depends on a type of the update, and could take either 1-2 months, or, if the update implies heavier changes to existing dossier, up to 12 months. Ask us for more information.


Q.: What are State fees for the registration like?

A.: For the registration only, a 11 000 RUB fee applies for the State Letterhead, in addition to:

class 1 devices - a 72 000 RUB fee;

class 2a devices - a 104 000 RUB fee;

class 2b devices - a 136 000 RUB fee;

class 3 devices - a 184 000 RUB fee

per each Registration Certificate.


For the updates, fees vary from 2 500 RUB to 104 000 RUB.


The fees are paid by your Authorised Representative to the Regulator`s account in Russian rubles.


Q.: What else should I know about the certification of medical devices in Russia?

A.: Starting from 2026, the EAEU standard in registration will be applied - the registrations will be valid in all 5 member states (Russia, Belarus, Armenia, Kazakhstan and Kyrgyzstan), and will take up to 2 years to obtain. Previously issued Russian Registration Certificates will be valid permanently for continuing sales in Russia locally.


For more information in regards of registrations, updates to existing Registration Certificates, testings and QMS inspections, customs and current legal environment, please write us:

hello@red-med.ru

Documents required for medical device registration in Russia:
Technical File Extract: product description, product specifications, the list of applicable standards
Learn more about registrations in countries we operate at:
Azerbaijan Uzbekistan Kazakhstan Kyrgyzstan Tajikistan
Redmed RUSSIA: MOSCOW, Butyrskiy val, 10
+7 495 108-61-49
hello@red-med.ru
red-med.ru
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