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How to Register Your Medical Device in Russia

You'll get some insight into what medical device manufacturers need to know before their devices can be imported, sold and used in Russia.

How to Register Your Medical Device in Russia

We interview Matija Rupnik, the Regulatory Affairs Manager at ArrowFast, who shares what medical device manufacturers need to know before their devices can be imported, sold and used in Russia.

The last time we spoke about what manufacturers need to know about the regulations and processes that apply to getting their medical devices into the Chinese market. Today, we are going to address a similar topic but for the Russian market. So, let's start at the beginning.

Which authority handles the registration of a medical device in Russia?

The authority in Russia that handles medical devices is the Federal Service for Surveillance in Healthcare. This is more commonly known as Roszdravnadzor (RZN) and it was established by the President of the Russian Federation on 9 March 2004. It is a federal executive body responsible for control and supervision of the Healthcare system. Roszdravnadzor is subordinate to the Ministry of Health of the Russian Federation and is guided by the Russian Federation Constitution, federal constitutional laws, federal laws, acts of the President of the Russian Federation and State Government, international agreements, acts of the Ministry of Health of the Russian Federation and the Regulation.

What are the main regulations that manufacturers have to be aware of?

If the device satisfies the definition of a medical device (as defined in Article 38 of Law 323-FZ The basis of health protection in the Russian Federation), then the main regulation for Medical Devices is Resolution N 1416 Adoption of rules for state registration of medical devices.

This Resolution is supported and supplemented by other orders and decrees. All medical devices must be registered with the RZN, but there are different requirements depending on the risk class of the device. The risk class of the device is determined to the classification rules in Order 4n, amended by Order 557n and GOST 31508-2012. The risk classes are similar to those in the EU:

  • Class I: medical devices with a low degree of risk
  • Class IIa: medical devices with an average degree of risk
  • Class IIb: medical devices with an increased degree of risk
  • Class III: medical devices with a high degree of risk

Before we get into the details of the registration process, we want to speak about some administrative matters. In China, we saw that an in-country representative was needed. Is the same true of Russia?

Only the holder of the registration certificate can import medical devices into Russia. Therefore, all manufacturers based outside of Russia must designate an Authorized (in-country) Representative.

This Authorized Representative (also called the Declarant) is legally responsible for regulatory compliance and therefore must possess the requisite expertise in the field of medical devices. The Authorized Representative is also responsible for submitting the application for the registration of the medical device, all communication with the RZN and for submitting and maintaining the GOST Declaration of Conformity.

Say a medical device already has a valid CE mark. Will this make it easier to get the device registered in Russia?

Home country approval is not officially required for registration, but it is unofficially required to obtain the import permit necessary to import the product samples for in-country testing, if this is required by the RZN. CE marking or any other home country approval will not be enough to get the device registered however, the device still needs to pass the registration process we discussed earlier.

You’ve mentioned in-country testing. Can you tell us more?

In-country testing and clinical data are required to approve all medical devices, even if the device is already being sold in other major markets. Unfortunately, foreign test reports are not accepted. The tests are done according to the applicable GOST—R standards in accredited Russian test laboratories and the extent of the clinical evaluation is defined based on the review result of the subordinate expert organisation (delegated by the RZN). Additionally, test samples must be provided and these are subject to a special import procedure.

So, what’s the registration process like?

The procedure is slightly different for Class I devices and for Class IIa, IIb and III devices. Class I devices undergo only one review stage, while Class IIa, IIb and III devices go through two review stages. All devices, irrespective of risk class, must submit an Application containing the device description in the Russian language. This documentation is sent to an authorized Russian test laboratory to determine the in-country testing requirements, e.g. technical testing, toxicity testing and clinical trials. Thereafter, manufacturers (or the Authorized Representative) must obtain an Import Permit from the RZN to import the necessary samples for testing and send these to the authorized Russian test laboratory for the testing. For Class I medical devices, the clinical testing is done at this stage.

Once testing is complete, then the Registration Dossier is prepared (in the Russian language) and is submitted to the RZN. The Registration Dossier includes evidence of compliance to the legislation and relevant standards, including all applicable test reports and the supplemental Russian clinical data.

In the Stage I Review (for Class IIa, IIb and III devices), the RZN reviews the completeness of the submitted documentation before delegating a subordinate expert organisation to perform a review and determine the supplemental Russian clinical data requirements. If there are no requests for additional information, the RZN issues permission for clinical testing/trials.

Thereafter, clinical testing or trials are done based on the supplemental Russian clinical data requirements from the RZN. When the clinical testing is complete, the application for Class IIa, IIb and III devices must be resubmitted to the RZN, this time including the clinical test report.

In the Stage II Review, the RZN performs the review in which the Registration Dossier and Clinical test report are assessed (for Class I, IIa, IIb and III devices). If there are no requests for additional information by the RZN, a decision to register the product is made.

If the registration is successful, a Registration Certificate is issued by the RZN. Registration certificates do not expire and are publicly available from the Roszdravnadzor website.

I realize that this sounds a bit complicated, so our team has prepared a PDF where this process is laid out as a flow-chart. You can find it here.

ArrowFast_Medical_Device_Regulation_russia

Is this all that is required to sell the product in Russia?

Not quite… After the registration certificate has been issued, a declaration of conformity, verifying the product’s compliance with the technical requirements of the applicable GOST-R standards, is needed.

The Authorized Representative needs to apply for this GOST Declaration of Conformity (DoC) certification. After the GOST DoC is issued, the device must be labelled with the DoC symbol. The DoC is valid for a period of up to three years. Only then can the medical device be imported, sold and used in Russia.

What about post-market activities?

In Russia, as with elsewhere, manufacturers must perform post-market related activities according to Order N 980n and maintain their DoC certification. Placing a medical device on the market does not mean an end to the manufacturer's activities related to the device, as continuous monitoring, reporting, and improvement are required. Additionally, the quality management system must also be maintained in order to keep the device available on the market.

The declaration of conformity is valid for a period of up to three years. Once a certificate of registration and a declaration of conformity have been issued, the medical device can be imported into Russia and legally placed on the market for sale.

How long can a manufacturer expect the process to take and how much does it cost?

The official timeline for review of the Registration Dossier is 50 days from the date of submission. In practice, a first-time registration takes between 6 and 16 months, and 4 months if there are any upgrades or changes.

For costs, the whole registration procedure (each registration certificate) costs between 5 000 and 20 000 EUR, depending on the type of the medical device.

And these estimates do not take into account the costs associated with document collection, technical file preparation, importation for in-country testing, conducting in-country testing, or securing the GOST Declaration of Conformity ;).

Why is 31 December 2021 important?

At present, it is possible for manufacturers to enter the Eurasian Economic Union (EAEU) market through Russia or any other Member State, but this is only possible until the end of the EAEU transitional period, which ends on 31 December 2021. Thereafter, you'll need to certify the medical device according to EAEU regulations to enter that market.

Thank you, Matija. I’m sure that will be useful to our readers. How can readers get more information?

I tried to cover as much as I could, but of course there are many more details. So, if readers want more information then, they can contact the ArrowFast team at regulations@arrowfast.tech.

Remember, that readers can also download a simplified overview of what is needed to get a medical device approved for import, sale and use on the Russian market.

ArrowFast Team

ArrowFast Team

ArrowFast Team - A group of Medical Device Engineering Specialists

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