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Selling a medical device without a Russian registration certificate: legal aspects and liability
March 3, 2026
The circulation of medical devices in Russia is strictly regulated by the state. The main legal requirement is a registration certificate, which confirms that the product has passed all the necessary quality, efficacy and safety checks. Selling medical devices without a valid registration certificate is a serious offense and results in sanctions for the business.
Legal regulation of medical device sales in Russia
The circulation of medical devices is governed primarily by Federal Law No. 323-FZ of November 21, 2011. It makes state registration mandatory before a medical device is placed on the market. Oversight is entrusted to Roszdravnadzor.
What is a registration certificate
A registration certificate is an official permit issued by Roszdravnadzor. It certifies that the medical device has passed the registration procedure, including an expert review of quality, efficacy and safety, and is approved for use in Russia or in the EAEU.
The certificate contains a unique registration number and information on the manufacturer, intended use and potential risk class. A registration certificate is a prerequisite for lawfully manufacturing, importing, selling and using the device.
The certificate contains a unique registration number and information on the manufacturer, intended use and potential risk class. A registration certificate is a prerequisite for lawfully manufacturing, importing, selling and using the device.
Medical devices exempt from state registration
The law provides a limited list of exceptions. The following may be placed on the market without registration:
- Medical devices for specific patients, made to individual order.
- Equipment or instruments intended for research purposes.
- Certain types of medical devices on a list approved by the Russian Government (for example, simple devices; the list is updated regularly).
Liability for selling medical devices without a registration certificate
Violating the rules for the circulation of medical devices entails several types of liability, which may be applied separately or together.
Administrative liability and fines
The main sanctions for selling unlabeled or unregistered products are set out in the Russian Code of Administrative Offenses. Under Article 15.12, violating product labeling rules is punishable for legal entities by a fine of 50,000 to 300,000 rubles with confiscation of the goods. The authorities may also impose liability under other articles, for example, for conducting business in breach of license conditions (where a license is required). This can lead to fines of up to 200,000 rubles and suspension of operations.
Criminal liability and possible penalties
If selling a medical device without a registration certificate has caused major damage to consumers or the state, or was committed on an especially large scale, criminal liability applies. It is governed by articles of the Criminal Code, for example, Article 238.1 of the Russian Criminal Code (circulation of falsified medical devices). Penalties may include:
- Large fines (up to 1 million rubles or the amount of income for a period of up to 24 months).
- Compulsory labor.
- Imprisonment for up to three years (and up to 10 years if serious harm to health was caused).
Risks and consequences for businesses selling devices without a registration certificate
In addition to fines and criminal prosecution, companies that break the law face a range of other negative consequences.
How the lack of a registration certificate affects tax rates and benefits
Sales of medical devices are exempt from VAT (0% rate) only if one key condition is met: the device has a Russian or EAEU registration certificate. If a medical device is not registered, its sale is automatically subject to VAT at the standard rate (22% from 2026). This increases the tax burden, reduces price competitiveness and may lead to claims from the Federal Tax Service.
How to avoid violations and minimize risks
To prevent possible negative consequences, be sure to:
- Check your suppliers. Request valid registration certificates for every item from suppliers or manufacturers and verify their authenticity in the Roszdravnadzor register.
- Monitor changes in legislation. Pay particular attention to labeling requirements and lists that are updated regularly.
- Don't neglect professional support. When bringing new medical devices to market, consult regulatory experts to complete the registration procedure correctly.
The process of legalizing medical devices
The only legal way to bring a medical device to market is to pass state registration with Roszdravnadzor.
Stages of obtaining a registration certificate:
Stages of obtaining a registration certificate:
- Classification and strategy. Determining the risk class (1–3) and planning the required studies.
- Testing. Carrying out technical, toxicological and clinical tests in accredited laboratories.
- Dossier preparation. Compiling a complete set of documents, including technical documentation, test reports and labeling samples.
- Application and expert review. Submitting the documents to Roszdravnadzor and undergoing the expert review of quality, efficacy and safety.
- Issuance of the certificate. If the expert review is positive, the medical device is entered into the state register and the registration certificate is issued to the applicant.