Medical Devices

Sales rules

Upload documents confirming quality: a valid certificate for medical devices registered:

• in Russia: for sale of medical devices only in the Russian Federation;

• in the EAEU: for sale of medical devices in the Russian Federation and other countries. The registration certificate shall include the country in which you will sell the product.

If the registration application is submitted after March 1, 2025:

• For sales in EAEU countries: provide the unique number of the registry entry and the date of state registration of the medical device.
• For sales in Russia: upload an extract from the Roszdravnadzor registry instead of the registration certificate.

Medical devices

• Any instruments, apparatuses, devices, equipment, materials, and other products used for medical purposes:
  • prevention;
  • diagnostics;
  • treatment and medical rehabilitation;
  • monitoring of the human body condition;
  • conducting medical research;
  • recovery;
  • replacement;
  • anatomical and physiological changes;
  • prevention or termination of pregnancy.
• Necessary accessories for the intended use of such products. For example, specialized software.

The use of such products shouldn’t affect the human body pharmacologically, immunologically, genetically, or metabolically.

Take into account which products we consider to be medical devices, including but not limited to, and in which categories they should be placed:

Categories of medical devices (XLSX)

For sales in Russia

Download registry extracts

1. On the Roszdravnadzor website, enter the registration number of the medical device in the search bar and click the magnifying glass icon.
2. In the search results, you can:
   • Scroll to the right and download the extract.
   • Open the register entry and view the extract. To check registration certificates issued before March 1, 2025, you can use the Roszdravnadzor archive.

Find model number of medical device

On the Roszdravnadzor website, find your registration certificate using the search bar and open it.

You can see its number in the table with model numbers, in the “Уникальный номер модели” (“Unique model number”) column.

Checks when uploading registration certificate

1. Make sure the document is correct. Registration certificates are issued only by Roszdravnadzor. We don’t accept:
   • certificates and declarations of conformity;
   • certificates of state registration;
   • contracts, trademarks, and other documents.
2. Create a separate document for each registration certificate. One document should contain only one number. If you upload several certificates in one document, we can’t verify them in the registry.
3. Check the number and validity dates.

Don’t add extra symbols such as №, dashes, commas, or others. The number must exactly match the format in the registration certificate.

Start selling products

1. Upload products.

   Learn more about uploading products

   Fill out the Model number of a medical device сharacteristic. If there is no number, specify “Not provided”.

2. In the Products and prices → Quality сertificates section, upload the registration certificate.

3. In the Add certificate window, specify the products for which the document is suitable. You can add them manually or upload them in an XLSX file. In the second case, specify the product article codes as in your account.

4. Make sure that:

   • You’ve uploaded quality documents.
     Learn more about uploading documents
   • You’ve filled out product characteristics.
   • The product images meet the requirements.

After successful moderation, you can sell products on Ozon.

Learn more about product moderation