The registration process for Class I medical devices with Roszdravnadzor (RZN), Russia’s regulatory authority for healthcare products, is relatively straightforward due to the low-risk classification of these devices. However, compliance with Russian medical device regulations is still mandatory, and certain documents and considerations are needed.

Here is a detailed overview of the registration process and required documents for Class I medical devices in Russia:

Registration Process for Class I Medical Devices with Roszdravnadzor

Step 1: Prepare Documentation

To begin the registration process, the manufacturer or the authorized representative in Russia must collect and prepare the required documentation. These documents provide essential information about the device’s safety, quality, and intended use.

Step 2: Create an Account on Roszdravnadzor Portal (if applying online)

• Online Submission: The preferred method for submitting your registration application is through the Roszdravnadzor online portal (https://www.rospotrebnadzor.ru).
  • Create an account and register on the portal.
  • Fill in the registration application form for a Class I medical device.

Step 3: Submit the Application

• After completing the application form, you will need to upload the required documents (listed below).
• If your company is located outside Russia, you will need to appoint an authorized representative in Russia to handle the submission process on your behalf.

Step 4: Pay the Registration Fee

• The application will require payment of a registration fee. The amount for Class I medical devices is generally low compared to higher-risk classes. Payment can be done via the portal or by other approved methods.

Step 5: Document Review by Roszdravnadzor

• Roszdravnadzor will conduct a review of the submitted documents to ensure they comply with Russian medical device regulations.
• The review process generally takes around 2 to 3 months for Class I devices.

Step 6: Issuance of Registration Certificate

• If all documents are in order and meet regulatory requirements, Roszdravnadzor will issue a registration certificate. This certificate allows the device to be marketed and sold in Russia.
• The registration certificate is typically valid for 5 years, after which renewal is required.

Step 7: Post-Registration Obligations

• Post-market surveillance: Once the device is registered, manufacturers must report any adverse events, safety issues, or recalls to Roszdravnadzor.
• If there are significant changes to the device (such as design, manufacturing process, labeling), the device may need to be re-registered.

Required Documents for Class I Medical Device Registration

1. Registration Application Form:

   • A completed application form available on the Roszdravnadzor portal.

2. Certificate of Free Sale (CFS):

   • A Certificate of Free Sale from the country of origin, proving that the device is legally sold in the country of manufacture.
   • The CFS should be translated into Russian and must be current (issued within the last 6 months).

3. Product Description:

   • A detailed description of the device, including its intended use, technical specifications, and how it works.
   • This document should clearly define the Class I classification of the device.

4. Manufacturing Information:

   • Information about the manufacturer, including:
     • Manufacturer’s name and address.
     • Details about the quality management system (e.g., ISO 13485 certification).
     • Proof that the manufacturing process meets international standards for quality and safety.

5. Instructions for Use (IFU):

   • A user manual in Russian, outlining how the device is to be used, maintained, and disposed of.
   • The IFU must meet specific Russian requirements and include details such as warnings, contraindications, and proper usage.

6. Labeling Information:

   • Labels and packaging must be compliant with Russian regulations, and all information must be in Russian.
   • Labels should include the device name, manufacturer details, expiration date, storage conditions, and other relevant details.

7. Risk Management Document:

   • A risk management file that evaluates the potential risks associated with the device.
   • For Class I devices, this is usually simpler, but it must still demonstrate that the device does not pose significant risks to patient safety.

8. Clinical or Performance Data:

   • Clinical or performance data are generally not required for Class I devices, but they might be necessary in certain cases if the device poses special risks.
   • For most Class I devices, documentation regarding design, safety testing, and performance should suffice.

9. Authorized Representative Agreement (if applicable):

   • If the manufacturer is based outside Russia, an authorized representative in Russia must be appointed to handle the registration process. An agreement or contract between the manufacturer and the representative must be submitted.

Key Considerations for Class I Medical Device Registration

1. Language Requirements:

   • All documents submitted to Roszdravnadzor must be in Russian. This includes product descriptions, instructions for use, certificates, and labeling information.
   • If documents are originally in another language (e.g., English), they must be professionally translated into Russian.

2. Authorized Representative:

   • If the manufacturer is located outside Russia, the appointment of an authorized representative in Russia is mandatory. This representative will handle all communication with Roszdravnadzor and will be responsible for submitting the application, tracking the progress, and receiving the registration certificate.

3. Compliance with Russian Standards:

   • The device must meet the Russian medical device regulations and comply with Eurasian Economic Union (EAEU) regulations, which apply to Russia, Kazakhstan, Belarus, Armenia, and Kyrgyzstan.
   • Ensure that the device follows the required GOST (Russian National Standards) and technical regulations.

4. Post-Market Surveillance:

   • After registration, the manufacturer must be aware of post-market obligations, including the reporting of adverse events, device recalls, and any changes made to the device.
   • Regular updates or modifications to the device might necessitate re-registration or amendments to the original registration.

Conclusion

Registering a Class I medical device with Roszdravnadzor (RZN) in Russia involves submitting detailed documentation, completing the registration application form, and ensuring compliance with Russian regulations. The process typically takes 2 to 3 months, and the registration certificate is valid for 5 years. If the manufacturer is located outside Russia, they must appoint an authorized representative in Russia to handle the registration on their behalf.

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