To apply for Class 2A medical device registration in Russia with Roszdravnadzor (RZN), certain conditions and requirements must be met to ensure the device complies with Russian medical device regulations. Class 2A medical devices are considered low- to moderate-risk devices, and the regulatory process for them is less complex than for higher-risk classes (like Class 3 or Class 2B devices), but there are still several important conditions to fulfill.

Here are the main conditions that must be met to apply for Class 2A medical device registration in Russia:

1. Compliance with Russian Medical Device Classification

• The device must be classified as Class 2A according to Russian regulations. The classification is based on the risk level of the device and its intended use.
  • Class 2A devices are typically low-risk devices, such as certain diagnostic devices, medical equipment, and other products that do not pose significant risks to patients or users when used as intended.
  • Devices falling under Class 2A are considered moderate risk compared to higher-risk devices (such as implants or life-supporting equipment).

Action: Verify that your device falls under the Class 2A classification using Russian regulations or a recognized international classification (such as the EU MDR or FDA classification).

2. Appointment of a Local Representative (for Foreign Manufacturers)

• Foreign manufacturers must appoint a local representative in Russia. This representative, typically a Russian legal entity (distributor or regulatory affairs consultant), will handle the registration process on behalf of the foreign manufacturer.
  • The local representative will submit the registration application and manage communications with Roszdravnadzor.

Action: If you are a foreign manufacturer, appoint a local representative in Russia and provide them with a Power of Attorney (POA) to act on your behalf.

3. Compliance with Russian Standards and Regulations

• The device must comply with the relevant Russian technical standards and regulations, which are aligned with international standards (e.g., ISO 13485, ISO 14971 for risk management, ISO 10993 for biocompatibility).
• The device must be safe and effective for its intended use, which is supported by sufficient technical documentation (such as performance data, risk analysis, and clinical evaluation if applicable).

Action: Ensure that your device meets Russian safety and performance requirements. Prepare the necessary technical documentation (e.g., risk management files, clinical evaluation reports, biocompatibility testing).

4. Quality Management System (QMS) Certification

• The manufacturer must provide evidence of a Quality Management System (QMS) in place that meets ISO 13485 standards. This certification shows that the manufacturer follows consistent procedures for the design, production, and post-market surveillance of medical devices.
• If the manufacturer is foreign, they must provide an ISO 13485 certificate issued by an accredited certifying body.

Action: Ensure your company holds a valid ISO 13485 certification or equivalent for the manufacturing of medical devices. This will be necessary to demonstrate quality control compliance.

5. Compliance with Clinical and Performance Requirements

• Depending on the nature of the Class 2A device, the manufacturer may need to provide evidence of clinical performance or clinical safety, especially for devices that directly interact with patients or have new or innovative technology.
  • For devices already marketed in another country (e.g., EU, US), clinical data or performance data from those markets can often be used to support the application in Russia.
  • Clinical trials or clinical evaluation reports might be required if no prior data exists.

Action: Provide clinical data or performance testing documentation if required, especially for new devices. If the device is already approved in another market (e.g., CE-marked), clinical data from those markets can help facilitate the registration process.

6. Local Language Requirements

• All documentation submitted to Roszdravnadzor must be in Russian. This includes technical documentation, labels, instructions for use, and any supporting regulatory documents.
• For foreign manufacturers, all necessary documents must be translated into Russian by a professional translator, and labels and instructions for use should comply with Russian language requirements.

Action: Ensure that all documents are translated into Russian by a qualified translator and are consistent with Russian regulatory labeling requirements.

7. Compliance with Post-Market Surveillance and Adverse Event Reporting

• Once the device is registered, the manufacturer must comply with Russian post-market surveillance and adverse event reporting requirements.
  • This includes keeping track of any potential safety issues or malfunctions and reporting them to Roszdravnadzor as required by Russian law.
  • Manufacturers are also required to provide post-market clinical follow-up (PMCF) data where applicable.

Action: Be prepared for ongoing post-market surveillance and adverse event reporting in Russia.

8. Manufacturer's History and Reputation

• Roszdravnadzor will assess the reputation and history of the manufacturer. If the manufacturer has been involved in past regulatory issues or recalls, this may affect the likelihood of approval.
  • Compliance history in other markets (such as the EU or U.S. FDA) may be considered in the evaluation process.

Action: Ensure that your company has a clean regulatory record, and be prepared to provide references from other regulatory authorities if needed.

9. Payment of Registration Fee

• There is a registration fee associated with submitting an application for medical device registration in Russia. The fee is usually in the range of RUB 100,000 to RUB 300,000 (approximately USD 1,000 to USD 3,000).
• The fee must be paid at the time of application, either through the Roszdravnadzor portal (for online submissions) or through a payment method provided if submitting by mail.

Action: Be prepared to pay the required registration fee during the application process.

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