For Class 2A medical device registration with Roszdravnadzor (RZN) in Russia, the technical documentation requirements are essential to demonstrate the safety, efficacy, and compliance of the device with Russian regulations. Below is a list of the key technical documents that must be provided as part of the registration application.

Key Technical Documentation Requirements for Class 2A Medical Device Registration in Russia

1. Registration Application Form

• This is the official form to be completed and submitted to Roszdravnadzor. It includes basic information about the manufacturer, the device, and its intended use.
  • This form can be submitted online via the Roszdravnadzor portal or in paper form.

2. Manufacturer's Legal Documents

• Certificate of Incorporation: Proof that the manufacturer is a legally established entity.
• Power of Attorney (POA): If the manufacturer is based outside of Russia, a local representative (Russian legal entity) must submit the application on the manufacturer's behalf. The manufacturer must provide a POA to the local representative.
• Certificate of Free Sale (CFS): This certificate indicates that the device is freely marketed and sold in the country of origin or another major market (e.g., the EU, US).
  • CFS must be issued by the regulatory authority in the country of manufacture and should be notarized and translated into Russian.

3. Device Description and Intended Use

• A detailed description of the medical device, including:
  • Name and model of the device.
  • Intended use: Description of the device's purpose, indications, and how it is used in practice.
  • Principle of operation: Explanation of how the device works and its technology.
  • Risk classification: Confirmation that the device is classified as Class 2A in accordance with Russian regulations.

4. Quality Management System (QMS) Documentation

• The manufacturer must demonstrate compliance with a Quality Management System (QMS), usually based on ISO 13485.
  • ISO 13485 Certificate: If the manufacturer has an ISO 13485 certification, this should be provided as part of the application. If the manufacturer is based outside of Russia, the QMS certificate must be issued by an accredited body.

5. Risk Management File (Risk Analysis)

• A Risk Management Report prepared according to the international standard ISO 14971 (Risk management for medical devices).
  • This document should assess the potential risks associated with the device, outline how those risks will be mitigated, and demonstrate how the device is designed and tested to ensure safety.

6. Clinical Data or Performance Data

• Clinical Evaluation Report (CER):
  • If applicable, especially for devices that involve new technology or direct interaction with the human body, provide clinical data or a clinical evaluation report that supports the device’s safety and efficacy.
  • Clinical trials may be required if no prior clinical data exists.
  • If the device is already approved in another market (e.g., EU, US), clinical data from those markets can often be used to support the registration in Russia.

7. Product Samples

• Product samples may be required by Roszdravnadzor to verify compliance, especially if the device has not been registered in other markets.
  • These may be subjected to testing or evaluation by Russian authorities, although this is less common for low-risk Class 2A devices.

8. Safety and Performance Testing Reports

• Safety Testing: Demonstrate that the device has been tested for biocompatibility (e.g., according to ISO 10993 for materials in contact with the body) and other safety standards.
  • Electrical Safety and EMC (Electromagnetic Compatibility): If the device is electrical, evidence of electrical safety and EMC compliance (e.g., IEC 60601-1 and IEC 60601-1-2 standards) may be required.

9. Labeling and Instructions for Use (IFU)

• Russian Language Labeling: All labeling materials, including the device’s label, instructions for use (IFU), and packaging, must be in Russian and comply with Russian regulatory requirements.
  • The labeling should include mandatory information such as the manufacturer’s name and address, country of origin, instructions for safe use, warnings, contraindications, and storage conditions.
  • Ensure that the symbol system used on the packaging and labeling complies with Russian regulations.

10. Declaration of Conformity

• A Declaration of Conformity issued by the manufacturer, confirming that the device complies with Russian technical regulations and international standards.
  • If the device has been CE-marked in the EU, the CE Declaration of Conformity can serve as the basis for the Russian Declaration of Conformity.

11. Software Documentation (if applicable)

• If the device includes software, you may need to provide documentation on the software used in the device. This includes:
  • Software Design Description: Overview of the software architecture and functionality.
  • Software Validation: Evidence that the software has been tested and validated according to regulatory requirements (e.g., IEC 62304 for medical device software).

12. Post-Market Surveillance Plan

• A plan outlining how the manufacturer will manage post-market surveillance (PMS) in Russia, including how adverse events or device malfunctions will be reported to Roszdravnadzor.
  • For Class 2A devices, post-market surveillance requirements are typically less stringent than for higher-risk devices, but manufacturers must still have a system in place for tracking and reporting any issues.

Additional Considerations

• Translation Requirements: All documents must be submitted in Russian. You will need to work with a professional translation service to ensure that all documentation is accurately translated.
• Regulatory Expert: If you are unfamiliar with Russian regulatory processes, it may be beneficial to work with a regulatory affairs expert or local representative to guide you through the submission process and ensure all technical documentation is in order.

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