Before applying for Class 2A medical device registration in Russia with Roszdravnadzor (RZN), thorough preparation is essential to ensure a smooth application process and compliance with all regulatory requirements. Below are the key preparations you need to make:

1. Classification Verification

• Confirm the Classification: Ensure your device is classified as Class 2A under Russian regulations. Class 2A devices typically include those with moderate risk that come into contact with the human body for a limited period. If uncertain, consult Roszdravnadzor or a regulatory expert.
• Consult Guidance Documents: Refer to applicable Russian classification rules and verify alignment with TR CU 019/2011 (EAEU Technical Regulation on the Safety of Medical Devices).

2. Regulatory and Legal Readiness

• Appoint an Authorized Representative (AR):
  If you are a foreign manufacturer, you must appoint a local Authorized Representative (a Russian legal entity) to act as your liaison with Roszdravnadzor.

• Understand Legal Requirements:
  Familiarize yourself with the Federal Law No. 323-FZ, relevant Decrees, and the EAEU Technical Regulation TR CU 019/2011, which govern medical device registration in Russia.

• Establish a Contract:
  Sign a contract with your local AR detailing their responsibilities, including document submission, communication with RZN, and post-market surveillance.

3. Technical File Preparation

Prepare a comprehensive technical file containing the following documents:

• Device Description:

  • Detailed description of the device and its intended use.
  • Technical specifications and operating principles.
  • Photos, diagrams, and technical drawings.

• Risk Analysis:

  • Risk management file in compliance with ISO 14971.
  • Identification and mitigation of risks associated with the device.

• Design and Manufacturing Documents:

  • Design validation and verification reports.
  • Manufacturing process description, including details on raw materials, components, and final assembly.

• Clinical Evaluation Report:

  • Clinical data proving the device’s safety and efficacy, as per ISO 14155 or equivalent standards.

• Quality Management System (QMS) Certification:

  • A valid ISO 13485 certificate or equivalent to demonstrate adherence to QMS requirements.

• Biocompatibility and Safety Reports:

  • Testing data in accordance with ISO 10993 for biocompatibility.
  • Sterilization validation (if applicable).

• Electromagnetic Compatibility (EMC) Testing:

  • For devices with electrical components, ensure compliance with IEC 60601-1-2 (EMC requirements).

4. Product Testing and Certification

• Preclinical Laboratory Testing:
  Conduct tests to demonstrate compliance with safety and performance requirements. Testing must be conducted in accredited Russian laboratories or recognized international facilities.

• Sterilization Validation:
  If your device requires sterilization, ensure it meets Russian standards (e.g., GOST R 51617-2000) for sterilization validation.

• Toxicology Testing:
  Submit toxicology test reports for materials that come into contact with the body.

• Labeling and Packaging Testing:
  Verify that your device’s labeling and packaging meet the requirements of GOST R 51524-2004.

5. Labeling and Instructions for Use (IFU)

• Russian Language Compliance:
  All labeling, packaging, and Instructions for Use (IFU) must be translated into Russian.

• Label Content:

  • Device name and model.
  • Manufacturer’s name and address.
  • Importer’s name and address (if applicable).
  • Expiry date and sterilization method (if applicable).
  • Usage and storage conditions.

• IFU Content:

  • Indications, contraindications, and warnings.
  • Instructions for use, maintenance, and disposal.
  • Detailed illustrations if needed for proper use.

6. Clinical Evidence

• Compile Clinical Data:
  Gather clinical evidence from previous studies, trials, or market data (if the device is CE-marked or already in use elsewhere).

• Conduct Local Clinical Trials (if necessary):
  For devices not previously marketed or lacking sufficient clinical data, you may need to conduct clinical trials in Russia according to ISO 14155.

7. Document Translations

Translate all documents into Russian, including:

• Technical file.
• Clinical evaluation report.
• Risk management documents.
• Test reports and certifications.
• Instructions for Use (IFU) and labeling.

8. Fees and Timeline Preparation

• Registration Fees:
  Prepare to pay the registration fees associated with testing, document submission, and Roszdravnadzor's review.

• Anticipate Timeline:
  Registration for Class 2A devices typically takes 6–12 months. Plan accordingly for testing, documentation preparation, and RZN review processes.

9. Pre-Application Consultation

• Engage with RZN or Experts:
  Consider consulting with Roszdravnadzor or a regulatory expert to clarify requirements specific to your device and address any uncertainties.

• Local Testing Lab Coordination:
  Establish agreements with local testing labs accredited by RZN to conduct required tests.

10. Post-Market Surveillance (PMS) Plan

Prepare a Post-Market Surveillance (PMS) Plan outlining:

• Methods for monitoring device performance and safety after market entry.
• Processes for reporting adverse events and implementing corrective actions.