The time required for 2A class medical device registration in Russia with Roszdravnadzor (RZN) depends on various factors, such as the complexity of the device, the completeness of the submitted documentation, and whether additional testing or local clinical trials are needed. Typically, the process takes 6 to 12 months. Below is an outline of the timeframes and the steps involved in the review process:

Steps Involved in the Review Process

1. Pre-Submission Preparation

Before submitting the application:

• Device Classification: Confirm the classification of your device as Class 2A.
• Documentation Preparation: Gather and translate all required documents (technical files, test reports, clinical data, etc.).
• Testing: Conduct any necessary preclinical, technical, or safety tests.

Timeframe: 1–3 months, depending on document readiness and testing needs.

2. Submission Review

• Submit your application to RZN online and in hard copy.
• RZN validates the submission to ensure all required documents are included.
• If the documentation is incomplete or unclear, RZN may issue a request for clarification or additional materials.

Timeframe: 1 month for validation.

3. Laboratory Testing

• If required, RZN conducts additional tests in accredited laboratories to confirm compliance with safety and performance standards.
• Testing includes:
  • Biological and electrical safety.
  • Mechanical and functional testing (if applicable).

Timeframe: 2–3 months, depending on the scope of testing required.

4. Clinical Data Review

• RZN evaluates the clinical evidence provided in the application.
• If the submitted data does not meet Russian standards, you may need to conduct local clinical trials.
• Local trials typically take longer (3–6 months) and require pre-approval from RZN and local ethics committees.

Timeframe: 3–6 months (or longer if local trials are needed).

5. Expert Panel Evaluation

• A panel of RZN experts assesses the device's safety, efficacy, and compliance with regulatory standards based on submitted and tested data.
• The panel may request clarifications or additional testing if concerns arise.

Timeframe: 1–2 months.

6. Final Decision and Certificate Issuance

• If the device meets all requirements, RZN issues a Registration Certificate.
• If deficiencies remain, the application may be rejected, or RZN may request further modifications and resubmission.

Timeframe: 1 month.

Factors That May Extend the Timeline

1. Incomplete Documentation: Missing or insufficient documentation will result in delays while additional information is provided.
2. Local Clinical Trials: Mandatory for devices without sufficient international clinical data or compliance with Russian standards.
3. Additional Testing: If discrepancies are found during the review, RZN may require supplementary testing.
4. Backlog at RZN: Processing delays can occur due to high application volumes or administrative issues.

Summary of Steps

1. Pre-Submission Preparation (1–3 months): Gather documentation and conduct initial testing.
2. Submission and Validation (1 month): Submit application and address RZN’s preliminary review.
3. Laboratory Testing (2–3 months): Perform required tests in accredited labs.
4. Clinical Data Review (3–6 months): Submit or conduct clinical trials, if necessary.
5. Expert Evaluation (1–2 months): Undergo detailed review by RZN’s expert panel.
6. Certificate Issuance (1 month): Receive the final registration certificate.

By following these steps and accounting for potential delays, the **2A class medical device registration process

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