Cost and Time Required for 3rd Class Medical Device RZN Registration in Russia

Registering a 3rd class medical device (high-risk device) with Roszdravnadzor (RZN) in Russia involves significant time and financial investment. The process is detailed, involving various stages such as documentation preparation, clinical trials (if applicable), laboratory testing, and expert reviews. Below is an overview of the typical costs and timeframe for handling a Class 3 medical device RZN registration in Russia:

1. Time Required for 3rd Class Medical Device RZN Registration

The registration process for a Class 3 medical device can take between 6 months to 1 year or more, depending on several factors:

a. General Timeline Overview

• Pre-Registration Phase: This involves gathering all the necessary documentation, including technical files, clinical data, risk assessments, and quality management certifications. This stage can take 1-3 months depending on the complexity of the device and the availability of required data.
• Application Submission and Evaluation: Once the documents are submitted, Roszdravnadzor will review the application. This phase usually takes 4-6 months.
• Clinical Trials (if required): If clinical trials are needed, the process can take anywhere from 6 months to 1 year, depending on the trial’s complexity and whether the trials are conducted in Russia or another jurisdiction.
• Laboratory Testing (if applicable): If testing for biocompatibility, sterility, electrical safety, or other parameters is required, it could take an additional 1-3 months.
• Approval and Issuance: After Roszdravnadzor evaluates all documentation and test results, it typically takes about 1-2 months to issue the final registration certificate.

b. Total Timeframe

The overall timeline for 3rd class medical device registration is typically 6 months to 12 months. However, it can extend beyond 12 months if there are additional requirements like clinical trials, inspections, or delays in documentation review.

2. Cost for 3rd Class Medical Device RZN Registration

The costs involved in registering a Class 3 medical device in Russia can vary depending on the complexity of the device, the need for clinical trials, and the extent of testing required. Below is a breakdown of potential costs:

a. Regulatory Fees to Roszdravnadzor

• The registration fee for a 3rd class medical device is typically higher than for Class 1 or Class 2 devices due to the comprehensive review process.
• The cost for submitting an application can range from $2,000 to $5,000 USD or more, depending on the device and the nature of the submission (e.g., whether there are additional requests for testing or trials).
• Additional fees may apply if Roszdravnadzor requires an on-site inspection of the manufacturing facility.

b. Costs for Clinical Trials (if required)

• Clinical trials can be a significant cost factor, especially for Class 3 devices, as they often require more extensive testing to demonstrate safety and efficacy.
• The cost of clinical trials can range from $50,000 to $200,000 USD or more, depending on the device, the number of trials, the duration, and the clinical sites involved.

c. Laboratory Testing Fees

• Testing fees for medical devices vary depending on the type of tests required (e.g., biocompatibility, electrical safety, etc.).
• Testing for a Class 3 device can cost between $5,000 and $30,000 USD depending on the number and type of tests.

d. Authorized Representative Fees

• Foreign manufacturers must appoint a local authorized representative in Russia, which typically involves a fee for their services.
• The authorized representative charges can vary, but generally range from $10,000 to $30,000 USD annually, depending on the scope of services and the complexity of the device.
• This fee includes services such as submitting documentation, liaising with Roszdravnadzor, ensuring compliance with local laws, and managing post-market obligations.

e. Other Costs

• Translation Costs: All documents must be submitted in Russian or translated into Russian. Translation costs can add an additional $2,000 to $5,000 USD, depending on the volume of documents.
• GOST-R Certification: If required, obtaining GOST-R certification (compliance with Russian technical standards) may cost an additional $2,000 to $10,000 USD.

Summary of Costs

• Registration Fees to Roszdravnadzor: $2,000 - $5,000 USD
• Clinical Trials (if applicable): $50,000 - $200,000 USD
• Laboratory Testing: $5,000 - $30,000 USD
• Authorized Representative Fees: $10,000 - $30,000 USD per year
• Translation and Certification Fees: $2,000 - $5,000 USD

Estimated Total Cost: For a Class 3 medical device, the overall cost can range from $70,000 to $300,000 USD or more, depending on the device’s complexity and the requirements set by Roszdravnadzor.

Key Considerations

1. Device Complexity: Devices that require extensive clinical trials, laboratory testing, or compliance with additional standards will incur higher costs.
2. Timely Submission: Delays in documentation or clinical trials may extend the time and increase the cost.
3. Local Representation: Hiring an experienced local authorized representative or regulatory consultant can help streamline the process but adds to the cost.
4. Post-Market Requirements: Ongoing post-market surveillance, reporting of adverse events, and registration renewal will also require continued investment.

By planning ahead and working with professionals who are familiar with the Russian regulatory landscape, you can minimize delays and unexpected costs in the registration process.

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