The costs and time required for obtaining RZN certification for Class 2a medical devices in Russia can vary based on several factors. Here’s a general overview:

Costs

1. Application Fees:

   • Typically range from $2,000 to $5,000 USD. This includes the administrative costs of processing the application.

2. Testing Fees:

   • Costs for device testing can vary widely depending on the complexity of the device and the type of tests required. This can range from $2,000 to $10,000 USD.

3. Consultancy Fees:

   • If you hire a local regulatory consultant to assist with the application process, fees can range from $1,000 to $5,000 USD, depending on the level of service.

4. Additional Costs:

   • Translation of documents into Russian, legalization, and notarization may add additional costs.

Time Required

1. Preparation:

   • Gathering and preparing documentation can take several weeks to a few months, depending on the completeness of your existing documentation and any additional information needed.

2. Review and Testing:

   • The review and testing process typically takes 2 to 6 months. This includes the time required for the Certification Body to assess the documentation and conduct any necessary tests.

3. Certification Issuance:

   • Once the review and testing are complete, certification can take an additional 1 to 2 months, depending on the efficiency of the Certification Body.

Total Time Estimate

• Overall Time: Generally, the entire process from application submission to obtaining certification can take approximately 6 to 12 months.

Note: These are general estimates and can vary based on the specifics of your device, the workload of the Certification Body, and other factors. Working with a local consultant can help streamline the process and provide more accurate cost and time estimates based on your specific situation.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn