The duration of the Class I medical device registration process with Roszdravnadzor (RZN) in Russia typically takes between 2 to 3 months, assuming that all required documentation is complete and in compliance with the regulatory requirements. The timeline can vary depending on the specifics of the application and any potential issues or requests for additional information from RZN.

Here’s an overview of the timeline:

Typical Steps and Time Estimates:

1. Preparation of Documentation (1-2 weeks):

   • Collecting and preparing the required documents, such as technical specifications, safety reports, quality certificates, and labeling, can take some time depending on the availability of the materials.

2. Submission to RZN:

   • Once all documents are ready, the application can be submitted to Roszdravnadzor either through their online portal or via direct submission.

3. RZN Review (4-6 weeks):

   • Roszdravnadzor will review the application and all submitted documentation. This process generally takes 4 to 6 weeks. During this time, they will verify that the device meets all technical, safety, and regulatory standards.

4. Issuance of Registration Certificate (1-2 weeks after approval):

   • After successful review and approval, the registration certificate is issued, which allows the device to be legally marketed in Russia. This typically takes an additional 1 to 2 weeks after the review process.

Factors That May Affect Duration:

• Completeness of the Application: If any information is missing or incorrect, RZN may request additional documentation, which can delay the process.
• Changes to the Device: If the device undergoes any changes during the process (e.g., in design, intended use, or manufacturer), this may require further evaluation and extend the timeline.
• Workload at RZN: Depending on the volume of applications RZN is handling, the timeline might vary, though Class I registrations generally experience a shorter review period than higher-risk devices.

Summary:

The entire process of registering a Class I medical device with Roszdravnadzor typically takes around 2 to 3 months. However, if there are complications or requests for additional information, this timeline could be extended.