Drugdu.com expert's response:

The registration process for Class III medical devices in Russia typically requires a period of 24 months or more. Based on official requirements and information from reference articles, here is a detailed explanation and summary of the registration timeline:

Medical Device Classification: According to the Russian medical device classification standards, Class III medical devices fall into the high-risk category, requiring a more stringent registration and review process.

Registration Process: The registration process includes appointing a Russian authorized representative, product classification identification, submitting technical documentation for medical devices, conducting system audits (if applicable), and undergoing RZN evaluation.

Registration Timeline:

Initial Review: Once the application materials are complete, the registration agency will submit the application to the Russian Federal Service for Surveillance in Healthcare (Roszdravnadzor). The initial review may take several weeks to several months to confirm the completeness and compliance of the application documents.

Detailed Review and Evaluation: Roszdravnadzor will conduct a detailed review and evaluation of the application to ensure that the medical device complies with Russian regulations and standards. This stage may require several months, depending on the complexity of the application and the efficiency of the approval agency.

Clinical Trials (if applicable): If clinical trials are required for the medical device, the completion of these trials may require additional time, typically several months or longer.

Issuance of Registration Certificate: Once the application is approved, Roszdravnadzor will issue a medical device registration certificate. This process may take several weeks to several months, depending on the work procedures and scheduling of the approval agency.

In summary, considering all the steps and stages mentioned above, the registration process for Class III medical devices in Russia typically requires 24 months or more. However, it is important to note that the actual processing time may vary depending on individual cases, such as the type of device, complexity, and the time required to prepare the necessary documents.

Therefore, before initiating the application process, it is recommended to contact a registration agency or relevant approval department to understand the specific processing timeline and procedures.