Ensure your medical device is correctly classified as Class 3 according to Russian regulations. Class 3 devices are those that carry the highest risk, such as implantable devices or devices used to monitor vital functions.

The time required to obtain Class 2A medical device registration in Russia with Roszdravnadzor (RZN) generally ranges between 6 to 12 months. This timeline depends on various factors, including the completeness of the application, the need for additional testing, and RZN's review process.

No, an annual review is not required for Class 2A medical device registration in Russia with Roszdravnadzor (RZN). Once the Registration Certificate is issued, it is typically valid indefinitely unless specific circumstances arise that necessitate a review or update.

Obtaining 2A class medical device registration in Russia with Roszdravnadzor (RZN) offers several significant benefits for manufacturers and distributors aiming to access the Russian market.

The registration period for a Class 2A medical device in Russia with Roszdravnadzor (RZN) can vary depending on the complexity of the device, the completeness of the application, and whether additional testing or local clinical trials are required. On average, the process takes 6 to 12 months.

Class 2A refers to a category of medical devices with medium risk to patients and users.

Confirm that the device falls under Class 2A according to the Russian TR CU 019/2011 technical regulation for medical devices. This classification determines the requirements for testing and documentation.

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.