Confirm that your device is classified as Class 2A under Russian regulations. Use the guidelines in TR CU 019/2011 (EAEU technical regulation for medical devices) to determine the classification.

For maintaining compliance after registering a Class 2A medical device in Russia with Roszdravnadzor (RZN), periodic updates and adherence to established procedures are critical. These updates ensure the device remains aligned with regulatory requirements and can be legally marketed and used in Russia.

After applying for Class 2A medical device registration in Russia with Roszdravnadzor (RZN), you must adhere to specific regulations and requirements to maintain compliance during and after the registration process. These regulations cover quality, documentation, communication, and post-market obligations.

Before applying for Class 2A medical device registration in Russia with Roszdravnadzor (RZN), thorough preparation is essential to ensure a smooth application process and compliance with all regulatory requirements.

After obtaining approval for Class 2A medical device registration with Roszdravnadzor (RZN) in Russia, there are several important steps and considerations to keep in mind to ensure compliance with regulatory requirements and to effectively manage your product in the Russian market.

For Class 2A medical device registration in Russia with Roszdravnadzor (RZN), the device must comply with a variety of standards and regulations to ensure its safety, efficacy, and quality. These standards encompass Russian, European, and international requirements, as well as specific guidelines provided by Roszdravnadzor for medical devices.

For Class 2A medical device registration with Roszdravnadzor (RZN) in Russia, the technical documentation requirements are essential to demonstrate the safety, efficacy, and compliance of the device with Russian regulations. Below is a list of the key technical documents that must be provided as part of the registration application.

The processing time for Class 2A medical device registration with Roszdravnadzor (RZN) in Russia typically ranges from 6 to 12 months, but this can vary depending on several factors such as the complexity of the device, completeness of the application, and the specific requirements of Roszdravnadzor at the time.