中文|English
中文|English
What are the requirements for obtaining RZN certification for Class I medical devices?
Release time：2024-08-20 11:03:48 The author: source:
Technical Documentation: Include detailed product specifications, technical descriptions, and labeling information.

To obtain RZN certification for Class I medical devices, you'll need to meet the following requirements:

  1. Technical Documentation: Include detailed product specifications, technical descriptions, and labeling information.
  2. Quality Management System: Demonstrate compliance with relevant quality management standards, often including ISO 13485.
  3. Compliance with Standards: Provide evidence that the device meets Russian safety and performance standards.
  4. Application Form: Complete and submit the official application form to Roszdravnadzor.
  5. Product Testing: If required, submit your device for testing to verify conformity with Russian regulations.

Ensure all documents are in Russian or properly translated. Do you need more information on any of these requirements?

national-cancer-institute-klUaFqLAcFw-unsplash.jpg

Contact Us：

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


Last one: What are the costs and time required for RZN certification of Class I medical devices?
The next one: What are the processes and steps for RZN certification of Class I medical devices?
return