中文|English
中文|English
What are the standards for RZN certification of Class I medical devices?
Release time：2024-08-20 11:09:08 The author: source:
Russian Technical Regulations: Ensure compliance with relevant Russian technical regulations governing medical devices. For example, Technical Regulation TR TS 020/2011 covers safety requirements for medical devices.

For RZN certification of Class I medical devices, the key standards include:

  1. Russian Technical Regulations: Ensure compliance with relevant Russian technical regulations governing medical devices. For example, Technical Regulation TR TS 020/2011 covers safety requirements for medical devices.

  2. ISO 13485: Demonstrate adherence to the international standard for quality management systems in medical device manufacturing.

  3. ISO 14971: Provide evidence of risk management practices according to the international standard for risk management in medical devices.

  4. GOST Standards: Compliance with applicable GOST standards, which are Russian national standards, may be required for specific device types.

  5. IEC/ISO Standards: Depending on the device, adherence to relevant IEC (International Electrotechnical Commission) or ISO (International Organization for Standardization) standards for safety and performance may be necessary.

Ensure that your device complies with these standards and any additional requirements specified by Roszdravnadzor.

national-cancer-institute-LxPrHCm8-TI-unsplash(1).jpg

Contact Us：

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


Last one: What should be considered after obtaining RZN certification for Class I medical devices?
The next one: What are the technical document requirements for RZN certification of Class I medical devices?
return