The term "2A class medical device registration in Russia with RZN" refers to the process of obtaining official approval from Roszdravnadzor (RZN), the Russian Federal Service for Surveillance in Healthcare, to market and use a Class 2A medical device within Russia. Here’s what it entails:

Key Elements of the Definition

1. Class 2A Medical Devices

• Class 2A refers to a category of medical devices with medium risk to patients and users.
• These devices typically have direct or short-term contact with the human body, but their impact on health is moderate.
• Examples of Class 2A devices:
  • Diagnostic ultrasound equipment.
  • Surgical drapes.
  • Dental curing lights.
  • Contact lenses.

2. Registration in Russia

• Registration is a mandatory regulatory process to ensure the safety, efficacy, and quality of medical devices before they can be imported, distributed, or used in Russia.
• This involves compliance with TR CU 019/2011, the EAEU technical regulation governing the safety of medical devices.

3. Role of RZN

• Roszdravnadzor (RZN) is the Russian authority responsible for overseeing the registration, surveillance, and compliance of medical devices in the country.
• RZN ensures that devices meet Russian and Eurasian Economic Union (EAEU) standards for safety, performance, and labeling.

Purpose of Registration

The primary purpose of registering a Class 2A medical device with RZN is to:

1. Ensure Patient Safety: Verify that the device operates safely and effectively.
2. Regulatory Compliance: Demonstrate adherence to Russian and EAEU regulations.
3. Market Authorization: Gain legal approval to manufacture, import, and sell the device in Russia.

Process Overview

To achieve registration:

1. The manufacturer submits detailed documentation (technical files, test reports, clinical data, etc.).
2. The device undergoes safety and performance testing in accredited Russian laboratories.
3. RZN reviews the submitted data and, if compliant, issues a Registration Certificate allowing legal sale and use in Russia.

Legal and Commercial Importance

Without RZN registration:

• A device cannot be legally imported or sold in Russia.
• Manufacturers face penalties for non-compliance.
• Medical institutions and users cannot purchase or deploy the device.

Conclusion

In summary, 2A class medical device registration with RZN ensures that a medium-risk medical device meets Russian safety and regulatory requirements, enabling its lawful distribution and use in the Russian market.

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