Class I medical device registration with Roszdravnadzor (RZN) in Russia refers to the regulatory process through which a low-risk medical device is officially recognized and approved for legal sale, use, and distribution within the Russian Federation. This registration ensures that the device complies with Russian medical device regulations and standards, making it available for healthcare professionals and consumers in Russia.

Key Points About Class I Medical Device Registration in Russia:

1. Classification of Devices:

   • Medical devices in Russia are classified based on their risk levels. The classification system is generally aligned with international standards such as those from the European Union or FDA in the U.S.
   • Class I devices are considered low-risk devices, typically non-invasive, simple, and with a minimal potential for harm when used properly.
   • Examples of Class I devices include bandages, wheelchairs, non-sterile surgical instruments, and certain diagnostic tools.

2. Regulatory Framework:

   • The registration of medical devices in Russia is governed by Roszdravnadzor (RZN), which is the regulatory body responsible for overseeing the quality, safety, and efficacy of medical devices in Russia.
   • The registration process for Class I devices is less complex and less rigorous compared to higher-class devices (Class II, Class III), and typically does not require extensive clinical trials or technical evaluations.

3. The Registration Process:

   • To register a Class I medical device with RZN, manufacturers or authorized representatives must submit a registration application along with technical documentation, such as:
     • Device description, intended use, and specifications.
     • Conformance with Russian technical standards (such as TR 027/2012).
     • Proof of safety and performance (usually provided through test reports or certifications from other regions like the EU or USA).
     • Proper labeling and user instructions (in Russian).
   • The device must meet the requirements set out in Russia’s Technical Regulations on Medical Devices (TR 027/2012) and other applicable standards.

4. Issuance of Registration Certificate:

   • After submission and review, RZN will issue a registration certificate for Class I medical devices that meet the necessary requirements. This certificate confirms that the device is authorized for sale and use in Russia.
   • The registration is typically perpetual, meaning it does not need to be renewed unless significant changes are made to the device.

5. Importance of Registration:

   • Market Access: The registration allows the manufacturer or authorized representative to distribute and sell the device legally within Russia.
   • Compliance: Registration ensures that the device complies with the safety, quality, and labeling standards required by Russian law, which is crucial for consumer protection and market trust.
   • Post-Market Surveillance: After registration, the device must be monitored for safety and performance. Any issues or adverse events must be reported to RZN.

Conclusion:

Class I medical device registration with Roszdravnadzor in Russia allows a manufacturer (or their authorized representative) to legally market low-risk medical devices within the country. The process ensures that the device meets Russia's safety and regulatory standards, facilitating its use in the Russian healthcare market. The process is simpler and faster compared to higher-risk device registrations, but it still requires proper documentation, compliance with local standards, and adherence to regulatory guidelines.

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