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.

Here are the key standards and regulatory frameworks that apply to Class 2A medical device registration in Russia:

1. Russian Federal Law and Technical Regulations

• Federal Law No. 323-FZ "On the Basics of Health Protection of Citizens in the Russian Federation":
  This law governs the healthcare system in Russia and includes regulations for medical devices, including requirements for safety, efficacy, and quality.

• Technical Regulations for Medical Devices (approved by Decree No. 982 of the Government of the Russian Federation, December 2011):
  This regulation outlines the general requirements for medical device registration in Russia. It covers technical, safety, and performance requirements for medical devices marketed in Russia.

2. Russian National Standards (GOST R)

• GOST R 52379-2005: Medical devices — General requirements for safety. This standard is closely aligned with international safety standards, ensuring that devices meet basic safety requirements.

• GOST 25779-90: Medical devices — Packaging requirements: Specifies packaging standards for medical devices, ensuring safe and secure packaging for transportation and use.

• GOST 52447-2005: Medical devices — Terms and definitions: Provides definitions for the terminology used in Russian medical device regulation.

• GOST R 51617-2000: Sterilization of medical devices: Defines requirements for the sterilization process of medical devices, which is relevant for certain Class 2A devices that need sterilization prior to use.

• GOST R 51524-2004: Medical devices — Labeling and instructions for use: Specifies labeling and instructions for use, ensuring clear and complete instructions are provided in Russian for devices sold in Russia.

3. International Standards for Medical Devices

While Roszdravnadzor’s regulations are based on Russian law, many of the standards required for medical device registration align with international standards, particularly those from the European Union and ISO.

• ISO 13485: Medical devices — Quality Management Systems (QMS).
  A mandatory standard for manufacturers to ensure the quality management system for the production of medical devices. This standard is typically required for all devices, including Class 2A, and is a key part of the registration process.

• ISO 14971: Risk Management for Medical Devices.
  This standard outlines the process for identifying and managing risks throughout the lifecycle of a medical device. For Class 2A devices, a risk analysis (as per ISO 14971) must be provided as part of the registration process.

• ISO 10993: Biological evaluation of medical devices.
  This standard is used to evaluate the biocompatibility of materials in medical devices that come into contact with the human body. This is critical for Class 2A devices that involve direct or indirect contact with patients.

• IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment.
  This standard applies to electrical medical devices (e.g., diagnostic or therapeutic equipment) and specifies requirements for safety and performance.

• IEC 60601-1-2: Electromagnetic compatibility (EMC) for medical devices.
  Relevant for Class 2A medical devices that contain electrical components, this standard specifies the electromagnetic compatibility (EMC) requirements to ensure the device does not interfere with other devices or suffer interference that could impact its performance.

• IEC 62304: Software life cycle processes.
  For medical devices that contain software, IEC 62304 defines the processes necessary for the design, development, and maintenance of software used in medical devices, ensuring safety and effectiveness.

4. CE Marking (for Devices Already CE Certified)

If a medical device is already CE-marked in the European Union, it can be used as a basis for registration in Russia, as Russia recognizes the CE marking for certain medical devices under its Eurasian Economic Union (EAEU) regulations. For Class 2A medical devices, the CE certificate and the accompanying Declaration of Conformity can be part of the registration dossier for submission to Roszdravnadzor.

Important points:

• The CE Marking and associated documentation must be translated into Russian and submitted to Roszdravnadzor.
• The Declaration of Conformity from the manufacturer must confirm that the device meets relevant European medical device regulations.

5. EAEU Technical Regulations (for Member States)

Russia is part of the Eurasian Economic Union (EAEU), which includes Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russia. The EAEU Technical Regulation TR CU 019/2011 "On the Safety of Medical Devices" applies to all medical devices, including Class 2A devices, intended for the market within EAEU member states.

Key provisions include:

• TR CU 019/2011: Ensures that medical devices meet safety, quality, and performance requirements before they are marketed in any EAEU member state, including Russia.
• Devices that meet the EAEU regulations may be eligible for the EAEU Declaration of Conformity or EAEU Certificate of Conformity, which can be used as part of the Russian registration process.

6. Clinical Trials and Performance Data

For Class 2A medical devices, clinical trials or clinical evaluation reports may be required to demonstrate the safety and performance of the device, particularly if the device involves novel technology, new indications, or interacts directly with the human body. The clinical data must meet the following standards:

• ISO 14155: Clinical investigation of medical devices for human subjects — Good clinical practice.
  This standard provides guidelines for clinical trials involving medical devices, ensuring the investigation follows ethical and regulatory standards.

• ISO 20916: Clinical performance studies of in vitro diagnostic medical devices — Good clinical practice.
  Relevant if the Class 2A device is an in vitro diagnostic (IVD) device, this standard outlines the requirements for conducting clinical performance studies.

Contact Us：

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