When registering a Class I medical device with Roszdravnadzor (RZN) in Russia, the device must meet various standards and regulatory requirements to ensure its safety, effectiveness, and quality. These standards are primarily derived from Russian national regulations and Eurasian Economic Union (EAEU) technical regulations, as well as international standards that are recognized in Russia.

Key Standards for Class I Medical Device Registration in Russia

1. EAEU Technical Regulations

The primary regulatory framework for medical devices in Russia (and other member countries of the Eurasian Economic Union, EAEU) is the EAEU Technical Regulation No. 036/2016 (TR EAEU 036/2016) on the safety of medical devices, which establishes the safety and performance requirements for all medical devices marketed in Russia and other EAEU member states.

• TR EAEU 036/2016 applies to all medical devices, including Class I devices, and specifies requirements related to:

  • Safety: The device must not pose a risk to the health and safety of patients, users, or others under normal conditions of use.
  • Performance: The device must perform as intended without causing harm when used correctly.
  • Quality Control: Manufacturers must implement quality management practices to ensure that the devices meet regulatory and safety standards.
  • Risk Management: Even for Class I devices, a basic risk analysis must be provided, demonstrating that the device has been designed with safety in mind and potential risks have been minimized.

• Risk Classification: Class I devices are considered low-risk, and thus have fewer regulatory requirements than higher-risk devices. However, they still need to meet the essential safety and performance criteria.

2. Russian Federal Law on the Circulation of Medicines and Medical Devices

• The Russian Federal Law No. 61-FZ (dated April 12, 2010) on the Circulation of Medicines and Medical Devices governs the registration and regulation of medical devices in Russia.
• Article 21 of the law sets out the general requirements for the safety, efficacy, and quality of medical devices, which manufacturers must comply with to obtain registration with Roszdravnadzor.
• The law also defines the registration process and the need for manufacturers to submit technical documentation, including proof of compliance with safety standards and risk management practices.

3. GOST Standards (Russian National Standards)

• Medical devices in Russia must comply with the applicable GOST (Russian State Standards), which set forth the technical specifications for medical devices, including safety, performance, labeling, and manufacturing practices.
• Some relevant GOST standards for Class I medical devices include:
  • GOST R 50444-99: Medical devices – General requirements for safety.
  • GOST 31973-2012: Medical devices – Instructions for use and labeling requirements.
  • GOST R ISO 13485: Medical devices – Quality management systems – Requirements for regulatory purposes (this is equivalent to the ISO 13485 standard used internationally).

These GOST standards are often cited in the technical documentation and risk analysis to show compliance with Russian regulations.

4. ISO Standards (International Standards)

• Russia generally recognizes international standards for medical devices, particularly those developed by the International Organization for Standardization (ISO), which are aligned with EAEU regulations.
• For Class I devices, ISO 13485 (for Quality Management Systems) is the most relevant international standard. This standard outlines the requirements for a quality management system that consistently meets customer and regulatory requirements for medical devices.
• Other relevant ISO standards may include:
  • ISO 14971: Medical devices – Application of risk management to medical devices.
  • ISO 10993: Biological evaluation of medical devices (if applicable to the materials in the device).
  • ISO 60601: Medical electrical equipment (if the device involves electrical components).

5. Biocompatibility Standards

• Biocompatibility: Even for Class I devices, manufacturers must ensure that materials used in the device are biocompatible (i.e., safe for use in the human body). This is particularly important for devices in contact with the skin, mucous membranes, or internal organs.
• Compliance with ISO 10993 (Biological evaluation of medical devices) is typically required to demonstrate that the materials do not cause adverse reactions when in contact with the human body.

6. IEC Standards (International Electrotechnical Commission)

• If the Class I medical device has electrical components, it must comply with IEC 60601 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance).
• This standard covers the electrical safety and performance requirements for medical devices that are electrically powered or contain electrical components.

7. Packaging and Labeling Standards

• All Class I medical devices must meet packaging and labeling standards to ensure that the device is safely transported and used by the end user.
• The key regulations for packaging and labeling include:
  • EAEU TR 036/2016: Safety and performance requirements for medical devices, which includes requirements for labeling.
  • GOST 31973-2012: Requirements for the labeling and packaging of medical devices.
  • Russian Language Requirements: Labeling and instructions for use must be in Russian to ensure clarity for local users.

8. Post-market Surveillance and Reporting

• After the device is registered and placed on the market, manufacturers must comply with post-market surveillance requirements to monitor the safety and effectiveness of the device. This includes reporting adverse events, product recalls, and corrective actions to Roszdravnadzor.
• Class I devices may have less stringent post-market surveillance requirements compared to higher-risk devices, but manufacturers are still obligated to monitor their products and take necessary actions if safety concerns arise.

Summary of Standards for Class I Medical Device Registration in Russia

1. EAEU Technical Regulations (TR EAEU 036/2016) – Basic safety, performance, and risk management requirements.
2. Russian Federal Law No. 61-FZ – General legal framework for medical device circulation.
3. GOST Standards – Russian national standards for medical devices, including safety, quality, and labeling requirements.
4. ISO Standards – International standards recognized by Russia, including ISO 13485 (Quality Management), ISO 14971 (Risk Management), and ISO 10993 (Biocompatibility).
5. IEC Standards – If applicable, for electrical devices (IEC 60601 for electrical safety).
6. Biocompatibility – Compliance with ISO 10993 for devices in contact with the human body.
7. Packaging and Labeling – Must meet Russian-language labeling and packaging requirements.
8. Post-market Surveillance – Ongoing monitoring and reporting requirements after the device is on the market.

These standards ensure that the Class I medical device is safe, effective, and compliant with both Russian national regulations and international norms. It’s important to carefully document compliance with these standards during the registration process with Roszdravnadzor.

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