After the registration of a Class I medical device with Roszdravnadzor (RZN) in Russia, there are several important rules and requirements that manufacturers must continue to follow in order to remain compliant with Russian regulations. These rules cover post-market surveillance, reporting obligations, device labeling, quality management, and other ongoing responsibilities. Here’s an overview of the key requirements that must be adhered to after receiving approval for Class I medical device registration in Russia:

1. Post-Market Surveillance (PMS)

• Monitoring Device Safety and Performance:
  • Continuously monitor the safety and performance of the device in the market. Ensure that any issues related to the device’s safety, efficacy, or quality are promptly addressed.
• Collect User Feedback:
  • Actively collect feedback from users (healthcare professionals and patients) regarding the device’s performance. This feedback is critical for identifying potential issues and for continuous improvement.
• Risk Management:
  • Maintain an ongoing risk management process to identify and assess any new risks that may arise from the use of the device post-market.
• Risk Mitigation:
  • If any new risks or adverse events are identified, you must take corrective actions such as updating the user manual, labeling, or conducting a recall if necessary.

2. Adverse Event Reporting

• Report Adverse Events and Incidents:
  • Manufacturers must report any adverse events (including incidents, side effects, or failures) to Roszdravnadzor within the required timeframes:
    • Serious incidents must be reported immediately (within 10 working days).
    • Non-serious incidents must be reported quarterly.
• Field Safety Corrective Actions:
  • If the device poses a safety risk, manufacturers may need to initiate a field safety corrective action (such as a recall or safety alert) and inform Roszdravnadzor and end-users.
• Incident Investigation:
  • Conduct an investigation into the root causes of any adverse events and take corrective actions to mitigate future risks.
• Monitoring and Reporting Updates:
  • Keep Roszdravnadzor updated on any corrective actions taken or planned in response to reported incidents.

3. Device Labeling and Packaging Requirements

• Maintain Compliance with Labeling Regulations:
  • All labels and packaging must continue to comply with Russian regulations, including language requirements (labels must be in Russian) and the inclusion of mandatory information such as the manufacturer’s name, device purpose, batch/serial number, expiration date, and safety warnings.
• Update Labeling as Needed:
  • If any changes are made to the device (e.g., changes in indications for use, warnings, or contraindications), the labeling must be updated accordingly and re-submitted to Roszdravnadzor if required.
• Compliance with GOST Standards:
  • Ensure that the labeling continues to meet GOST R 50444-99 and other applicable Russian standards, including the use of correct safety symbols and product identification.

4. Maintenance of Quality Management System (QMS)

• ISO 13485 Compliance:
  • Maintain an ISO 13485 certified Quality Management System (QMS). While Class I devices are considered low risk, maintaining an effective QMS ensures that your device is consistently produced in compliance with good manufacturing practices (GMP).
• Regular Internal Audits:
  • Conduct regular internal audits of the QMS to ensure ongoing compliance with regulatory requirements and the continuous improvement of the manufacturing processes.
• Document Control and Record Keeping:
  • Ensure proper document control and record-keeping for all relevant aspects of the device’s lifecycle, including manufacturing, testing, quality assurance, and post-market surveillance.

5. Registration Maintenance and Renewal

• Maintain Registration with Roszdravnadzor:
  • Ensure that your registration with Roszdravnadzor remains valid. For most Class I devices, the registration is perpetual unless there are significant changes to the device (e.g., new features, composition, or manufacturing processes).
• Update Device Information:
  • If there are any changes to the device’s technical specifications, indications for use, or manufacturer details, you must submit an updated registration application to Roszdravnadzor. Such changes may require a reassessment of the registration.
• Renewal (If Required):
  • Some registrations may require periodic renewal. Although Class I devices typically do not have specific expiration dates, manufacturers should verify whether their registration requires re-submission at regular intervals (e.g., every 5 years).

6. Ongoing Regulatory Compliance

• Adherence to New Regulatory Changes:
  • Stay up-to-date with any changes in Russian regulations or the EAEU (Eurasian Economic Union) regulations that could affect the medical device. For example, updates to the Technical Regulations or GOST standards might impact the labeling, safety testing, or manufacturing processes for medical devices.
• Monitoring for New Standards:
  • Watch for updates to standards such as GOST R 50444-99, GOST 29189, and ISO 13485. Ensure that your device continues to meet the latest requirements.

7. Import and Distribution Compliance

• Customs and Importation Compliance:
  • If your device is imported into Russia, ensure compliance with customs regulations, including appropriate customs declarations and other importation documentation.
• Distribution Responsibilities:
  • Ensure that distributors comply with Russian regulations regarding the storage, handling, and distribution of medical devices. Distributors should be aware of their responsibilities, including reporting any adverse events or issues with the device.

8. Prepare for Inspections or Audits

• Roszdravnadzor Inspections:
  • Be prepared for possible inspections or audits by Roszdravnadzor or other Russian authorities. These inspections may focus on the manufacturing processes, quality management system, and post-market activities related to your device.
• Audit Documentation:
  • Maintain proper documentation of the manufacturing process, risk assessments, and adverse event reports, as these may be requested during audits or inspections.

9. Device Recalls and Corrective Actions

• Recall Procedures:
  • If safety issues or defects are discovered with the device, you must initiate a recall and notify Roszdravnadzor and the public as required by Russian regulations.
• Corrective and Preventive Actions (CAPA):
  • Implement corrective actions (e.g., design changes, quality control adjustments) and preventive actions to mitigate the risk of adverse events. Ensure that these actions are documented and reported to Roszdravnadzor as necessary.

10. Reporting to Roszdravnadzor

• Annual Reports:
  • Depending on the nature of the device, you may be required to submit annual reports to Roszdravnadzor on the performance of the device in the market. This includes data from post-market surveillance activities, safety reports, and information on any corrective actions taken.
• Safety Reports:
  • Ensure timely submission of any required safety reports related to adverse events, incidents, or device modifications.
• Additional Notifications:
  • Notify Roszdravnadzor if there are any changes to the manufacturer, authorized representative, or the registration information.

Summary of Key Post-Registration Requirements

1. Post-market surveillance and monitoring of device performance.
2. Adverse event and incident reporting to Roszdravnadzor within specified timeframes.
3. Labeling and packaging compliance, including updating labels as needed.
4. Maintenance of a quality management system (e.g., ISO 13485).
5. Ongoing registration maintenance and submission of updates for any significant changes.
6. Compliance with new regulatory requirements and standards.
7. Importation and distribution compliance with Russian laws.
8. Preparation for audits and inspections by Roszdravnadzor.
9. Device recalls and corrective actions if necessary.
10. Regular reporting to Roszdravnadzor, including annual performance reviews and safety reports.

By following these post-registration rules and requirements, manufacturers can ensure the continued compliance of their Class I medical device in Russia, maintain market access, and uphold product safety and quality.

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