The Brazilian Health Regulatory Agency (ANVISA) has established clear guidelines for the compassionate use of medical devices in Brazil through RDC 608/2022. This regulation marks a significant step forward in enabling access to innovative medical technologies for patients with serious conditions and no satisfactory therapeutic alternatives.
What is Compassionate Use?
The Compassionate Use Program allows access to innovative medical devices not yet registered with ANVISA for patients with serious, debilitating illnesses. This program is especially valuable when no satisfactory therapeutic options are available in the country.
Eligibility Criteria
For a patient to qualify for the Compassionate Use Program, three conditions must be simultaneously met:
- The patient has a serious, debilitating disease
- There is no satisfactory therapeutic alternative available in Brazil
- The benefit-risk ratio of the requested medical device is favorable
Responsibilities of the Sponsor
The program sponsor holds several key responsibilities:
- Provide the medical device free of charge
- Ensure device availability for as long as it benefits the patient
- Monitor and document the product’s use
- Report serious adverse events to ANVISA
- Ensure device production follows Good Manufacturing Practices
Role of the Attending Physician
The attending physician plays a crucial role in the program, being responsible for:
- Justifying the device’s use through a medical report
- Properly storing the device
- Monitoring the patient and any adverse events
- Creating a follow-up schedule
- Reporting changes and adverse events to the sponsor
Patient Protection
The regulation includes various safeguards to protect patients:
- Free provision of the device
- Detailed information and consent form
- Comprehensive assistance in case of complications
- Personal data protection
- Freedom to accept or withdraw from treatment at any time
Timeline and Monitoring
The program has a maximum duration of 5 years for patient inclusion, beginning with the enrollment of the first participant. The sponsor must submit annual reports to ANVISA on the program’s progress and a final report within 90 days of program completion.
Final Considerations
The Compassionate Use Program represents a vital pathway for accessing innovative medical technologies for patients in critical situations. This regulation strikes a balance between the need for new treatments and patient safety, with clear responsibilities for all parties involved.
For further information on the Compassionate Use Program for medical devices, consult RDC 608/2022 in full or contact ANVISA.
📝 Access RDC 608/22
The original language version of this announcement is the authorized official version. Translations are provided for convenience and should refer to the original language text, which is the only legally binding version.
Click the link to access the Original Version
For any questions, contact Brisa Advisors for specialized regulatory support.
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