The National Health Surveillance Agency (ANVISA) has established clear guidelines for the compassionate use of medical devices through Resolution RDC 608/2022, published on March 2, 2022. This resolution outlines the requirements for submission and approval of compassionate use programs for medical devices not yet registered in Brazil. The rule is the result of ANVISA’s Public Consultation No. 1,049/2021, which received over 120 contributions from the regulated sector.
Key points of the resolution include:
- Patient eligibility criteria:
- A severe debilitating disease that substantially impairs the performance of daily life tasks or a chronic illness that, if left untreated, will progress in most cases.
- Absence of satisfactory therapeutic alternatives in the country for the treated condition.
- A favorable benefit-risk ratio for the requested medical device.
- Responsibilities of sponsors or CROs:
- Provide the device free of charge if there is a benefit from the intervention.
- Ensure proper storage and monitor its use.
- Notify ANVISA of serious adverse events within 15 calendar days (7 days in the event of death).
- Provide resources for full assistance in case of complications.
- Ensure that the device is manufactured according to good manufacturing practices.
- Submit individualized annual reports to ANVISA.
- Notify ANVISA of any changes to the program.
- Role of the attending physician: justify the use, monitor the patient, and report complications.
- Patient consent: a detailed informed consent form is required.
- Regulatory oversight: ANVISA will issue a specific authorization document (CEE-UCDM) for approved programs.
- Program termination: it can occur when the product is registered, at the request of the researcher, CRO, or attending physician, without prejudice to patients already included.
This resolution demonstrates Brazil’s commitment to balancing patient access to innovative treatments with necessary safeguards. It provides a structured path for patients with severe conditions to access potentially life-saving devices while ensuring proper monitoring and regulatory oversight.
For medical device companies and healthcare professionals, understanding these requirements is crucial to successfully implementing compassionate use programs in Brazil. It is worth noting that custom-made, patient-specific, or adaptable medical devices continue to be regulated by RDC No. 305/2019.
📝 Access the RDC 608/22 :
- The translated version in English is available here: RDC – 608/2022
The text in the original language of this announcement is the official authorized version. The translations are provided for convenience only and should refer to the text in the original language, which is the only version of the text that has legal effect.
If you have any questions, contact Brisa Advisors for specialized regulatory support.
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