The Brazilian Health Regulatory Agency (ANVISA) established a resolution on the compassionate use of medical devices, through the submission and approval of programs adhering to specific criteria.
The Brazilian Health Regulatory Agency (ANVISA), through RDC Resolution n.º 608/2022, established the conditions for submission and approval of compassionate use programs for medical devices, i.e., the clinical application of medical devices that are still undergoing their validation processes in the treatment of patients in severe clinical condition. According to ANVISA, the resolution establishes a mechanism through which patients under clinical supervision may benefit from accessing promising medical devices, similar to the mechanisms applied in other countries.
As provided in the third article of the resolution, the approval of such programs is limited to situations when no satisfactory therapeutic alternative is available for treating the specific clinical condition, and the employment of the new medical device, based on a conclusive scientific report (see article 4), provides a favorable risk-benefit clinical assessment to the patient’s treatment. The procedures for submission and approval of compassionate use programs for medical devices are described in chapter “II” (articles 6 to 10), while attributions and liabilities are provided in chapter “III” (articles 11 to 14).
Regarding the oversight of the compassionate use, the submission of annual reports to ANVISA is provided in chapter “IV” (articles 15 to 18). The rules for altering and terminating programs, which may last up to five years, counted from the inclusion of the first patient, are provided in articles 19 to 23. As provided in article 24, imports of medical devices destined for compassionate use must adhere to the rules of RDC Resolution n.º 81/2008 (border control for products regulated by ANVISA), specifically chapter “XXVI”.
The annex to the new resolution is also available here. Additionally, ANVISA published a guide on the submission and approval process, available on its website (only in Portuguese).
