PD01 Advances In The Incorporation Of Medical Devices: A Case Study On Technology Developed By A Brazilian University
Fotini Toscas, Nadja Mayrink, Vania Cristina Canuto Santos, Luciene Bonan, Eduardo Dias · 2025
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Description
Fotini Toscas and co-authors review how Brazil's health technology assessment body has learned to judge medical devices, published in 2025. Devices are harder to evaluate than drugs because clinical and cost evidence is often thin. The committee, CONITEC, received 122 incorporation requests in twelve years, about a tenth for devices, mostly from outside applicants. The team combed regulations, committee records, and a tracking dashboard, then zoomed into one case.
In 2022 the committee restructured, adding subcommittees devoted to devices. The case study, a university-developed dynamic phototherapy, was rejected in 2020 and approved on re-review in 2023 after fuller evidence. The authors credit specialist involvement and real-world data for the turnaround. They present the evolution as a model for fairer, sharper device decisions.
Catalog record
| CREATOR | Fotini Toscas, Nadja Mayrink, Vania Cristina Canuto Santos, Luciene Bonan, Eduardo Dias |
|---|---|
| YEAR | 2025 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 2 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |