Borderline & Combination Products
Brazil's borderline product framework is managed directly by ANVISA through a formal classification consultation process (consulta de enquadramento). Unlike the US FDA (which uses a lead-agency determination via the Office of Combination Products), Brazil's determination is made by ANVISA's relevant product directorate.
The borderline challenge
Many products sit at the intersection of two or more regulatory categories:
- Device + drug — e.g., drug-eluting stents, antibiotic-coated catheters, haemostatic sponges
- Device + biologic — e.g., scaffolds seeded with cells
- Device + cosmetic — e.g., dermal fillers with or without medical claims
Combination products (produtos combinados)
A combination product consists of two or more regulated components — typically a device combined with a drug or biologic — integrated to produce a single unified therapeutic product where the components cannot be separated without loss of intended function.
How classification is determined
The primary (principal) mode of action determines the lead regulatory pathway. This is the mechanism by which the product achieves its intended therapeutic or diagnostic effect. Secondary mechanisms do not change classification.
| Primary mode of action | Lead pathway |
|---|---|
| Mechanical/physical (device) | Medical device — GPRODS |
| Pharmacological/metabolic (drug) | Drug — GGMED |
| Immunological/biological | Biological — GBIO |
Seeking a classification opinion
Submit a consulta de enquadramento via ANVISA's Peticionamento Eletrônico. ANVISA will provide a formal opinion on which regulatory category applies.
Official resources
Seeking a classification opinion
What to include in your submission: Clearly describe the product's intended purpose, mechanism of action, components, and how each component contributes to the final therapeutic effect. Provide evidence or scientific literature supporting your proposed classification. ANVISA typically responds within 30–60 days with a formal written opinion (parecer técnico).