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 — a device and a drug or biologic — combined to produce a single integral product.
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.