Responsável Técnico — Obligation for Importers
BR-unique
Every company holding an AFE in Brazil — including medical device importers — must appoint a Responsável Técnico (RT), a licensed professional registered with the relevant professional council (Conselho). This is a Brazilian law requirement with no direct equivalent in most other regulatory frameworks.
Eligible professions for Responsável Técnico (medical devices)
The eligible professions depend on the device type:
| Device type | Eligible RT professions |
|---|---|
| General medical devices | Engineer (CREA), Physician (CRM), Pharmacist (CFF), Nurse (COREN), or other health professional |
| IVDs (diagnostics) | Pharmacist (CFF), Biochemist (CFBM), Physician (CRM), or Biologist (CFBio) |
| Dental devices | Dentist (CFO) or eligible general health professional |
| Radiation-emitting devices | Physicist or Engineer (CREA) |
RT responsibilities
The RT is personally and professionally responsible for:
- Technical supervision of all regulatory activities;
- Signing ANVISA submissions and declarations of GMP compliance;
- Ensuring NOTIVISA adverse event reports are filed on time;
- Representing the company in ANVISA inspections; and
- Verifying that imported products comply with their registered specifications.
A company without an active RT faces immediate AFE suspension risk. If the RT leaves the company, a replacement must be registered with ANVISA within the timeframe specified by the regulation.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.