Responsável Técnico — Obligation for Importers
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 appointed and 30 days to prevent AFE suspension. The incoming RT must meet same eligibility criteria and professional council registration requirements.
Verify all information against official ANVISA sources before making regulatory decisions.
The Responsável Técnico must maintain active professional registration with their respective council (CREA, CRM, CFF, COREN, CFBM, CFBio, CFO, or equivalent) and comply with continuing professional development requirements set by those councils. Professional registration must be renewed according to each council's schedule (typically every 2–3 years). Proof of active registration must be provided to ANVISA upon request.