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Borderline & Combination Products

See also Borderline & Combination Products for the consulta de enquadramento process.

The presence of a pharmacological component typically elevates the device class:

  • Device with medicinal substance as principal action → drug typically regulated as a (may be co-regulated by ANVISA's GGMED depending on the combination's characteristics)
  • Device with medicinal substance as ancillary → medical device (typically Class IV)
  • Drug-eluting stents, antibiotic-coated catheters → generally Class IV

Practical steps: Determine primary mode of action → submit consulta de enquadramento if uncertain → prepare dossier addressing both components → coordinate with GPRODS and GGMED as directed by ANVISA.

Official sources

Verify all information against official ANVISA sources before making regulatory decisions.

Device with medicinal substance as principal action → drug typically regulated by ANVISA's GGMED (may also involve GPRODS depending on the combination's characteristics)