Medical Device Registration - RDC 751/2022

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01

Course description

A comprehensive course on the ANVISA medical device notification and registration process, based on RDC 751/2022 and related legislation, covering risk classification, regulatory categorisation, structuring the technical dossier and electronic applications.

02

Course objective

Enable participants to independently manage ANVISA medical device regulatory processes, preparing robust technical dossiers and reducing requests for further information and application refusals.

03

Course programme

24h of in-depth learning
  1. 01

    Regulatory categorisation and risk classification (I, II, III, IV)

  2. 02

    Notification versus registration pathways

  3. 03

    Technical dossier structure under RDC 751/2022

  4. 04

    Labelling, Instructions for Use and essential requirements

  5. 05

    Good Manufacturing Practice certification

  6. 06

    Electronic applications through Solicita/ANVISA

  7. 07

    Maintenance, renewal and post-registration changes

04

Who can attend?

  • Regulatory Affairs professionals, Technical Managers, Quality managers, consultants, medical device manufacturers and importers.