Health Regulatory Compliance and Company Authorisation

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01

Course description

A course equipping professionals and companies to meet ANVISA health requirements for obtaining and maintaining the Operating Authorisation (AFE) and state and municipal health licences. Covers the regulatory framework applicable to medical device manufacturers, importers, distributors and warehouse operators.

02

Course objective

Enable participants to independently manage health regulatory compliance for medical device companies, reducing enforcement risks and ensuring compliance with the applicable RDC at every level of health surveillance.

03

Course programme

24h of in-depth learning
  1. 01

    Fundamentals of health regulation in Brazil (ANVISA, state and municipal health surveillance authorities)

  2. 02

    Operating Authorisation (AFE) and Special Authorisation (AE)

  3. 03

    State and municipal health licences (Alvará Sanitário)

  4. 04

    Technical responsibility and legal obligations

  5. 05

    Good Storage, Distribution and Transport Practice

  6. 06

    Electronic applications and process tracking

04

Who can attend?

  • Regulatory Affairs professionals, Technical Managers (RT), quality managers, entrepreneurs and consultants working on establishing, maintaining or bringing medical device companies into compliance.