In Vitro Diagnostic (IVD) Product Registration and Notification

Request a quoteSpeak to our team

Next enrolment step

Choose your cohort

No cohorts are open at present. Contact the team about the next planned cohort.

01

Course description

A course specifically addressing ANVISA regulatory compliance for in vitro diagnostic (IVD) medical devices, covering risk classification, technical dossier structure, analytical and clinical performance requirements, and the specific aspects of IVD product applications.

02

Course objective

Equip participants to structure and submit IVD product regulatory applications to ANVISA based on the applicable RDC, correctly applying performance and metrological traceability requirements.

03

Course programme

16h of in-depth learning
  1. 01

    IVD risk classification

  2. 02

    IVD notification and registration pathways

  3. 03

    Analytical and clinical performance requirements

  4. 04

    Metrological traceability and reference standards

  5. 05

    Structuring the IVD technical dossier

  6. 06

    Labelling and Instructions for Use

  7. 07

    Electronic applications and registration maintenance

04

Who can attend?

  • Regulatory Affairs professionals, Technical Managers, clinical scientists, Quality managers and companies manufacturing, importing or distributing IVD products.

Certification

HSC Global Certificate Recognised by Exemplar Global RTP

Internationally recognised in more than 30 countries by Exemplar Global, with independent validation of the professional's technical competence.

Exemplar Global RTP seal
Photo of Lucilia Fialho

Instructor

Lucilia Fialho

Pharmacist with more than 20 years' experience in Quality Assurance and Regulatory Affairs for the healthcare product, in vitro diagnostic (IVD) and cosmetics industries. At HSC Global, she structures quality systems, manages ANVISA product and equipment registrations, and prepares companies to obtain their first GMP certificate (CBPF), coordinating multidisciplinary teams towards regulatory compliance.

  • ISO 13485:2016 Lead Auditor (BSI)
  • MDSAP Lead Auditor
  • MDR Lead Auditor, Regulation (EU) 2017/745
  • ANVISA IVD Specialist
  • Established track record of successful ANVISA Good Manufacturing Practice (CBPF) and Good Storage and Distribution Practice (CBPAD) audits
  • Quality Management System certifications and recertifications under ISO 13485 and ISO 9001
  • Areas of practice: Regulatory Affairs, Good Manufacturing Practice (GMP/CBPF), ANVISA Registration, IVD, Medical Device Vigilance and Quality Management Systems (ISO 13485 / ISO 9001)