[Affaires réglementaires] Les exigences réglementaires des juridictions du Medical Device Single Audit Program (MDSAP)

Durée de la formation

2 jours, 14h00

Compétences visées

Grâce à cette formation, vous acquerrez des connaissances sur les exigences réglementaires propres à chaque réglementation couverte par le MDSAP.
Cette formation vous aidera à vous préparer pour un audit MDSAP et vous permettra de déterminer si vos processus de SMQ internes sont en règle avec les exigences de l’audit MDSAP.

Formation dispensée uniquement en anglais.

Public ciblé

Professionnels du dispositif médical :

• Fabricants, Sous-traitants
• Personnel chargé d’Assurance Qualité et/ou Affaires Réglementaires

Objectifs de la formation

• Identifier les exigences réglementaires spécifiques à l’Australie, le Brésil, le Canada, les USA.

Programme

1. Australia
   • Principal Australian medical device legislation
   • Regulation of medical devices in Australia
   • Medical device registration stakeholders and their responsibilities
   • Medical device classification
   • Processes to supply a medical device in Australia
   • Conformity assessment, including TGA recognition of MDSAP certificates
   • Essential principles and differences with EU essential requirements
   • Application audits
   • Post-market requirements
   • Test
2. Brazil
   • Stakeholder Requirements
     
     
   • Brazilian GMP (BGMP)
   • Classification and Grouping
   • Marketing Authorization Registration Pathways & Requirements
   • Labeling
   • Additional Pre-Market Requirements
   • Post-Market Requirements
   • Medical Device Clinical Trials in Brazil
   • Test
3. Canada
   • Canadian Medical Devices Regulations
   • Classification of medical devices
   • Medical Device Licenses and amendments
   • Quality system requirements
   • Detailed review of RA relevant sections of the regulation
   • Maintaining compliance
   • Test
     
4. USA
5. 4.1 510(k)
   • 510(k) program overview
     
   • Use of product codes
   • Role of guidance documents & standards
   • 510(k) Structure and content
   • FDA review and decision process
   • Common problem areas
   • Tips for success
6. 4.2 De Novo
   • What is a De Novo?
   • When to Consider a De Novo?
   • Timelines for a De Novo?
   • How to Prepare a De Novo?
   • What to Expect during the Review Process?
   • What Are the Implications of a De Novo?
   • Tips for Success
7. 4.3 PMA
   • What is a PMA?
   • When to consider a PMA?
     
   • What are the timelines for a PMA?
     
   • How to prepare a PMA?
   • What to expect with the review process?
   • What are the implications of a PMA?
   • Tips for success
8. Test: Change control cases