HSC - Regularization of Medical Devices

Training modules

Improve your knowledge in medical device regularization through six main objectives that ensure excellence and compliance.

Module 1

Introduction to health regularization and company regularization

Content

Decree 8,077/2013
SNVS Competencies
Organization of Health Surveillance Actions (ANVISA/State VISA/Municipal Visa) (RDC 560/2021)
National Health Surveillance Agency (Anvisa)
⁠Health Product Concept
Health Product Publications
Electronic Petition
Process Monitoring
Anvisa manifestations
Secondary petitions
Uploading instructions for use (RDC 431/2020)
Ownership transfer
Operating License (LF)
⁠Company Operating Authorization (AFE)
Certificate of Good Manufacturing and Control Practices (CBPF)
⁠MDSAP Certificate

Module 2

Health Product Project Management and Documentation

Content

Introduction to project management
Design and development control
Project planning and development
Design and development inputs
Design and development output
Critical analysis of design and development
Design and development verification
Design and development validation
Project Transfer
Project Release
⁠Control of design and development changes
RHProj x RMP x RMP

Module 3

Pre-Clinical Project Assessment

Content

Security and Performance Assessment
Biocompatibility Assessment;
Usability Assessment;
Sterilization Assessment;
Reprocessing Assessment;
Software Assessment;
Stability Assessment;
Packaging Assessment;
⁠Clinical Assessment;
Inmetro Certificate (Inmetro Ordinance 384/20 and Anvisa IN 283/24)
Anatel approval

Module 4

ISO 14971 Medical Products Risk Management

Module 5

Usability of medical devices IEC 62366-1

Module 6

Software applied to Medical devices

Content

SaMD
IEC 62304 Software Life Cycle
Cybersecurity

Module 7

Biocompatibility ISO 10993-1

Module 8

Safety and performance of medical devices IEC 60601-1

Module 9

Electromagnetic Compatibility of Medical Devices IEC 60601-1-2

Module 10

Introduction to Medical Device Registration

Updated with RDC 751/2022

Content

Anvisa Processes: Petition of Origin and Secondary Petition
Types of petitions
Product Health Framework (Risk Classification)
Notifications x logs
⁠Changes
Revalidation
Cancellation
Certificate of Conformity for equipment under the Health Surveillance regime
Technical dossier (overview)
Economic Information Report

Module 11

Notification and Registration of medical devices

Essential safety and efficacy requirements applicable to health products.Registration of medical devices

Content

Part A
Technical Dossier (Class I and II)
Initial notification petition
Publication of the Notification
Notification Change
Notification Revalidation
Cancellation of Notification

Part B
Technical Dossier (class III and IV)
Initial Registration Petition
Registry Publication
Change of Registration
Revalidation of Registration
Cancellation of Registration

Module 12

In vitro medical device registration

Essential safety and performance requirements for medical devices and in vitro diagnostic (IVD) medical devices

Content

Part A
IVD Technical Dossier (Class I and II)
IVD notification initial petition
Publication of IVD Notification
Change of IVD Notification
Revalidation of IVD Notification
Cancellation of IVD Notification

Part b
IVD Technical Dossier (class III and IV)
IVD Registration Initial Petition
Publication of the IVD Registry
Change of IVD Registration
Revalidation of IVD Registration
Cancellation of IVD Registration

Module 13

Post-market control and technovigilance

Content

Post market concepts
Technical assistance
Import, sale and donation of used or refurbished medical devices (RDC No. 579)
Used medical devices
Refurbished medical devices.
Customer complaints: control and monitoring
Notification to Health Authorities (RDC67/2009 and amendments)
Field actions (RDC 551/21)
Product recall (RDC 551/21)

Regularization of
Medical Devices

Discover HSC
Global and
our solutions.

Training modules

Introduction to health regularization and company regularization

Health Product Project Management and Documentation

Pre-Clinical Project Assessment

ISO 14971 Medical Products Risk Management

Usability of medical devices IEC 62366-1

Software applied to Medical devices

Biocompatibility ISO 10993-1

Safety and performance of medical devices IEC 60601-1

Electromagnetic Compatibility of Medical Devices IEC 60601-1-2

Introduction to Medical Device Registration

Notification and Registration of medical devices

In vitro medical device registration

Post-market control and technovigilance

Transform Your Career in Medical Devices

Regularization ofMedical Devices

Discover HSCGlobal andour solutions.

Training modules

Introduction to health regularization and company regularization

Health Product Project Management and Documentation

Pre-Clinical Project Assessment

ISO 14971 Medical Products Risk Management

Usability of medical devices IEC 62366-1

Software applied to Medical devices

Biocompatibility ISO 10993-1

Safety and performance of medical devices IEC 60601-1

Electromagnetic Compatibility of Medical Devices IEC 60601-1-2

Introduction to Medical Device Registration

Notification and Registration of medical devices

In vitro medical device registration

Post-market control and technovigilance

Transform Your Career in Medical Devices

Regularization of
Medical Devices

Discover HSC
Global and
our solutions.