MMD-116    Overview of Brazilian GMP for Medical Devices & IVD's (RDC 665/2022)

• Overview
• Course Objectives
• Course Content
• For Whom
• Schedule and Hours

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This course is designed to provide participants with the knowledge on medical device regulations pertaining to the RDC 665/2022 which replaces resolution RDC 16/2013 and the IN 08/2013 as the Brazilian Good Manufacturing Practices (BGMP) for Medical Devices and In Vitro Diagnostic Devices (IVD’s). Internal and external auditors and personnel responsible for quality systems for medical device manufacturers will benefit from this course.  Participants will gain an overview of the requirements of the Brazilian regulatory process.

Participants will be led by an experienced trainer whom, in addition to being a CE Marking quality systems auditor and product approval reviewer, has over 3 decades of assessment, training and quality assurance as well as management system development experience. Participants will lead through exercises and discussion points, including considerations in harmonizing these requirements and the IMDRF with respect to medical devices regulatory compliance

Upon completion this programme, participants are able to:

• Understand the Brazilian medical device regulatory framework, including key legislative requirements.
  
• Interpret the key provisions of RDC 665/2022 in relation to medical devices and IVDs.
  
• Recognize the relationship between RDC 665/2022, RDC 687/2022, and RDC 291/2019.
  
• Understand risk classification principles and essential requirements for medical devices.
  
• Identify key standards, clinical data requirements, and labeling regulations for compliance.
  
• Understand post-market activities, risk management, and quality system requirements.
  
• Interpret technical documentation and guidance documents necessary for regulatory compliance.
  

• Section 1: Overview of the Medical Device Legislature
• Section 2: Overview of the Regulatory Framework
  
• Section 3: Relationship with resolution RDC 687/2022, and resolution RDC 291/2019
  
• Section 4: Introduction to Risk Classification
  
• Section 5: Introduction to the Essential Requirements for Medical Devices
  
• Section 6: Overview of the Role of Standards
  
• Section 7: Introduction to Clinical Data
  
• Section 8: Overview of Labelling Requirements
  
• Section 9: Overview of Post Market Activities
  
• Section 10: Overview of Risk Management for Medical Devices
  
• Section 11: Overview of Technical Documentation
  
• Section 12: Overview of Quality Systems for Medical Device
  
• Section 13: Overview of Guidance Documents
  

This course is designed for :

• Medical Device & IVD Manufacturers
• Regulatory Affairs Professionals
• Quality Assurance & Compliance Officers
• Clinical and Technical Documentation Specialists
• Medical Device Importers & Distributors
• Healthcare Professionals & Consultants

This is a ​2 days programme.
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This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
 
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.

We are HRD Corp (Human Resource Development Corporation) Registered Training Provider.
​All of our training modules are claimable under HRD Corp.