MMD-119    An Overview of GMP Requirement for Brazil and South Korea

• 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 Good Manufacturing Practices for Brazil and South Korea. 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 and South Korean regulatory process, led by an experienced trainer whom, in addition to being a medical device quality systems auditor and product approval reviewer, has nearly 3 decades of assessment, training and quality assurance as well as management system development experience. 

Participants will engage in exercises and discussion points, including considerations in harmonizing these requirements and those of the IMDRF with respect to medical devices regulatory compliance.

By the end of this course, participants will be able to:

• Explain the legislative and regulatory frameworks for medical devices in Brazil (ANVISA) and South Korea (MFDS/KFDA).
• Identify and apply risk classification principles and essential requirements for medical devices in both markets.
• Interpret clinical data, labelling, and post-market requirements specific to Brazil and South Korea.
• Develop and maintain compliant technical documentation, risk management files, and quality system processes.
• Navigate relevant standards, guidance documents, and inspection expectations for GMP compliance in Brazil and South Korea.

• Module 1 – Introduction & Legislative Framework
• Module 2 – Regulatory Framework & Risk Classification
  
• Module 3 – Essential Requirements & Role of Standards
  
• Module 4 – Clinical Data & Evidence
  
• Module 5 – Labelling & Language Requirements
  
• Module 6 – Post-Market Activities
  
• Module 7 – Risk Management
  
• Module 8 – Technical Documentation
  
• Module 9 – Quality Management Systems
  
• ​Module 10 – Guidance Documents & Regulatory Intelligence
  

This course is design for:

• Regulatory and quality staff responsible for preparing or hosting MDSAP audits / Anvisa inspection and/or KFDA / 3rd Party Audits
• Design personnel
• Internal and external auditors
• Organizations wishing to place their medical devices in Brazilian or South Korean markets

This is a ​3 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.