Country Regulation Korea

This module will provide a broad overview of how local regulations are evolving in the context of the changing global landscape and the classifications system, regulatory pathways and product registration of MDs and IVDs in South Korea.

English

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3 hours

APACMed Certificate

Assessments

Interactive

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This module has been developed by a number of experts from South Korea.

About this Module

Purpose
Learning Objectives
Target Audience
Module Structure
Assessment
Certificate

Why should I enrol in this Module?

This module will provide a broad overview of how local regulations are evolving in the context of the changing global landscape and the classifications system, regulatory pathways and product registration of MDs and IVDs in South Korea.

Who should enrol in this Module? 

This Module is suitable for all Regulatory Affairs professionals or anyone with an interest in the regulation of medical devices.

How is this Module structured?

This is a self-paced, interactive Module.  It is divided into a number of individual topics so you can easily track your progress and manage your time.

You must watch all of the videos and presentations before the section will be marked as complete.

You can view the structure and individual topics below.

What kind of assessment do I need to do?

This Module contains a number of short knowledge checks and a final assessment.  

You will have unlimited attempts to pass each knowledge check.

What will I learn?

By the end of this module, you will have an understanding of:

  • Korean Health Authorities, relevant stakeholders and the Medical Device Act Regulation;
  • Pre-market registration in Korea;
  • GMP in Korea;
  • Post Market Requirements; and
  • IVD Regulation in Korea

When will I get my certificate?

At the completion of the course you will immediately have access to the certificate from APACMed.