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Resource Library for Medical Device Professionals

11 total results. Show all resources.
South Korea

In Depth: South Korea Medical Device Approval and Compliance

This video series about South Korea's medical device market shows you the process and identifies the key concepts to know before you begin.

15 minutes
Apr 7, 2015
South Korea

Medical Device Registration in South Korea

An overview of the medical device regulations in South Korea, including the QMS compliance, classification, and submission requirements.

16 pages
Aug 27, 2015
South Korea

Introduction to South Korea Medical Device Approval Process

This four minute video provides an overview of South Korea's medical device registration process.

4 minutes
Sep 26, 2015
Download the Chart on the Regulatory Approval Process in South Korea
South Korea

South Korea MFDS Regulatory Approval Process for Medical Devices

This chart illustrates the steps in South Korea's MFDS medical device approval process and includes a timeline of expected approval.

2 pages
Aug 29, 2013
South Korea

What To Expect From Your Regulatory Representative

Are you planning to export your device to other medical device markets? Most countries require you to have a physical presence in that market. If you do not have an office there, you can appoint an independent representative to meet this need.

7 min
Nov 22, 2016
Fill out our short form to request information about South Korea
South Korea

Get smart about South Korea in 1 hour

Thinking about entering the South Korean market for the first time? Understanding the MFDS regulatory requirements can be overwhelming and confusing. We assembled a packet that includes the basic information you need before deciding to enter this market.

1 page
Jun 5, 2017
South Korea

Medical Device Consulting Services for South Korea

Interested in selling your medical device or IVD in South Korea? Emergo offers a wide range of regulatory, representation, QA and other services for companies looking to enter this market.

Nov 6, 2009
South Korea

MFDS - South Korea Ministry of Food and Drug Safety

Learn about the regulatory structure in South Korea and major medical device regulations.

1 page
Feb 12, 2014
Compare the time, cost and complexity of getting regulatory approval for medical devices
South Korea

Time, Cost and Complexity of Regulatory Approvals Worldwide

Use this interactive table to estimate how long it takes to gain approval in popular markets worldwide, along with associated costs.

Interactive Page
Aug 25, 2015
Learn about the South Korean MFDS regulations which apply to medical devices
South Korea

South Korea Medical Device Regulations

A comprehensive list of medical device regulations in South Korea with links to the original documents.

Downloadable PDFs
Jun 24, 2011