Resource Library for Medical Device Professionals

12 total results. Show all resources.

South Korea's complex regulatory requirements can be difficult to navigate, especially for regulatory professionals not fluent in Korean. In this free webinar, we will take a closer look at medical device registration requirements in South Korea.watch now

Webinar | 1 hour recorded webinar

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

Process Chart | 2 pages

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

Video | 15 minutes

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

White Paper | 16 pages

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

Video | 4 minutes

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.watch now

Video | 7 min

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.view all

Service Overview | Varies

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.view all

Market Data | 1 page

Read by 50,000+ device professionals worldwide. Stay updated on changes to global medical device regulations.view all

 

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

Device Regulation | Downloadable PDFs

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

Market Data | 1 page

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

Process Chart | Interactive Page