Medical Device Pre-Market Approval Process in Korea
This course provides a comprehensive review of the Korean medical device pre-market approval process requirements released in April 2012. It will review the specific regulatory documents in place including the different market access programs, classification systems, device categories and Korean Good Manufacturing Practices. Learners will be walked through the decision process of which market access program is applicable to which kinds of medical devices and review exceptions to some rules. The course also includes review and inspection policies applied by the KFDA.
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Upon successful completion of this course, learners will be able to:
- apply the different requirements of the Korean regulations for medical devices
- understand the mechanism of categories and classifications of medical devices
- plan the Korean medical device listing or notification process for their devices.
Regulatory associates, regulatory managers, quality assurance managers, marketing and sales managers, and medical device manufacturer’s executives involved in bringing medical devices to the Korean market. Korean importers or license holders new to the Korean medical device system.
Understanding of the basic regulatory principles as outlined in IMDRF (former GHTF), including:
- Quality systems requirements as per ISO 13485
- Risk management as per ISO 14971
- IMDRF risk classification system basics.