Webinar: South Korea Overview Of The GMP Requirements with Stephen Jeong

In today's webinar, Priya Bhutani introduced the topic of Good Manufacturing Practices (GMP) requirements for South Korea. She provided an overview of Regdesk, a comprehensive regulatory solution that helps teams manage global technical files and stay updated on regulatory changes.

Priya emphasized the importance of audience participation during the Q&A session at the end of the meeting and encouraged attendees to submit their questions throughout the presentation.

Stephen Jong, a regulatory consultant, discussed the specifics of Korea's GMP requirements, which are crucial for the registration of medical devices in the country. He explained that Korea's GMP (kgmp) certification is essential for medical devices classified from Class II to IV and is necessary for pre-market approval.

Key Points:

Overview of Korea: South Korea is a significant market for medical devices, regulated by the Ministry of Food and Drug Safety (MFDS).

GMP Certification: This certification is mandatory for importing and releasing medical devices in Korea. It requires renewal every three years.

Key Definitions: The legal definition of manufacturers, especially the distinction between legal and physical manufacturers, was highlighted.

Application Process: The process for obtaining kgmp certification involves collaboration with notified bodies and the MFDS, including multiple audit stages.

Audit Types: Different types of audits (initial, additional, and change audits) were described, with details on the requirements for each type.

GMP Requirements: Stephen briefly mentioned that the requirements are largely based on ISO standards but include unique aspects for Korea.

The session concluded with an invitation for questions and feedback on future topics. Participants were assured that the PowerPoint presentation would be emailed to them afterward.