South Korea

May 2, 20241 min read

Philippines: South Korean MFDS as Reference Drug Regulatory Authority

On 29 April 2024, the Philippines FDA added Korea’s Ministry of Food and Drug Safety (MFDS) as its new Reference Drug Regulatory...

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Jun 28, 20191 min read

South Korea's MFDS Revision of Medical Device Manufacturing and Quality Control Standards

On 25 March 2019, South Korea's Ministry of Food and Drug Safety (MFDS) published a notification titled "Professional revision of medical...

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Jun 28, 20191 min read

Asia Reg News: AHWP Catch-up, Korea, Malaysia, Indonesia and Vietnam Updates

Executive Summary: Part 1 of this month's Asian Medtech Associations Regulatory Networking discussions features Asean medtech market...

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Nov 9, 20181 min read

Korea MFDS Plans for Harmonization with Latest ISO 13485 & MDSAP

Korea MFDS' entry into the International Medical Device Regulators Forum (IMDRF), together with their intention to harmonize with the...

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