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[Press Release, July 31, 2020] MFDS Publishes English Version of Medical Product Approval Reports
  • Registration Date 2020-07-31
  • Hit 139
[Press Release, July 31, 2020 / unofficial translation]


MFDS Publishes English Version of Medical Product Approval Reports
- Driving the Export of K-brand is Expected by sharing Current Trends in Medical Products Approval in Korea -


□ The Ministry of Food and Drug Safety (MFDS; Minister: Lee Eui-Kyung) has prepared and published the English version of the “2019 Drug Approval Report” and “2019 Medical Device Approval Report” to introduce the current trends of medical product approvals in Korea to the overseas.

○ Korea has recently earned a higher level of global recognition for “K-quarantine system”; and the country’s role in international organizations such as IMDRF* has expanded.
- Against this backdrop, foreign regulatory authorities and companies have expressed a tremendous interest in Korea’s bio-health industries and system, etc..
* International Medical Device Regulatory Forum (IMDRF) is a consultative body established for the international harmonization of medical device regulation and consists of 10 member states: the US, the EU, Japan, Australia, Canada, China, Russia, Brazil, Singapore, and South Korea.

○ Both approval reports are published and distributed annually with a purpose to actively respond to the global demands and provide the current approval status of domestic medical products to the overseas in a transparent manner.


□ The main contents of each report for drugs and medical devices include ▲ general information of product approvals and notifications ▲ approval, certification, and notification by product category ▲ approval of new drugs, orphan drugs, and high-tech medical devices.

○ The English version of the “2019 Drug & Medical Device Approval Reports” will be available at the MFDS Official English website to ensure foreign regulatory authorities and companies a direct access to the reports.


□ The MFDS will continue its effort to share current approval information of Korean medical products with the world through swift information disclosure, and also actively support the expansion of Korean bio-health industries in the global market.


※ Online Distribution of Approval Reports
【 2019 Drug Approval Report】
- MFDS English website (www.mfds.go.kr/eng) > Our Works > Drugs > Products? MFDS Korean website (www.mfds.go.kr) > 법령/자료 > 자료실 > 매뉴얼/지침

【2019 Medical Device Approval Report】
- MFDS English website (www.mfds.go.kr/eng) > Our Works > Medical Devices > Products? MFDS Korean website (www.mfds.go.kr) > 법령/자료 > 자료실 > 매뉴얼/지침
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