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 우리나라 의료기기 제도 영문 홍보물

-Your Vision, Our Future-Korean Medical Device

[목차]

01. Passion for Growth Excellence
02. Internationally Aligned Medical Device Regulatory System
03. Strategic Operation based on Expertise & Efficacy
04. Special New Acts on Innovative Medical Devices and IVDs
05. Predictable Approval System with Scientific Approach
06. Emphasis on Quality: QMS
07. Adverse Event Reporting
08. Monitoring & Tracking System
09. Recalls
10. Research Development Project Aimed at Advancing Medical Device
11. Sustainable Effort & Committment for International Cooperation

[내용]

01. Passion for Growth Excellence

- Korea’s medical device market ranks as the ninth largest in the world at an estimated 6.8 billion USD in 2018, showing continuous grow with 8.1% annual increase.

- As producers of world class technology, Korean medical device manufactures are attempting to export to the global medical devices market whose safety and effectiveness have been proven by Ministry of Food and Drug Safety (MFDS).

- Korea has become a clinical trial powerhouse for various innovative medical devices with the accelerated clinical trial approval system and ISO 14155 compliance.

- There are a total of 166 clinical trial centers designated by MFDS, providing diverse and robust environments for clinical trials.

02. Internationally Aligned Medical Device Regulatory System

- Korean regulatory systems, harmonized with the global regulations, allow MFDS to manage the medical devices more effectively.

- MFDS has an efficient and well-balanced system to manage the overall lifecycle of medical devices

...................(계속)

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