MFDS Launches GMP Support for Korean Medical Device Firms

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Korea’s Ministry of Food and Drug Safety (MFDS) has introduced a new technical support program to strengthen the quality management systems of domestic medical device manufacturers through the adoption of international Good Manufacturing Practice (GMP) standards.


The program, in collaboration with the Daegu Gyeongbuk Advanced Medical Industry Promotion Foundation and the Korea Smart Healthcare Association, targets companies seeking new manufacturing licenses or aiming to meet international GMP standards for export.


To assist the target companies, the program includes:

  • Over 160 sessions of customized technical support
  • Over 4 training sessions on international certification
  • Over 10 hands-on quality management workshops, organized by level

In addition, MFDS is developing a guideline featuring case examples of usability evaluations to improve the ease of use and safety of medical devices. The program is expected to provide practical support for companies preparing to adopt international GMP standards, with continued efforts to help establish strong quality systems in Korea’s medical device industry.


From GMP readiness to KC Certification — GCA KOREA supports your medical device every step of the way.


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👉 Contact GCA

Tel. +82-31-360-8180
Email: forest.lee@gca-kr.com

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