Hamburg, 24.05.2019, Juliane Celik

Important changes are introduced for all medium and high-risk medical devices with regards to QMS requirements, registration and inspection Korea Authority.
The Korean Ministry of Food and Drug Safety (MFDS) announced changes to the requirements for Korea Good Manufacturing Practice (KGMP) certification.
Any company applying for new or for renewal of KGMP certificates after July 1, 2019 will be subject to the following new requirements:

• KGMP reference standard will be changed from ISO 13485:2003 to ISO 13485:2016.
• On-site inspection of contract manufacturing sites will increase
• Additional documents will be made mandatory for KGMP application

Medical device manufacturers active or interested in the Korean market should be prepared for the changes. Do you have questions or concerns? Just contact us!