The new KGMP is in effect today!

Changes are happening…

Starting today, companies applying for a new or renewal of Korea Good Manufacturing Practice (KGMP) certification will be subject to a few new requirements.

The Korean Ministry of Food and Drug Safety (MFDS) announced changes made, given harmonisation of KGMP requirements to the latest ISO 13485:2016. Stating the rationale behind these changes, MFDS shared that “harmonising KGMP requirements with the latest edition of ISO 13485 would improve quality control and establish more rigorous criteria for desktop audits for quality system compliance.”

As Class II, III, and IV medical devices would require the KGMP certification in order to be placed on the South Korean market, it is clear that the importance of patient safety is taken seriously by the authorities.


But no need to worry!

We see how such requirements can help ensure quality control of medium- and high-risk medical devices, and look forward to continuous development in South Korea’s medical industry.

Should you be affected by this change, don’t worry. Stendard can help you adjust to these changes!

With our bilingual platform and Meditip, our consulting partner in Korea, you can be equipped to stay compliant and fulfill requirements as outlined by MFDS.