Korea’s Ministry of Food and Drug Safety (MFDS) recently published final revisions regarding importing non-registered medical devices under special circumstances, including for research and personal use only, scarce or urgently needed, to be used by a Korean laboratory, clinical trials and/or orphan products.
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 renewal 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
- While certification to the standard is not required, quality systems must demonstrate compliance to the same
- On-site inspection of contract manufacturing sites will increase
- The provision requiring only one contract manufacturer to be subject to an on-site inspection has been eliminated. Formerly, when a legal manufacturer employed two or more contracting manufacturers, an on-site auditing would be conducted to one contract manufacturing site and the other sites would only be subject to document audits. This change has the potential to add significant time and cost to the compliance requirements for manufacturers that employ multiple outsourced manufacturing facilities.
- Additional documents will be made mandatory for KGMP application
- Several documents have been added to the certification application aimed at closing the gap between paper audit and on-site audit requirements. The MFDS is expected to provide guidance on the format for items 5 and 6 before July 1, 2019. The additional documents are:
|2||Document log listing the quality documents |
(document name an revision information must be identifiable)
|3||Quality control summary|
|4||Declaration of conformity|
|5||Summary of Validation of Processes for Providing Production and |
Services related to the product for KGMP certification
|6||Summary of Control of Monitoring and Measuring Equipment |
related to the product for KGMP certification
Korea has a unique quality system assessment process for medical device manufacturers. Since April of 2012, KGMP certificates are a required element of Class 2, 3 and 4 medical device registration applications for foreign manufacturers. Certificates are product category, facility and license holder specific; and must be renewed every three years. Certificates are required for the legal manufacturing site as well as any contract manufacturing site involved with a critical manufacturing process.
Medical device manufacturers active or interested in the Korean market should be prepared for these changes.
Asia Actual has a strong regulatory team in Seoul to help device manufacturers stay informed and compliant with regulatory changes. Please contact us with questions or support requests.