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KGMP Regulation Amendment









From July 01st 2019, an amended KGMP regulation will take effect.

The major changes are as follows:


1. KGMP reference standard will be changed from ISO 13485:2003 to ISO 13485:2016.


2. The cases for a document audit are reduced to the four as follows:

1) When a new KGMP category is to be added on the existing KGMP certificate

2) When the manufacturing site’s address was changed

3) For a first KGMP certification, when another Korean company holds a valid KGMP certificate to the manufacturing site

4) When a device license holder holds multiple KGMP certificates to be renewed, only one manufacturing site – who is manufacturing the highest class product and sold the greatest volume in Korea – is selected for an on-site audit, and the other sites are for document audits.


[Deleted item] When a legal manufacturer employees two or more contracting manufacturers for outsourced manufacturing, an on-site audit shall be conducted to one contract manufacturing site and the other sites shall be subject to document audits.

Because of the deleted item, when a legal manufacturer works with multiple contracting manufacturers, the multiple contracting manufacturers will be subject to an on-site audit to each site.


[Also, in the event where an on-site audit to a manufacturing site is not possible due to war, infectious diseases, natural disasters and etc., an on-site audit is temporarily postponed and a document audit is conducted.]


3. Additional documents to be submitted on making an application for KGMP certification - Organization chart

- A document log listing the quality documents (document name and revision information must be identifiable)

- Quality control summary (The MFDS is working on the format. A guidance is scheduled to be announced before July 01st 2019.)

- Declaration of Conformity (The MFDS is working on the format. A guidance is scheduled to be announced before July 01st 2019.)

- Summary of Validation of the Processes for Providing Production and Services in regards to the product for KGMP certification

- Summary of Control of Monitoring and Measuring Equipment in regards to the product for KGMP certification

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