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KGMP (Korean GMP requirements) vs. ISO 13485

J

johnq98

#1
It is said that the Korean GMP requirements are similar to ISO 13485 but my search for a comparison between Korea's standard and ISO 13485 is no where to be found. Can someone direct me to any source for that information.
 

sreenu927

Quite Involved in Discussions
#3
See attached checklist for KGMP audit.

The audit will be for 4-5days; depending upon the device classification and size of the site and QMS complexity, the # of auditors could be 1-3 including a 3rd party and MFDS auditors. If class 2, only a 3rd party auditor will inspect the facility.
Take note that all costs are to be borne by the Korean Importer as per the MFDS regulations, but it depends on the agreement between Korean Importer and Foreign Manufacturer.

Hope this helps!

Regards,
Sreenu
 

Attachments

J

johnq98

#5
Regarding the checklist, where can I find the stated "Article 7 of Standards for Manufacture, Import and Quality Management of Medical Device".
 
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