KGMP (Korean GMP requirements) vs. ISO 13485

J

johnq98

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
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

  • KGMP Evaluation form+Checklist.pdf
    345.3 KB · Views: 1,474
J

johnq98

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

Clueless One

Climbing coporate ladders...by doing nothing.
Hi,
KGMP was changed from 13485:2003 to 13485:2016 compatibility, but there is no information in English available yet. All I have found is
의료기기 제조 및 품질관리기준 일부개정고시(안) 행정예고(식약처 공고 제2018-409호) 상세보기|입법/행정예고 | 식품의약품안전처

Does anyone know, until we can expect to get the Korea regulation requirements in English?

Nope, latest revision of KGMP is dated August, 2021 and the latest English version of KGMP is 2019, which is now totally invalid and dated version.
FYI, KGMP follows almost word to word from ISO 13485:2016 version so just following ISO can do you benefit.
 

Wolf.K

Quite Involved in Discussions
Nope, latest revision of KGMP is dated August, 2021 and the latest English version of KGMP is 2019, which is now totally invalid and dated version.
FYI, KGMP follows almost word to word from ISO 13485:2016 version so just following ISO can do you benefit.
Can you post the link to the 2021 version, please? I looked for it on the homepage, but I am a clueless one regarding Korean language, and on the English version of the homepage, nothing is written about a new version...
 

Clueless One

Climbing coporate ladders...by doing nothing.
Can you post the link to the 2021 version, please? I looked for it on the homepage, but I am a clueless one regarding Korean language, and on the English version of the homepage, nothing is written about a new version...

I'm afraid there are no English version of latest KGMP version or guideline. But they're older version of KGMP checklist which lacks ISO 13485: 2016 regulations such as updated CAPA checklist etc...

I attached the file so see for yourself.
 

Attachments

  • GMP 기준점검표 영문본(안)_한국의료기기산업협회.pdf
    391.7 KB · Views: 132
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