Utilize MDSAP certificate for KGMP certification
An MDSAP certificate obtained through a physical audit to the site can be used for KGMP certification if the following conditions are...
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NEWS & UPDATE
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8월 9일
Unified process for Class 1 devices
As of August 07, 2024, the Medical Device Act has been amended to unify the registration pathway for Class 1 devices into a universal...
2022년 8월 12일
Medical Device Liability Insurance Policy
The MFDS regulation was amended to add the new requirement for medical industry to purchase medical device liability insurance policy and...
2020년 7월 3일
Mandatory Reporting the Medical Device Supply Records: Took effect on July 01, 2020
The Ministry of Food and Drug Safety (MFDS) started putting into action of the law of 'Mandatory Reporting of the Medical Device Supply...
2020년 3월 20일
Korea Device License Renewal every 5 Years
Recently the Korean government has passed an amendment bill that would force the Korea License Holder (KLH) to renew all their Medical...
2019년 4월 12일
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...
2017년 12월 8일
UDI plan in Korea
A draft amendment to the Korea Medical Device Act was announced on November 30th that includes operating “A Management System for...
2017년 11월 28일
How medical devices are reimbursed in Korea?
Korean Ministry of Health and Welfare (MoHW) operates national health insurance (NHI) system of which major revenue is from the Korean...
2017년 11월 28일
What is KGMP?
KGMP(Korea Good Manufacturing Practice) is almost identical to ISO13485 except that Korea health authorities look at the aspects required...
2017년 11월 28일
Do you know how many medical device categories exisit in Korea?
In Korea medical devices are classified under over 2,000 categories set by MFDS (Ministry of Food and Drug Safety). These 2,000...
2017년 11월 28일
What should consider before launching a medical device in Korea?
The first thing would be to check “if a similar product has been in the Korea market” and “if the medical procedure wherein the medical...
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