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INTER MD INC.

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...

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INTER MD INC.

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...

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INTER MD INC.

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...

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INTER MD INC.

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...

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INTER MD INC.

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...

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INTER MD INC.

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...

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INTER MD INC.

What is KGMP?

KGMP(Korea Good Manufacturing Practice) is almost identical to ISO13485 except that Korea health authorities look at the aspects required...

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INTER MD INC.

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...

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INTER MD INC.

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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