The Digital Healthcare Device Act has been newly enacted in Korea, taking effect in February 2025. This new law applies to SaMD (Software...

An MDSAP certificate obtained through a physical audit to the site can be used for KGMP certification if the following conditions are...

As of August 07, 2024, the Medical Device Act has been amended to unify the registration pathway for Class 1 devices into a universal...

The MFDS regulation was amended to add the new requirement for medical industry to purchase medical device liability insurance policy and...

The Ministry of Food and Drug Safety (MFDS) started putting into action of the law of 'Mandatory Reporting of the Medical Device Supply...

Recently the Korean government has passed an amendment bill that would force the Korea License Holder (KLH) to renew all their Medical...

From July 01st 2019, an amended KGMP regulation will take effect. The major changes are as follows: 1. KGMP reference standard will be...

A draft amendment to the Korea Medical Device Act was announced on November 30th that includes operating “A Management System for...

Korean Ministry of Health and Welfare (MoHW) operates national health insurance (NHI) system of which major revenue is from the Korean...

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

In Korea medical devices are classified under over 2,000 categories set by MFDS (Ministry of Food and Drug Safety). These 2,000...

The first thing would be to check "whether a similar product is available in the Korea market” and “whether the medical procedure in...