Medical Device Registration 

One or two Korea predicate devices must be compared with the product for Korea registration to determine a regulatory pathway (SE or non-SE).

Indications for Use, Mode of Action, Raw Materials and IFU are the major aspects to be compared.

When it is determined that the device is not substantially equivalent, a non-SE path must be processed.

In case where a new medical procedure/intervention should be introduced during the device application, nHTA (new health technology assessment) review should be followed. One stop nHTA review is implemented as part of a non-SE path.

KGMP (Korea Good Manufacturing Practice) Certification

From year 2016, a KGMP certificate to “KLH/manufacturer/ KGMP category” must be submitted during a device registration process. Once a KGMP certificate is obtained, that must be renewed every three (3) years.
 

HIRA Reimbursement Coding

A HIRA process is required to obtain an EDI code when the product is used in hospitals as a consumable product. Legal timeframe is 100 working days.

Korea License Holding Service

This is to provide in-Korea legal representation services for an overseas medical device manufacturer, which can be an economic way to control over a medical device license when an overseas device manufacturer does not have an office in Korea.

Medical Device Determination

It is not always clear if a product falls under a medical device category in Korea and/or what is an applicable medical device category.

In this case, we make an application to the MFDS with submitting the documents meeting the MFDS requirements to obtain a legal decision on the applicable device category.

Legal time frame is 10 working days and no official fee is incurred.

[Note]

- MFDS: Ministry of Food and Drug Safe 

            Reviews/approves Class III/IV medical devices

- NIDS: National Institute of Medical Device Safety Information

            Reviews/approves Class I/II device

- HIRA: Health Insurance Review & Assessment

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