Medical Device Registration 

Before proceeding a medical device in Korea, one predicate device registered in Korea must be selected and compared in perspectives of "Indications for Use", "Mode of Action", "Raw Materials composition/ratio" and "IFU" between the products. Through this process, the regulatory pathway (SE or NSE) to follow is determined.

In case where a new medical procedure/intervention (that is determined by HIRA) is introduced during the device application procedure, nHTA review by NECA should be followed, and one-stop nHTA review can be processed while a NSE path is processed by the MFDS.

[Legal Timeframe]

SE Path

  Class 1           : 5 working days

  Class 2           : "25 working days by 3rd party" + "5 working days by NIDS"

  Class 3 and 4  : 65 working days

NSE Path        : 80 working days (universally applied to all classes) 

A device license is issued with a 5-year valid period, and an application to renew the device license must be submitted to the MFDS or NIDS before 180 days (6 months) from the expiration date. 

KGMP (Korea Good Manufacturing Practice) Certification

From year 2016, a KGMP certificate issued to “KLH/ manufacturer/ KGMP category (these three are coupled for certification)” must be submitted during a device registration process. To maintain the device license effective, the KGMP certificate must be renewed every three (3) years with making an applicatioin before 3 months from the expiration date.

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 overseas medical device manufacturers, which can be an economic way to control over the device licenses/ certificates when the overseas manufacturers do not have their own offices in Korea.

Medical Device Determination

In some cases it is not clear to know whether a product falls under a medical device category defined by the MFDS or locate a suitable category.

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

Legal time frame for this process is 10 working days.

[Abbreviations]

- MFDS : Ministry of Food and Drug Safety

             Reviews/approves Class 3/4 medical devices, NSE devices

- NIDS : National Institute of Medical Device Safety Information

             Reviews/approves Class 1/2 devices

- HIRA : Health Insurance Review & Assessment

- NECA : National Evidence-based Healthcare Collaborating Agency (nHTA process)

- nHTA : new Health Technology Assessment 

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