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.

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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.

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[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

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

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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. 

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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.

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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.

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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.

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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.

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[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