Medical Device Registration 

Before starting a medical device registration project in Korea, it is necessary to select a specific predicate device that is already registered in Korea for comparison. This comparison involves evaluating factors such as indications for use, mode of action, raw materials composition and ratio, instructions for use, and performance between the two products. Based on the outcome of this comparison, the appropriate regulatory pathway (SE or NSE) is determined for the device registration.

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If a new medical procedure or intervention that is determined by the Health Insurance Review and Assessment Service (HIRA) is introduced during the medical device application procedure, a review by the National Evidence-based Healthcare Collaborating Agency (NECA) may be necessary. In such cases, a one-stop nHTA (new health technology assessment) review can be processed while a NSE path is being processed by the Ministry of Food and Drug Safety (MFDS)."

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Legal Timeframe

SE (Substantially Equivalent) 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 (Not Substantially Equivalent) Path       

• 80 working days (universally applied to all classes) 

A license for a medical device is valid for a period of 5 years. If the license is due to expire, the applicant must submit a renewal application to either the Ministry of Food and Drug Safety (MFDS) or the National Institute of Medical Device Safety Information (NIDS) no later than 180 days (6 months) prior to the expiration date.

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KGMP (Korea Good Manufacturing Practice) Certification

As part of the medical device registration process, a KGMP (Korean Good Manufacturing Practice) certificate issued to the KLH/manufacturer/KGMP category must be submitted. To ensure the device license remains effective, the KGMP certificate must be renewed every three years by submitting an application no later than 3 months prior to 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. Normal legal timeframe is 100 working days.

But in cases where an in-depth review is required, the review time can be prolonged beyond the expected timeline. 

It is very important to forecast how the product can be reimbursed by the Korea nataional health insurance system in prior to proceeding a registration project.

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Korea License Holding Service

Our in-Korea legal representation services for overseas medical device manufacturers can be an economical way to maintain control over device licenses/certificates when the manufacturers do not have their own offices in Korea.

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Medical Device Determination

If it is unclear whether a product falls under a medical device category defined by the MFDS or if a suitable category cannot be located, an application can be made to the MFDS with the required documents to obtain a legal decision on the applicable device category. The 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 : new Health Technology Assessment