South Korea

Medical Device Registration in South Korea

Government Authority

Medical device regulations in South Korea are overseen by the Ministry of Food and Drug Safety (MFDS), formerly the Korea Food and Drug Administration (KFDA), under the Medical Device Act. Medical device registration in South Korea has a similar formatting to the European technical file/design dossier and 510(k) applications. Notably, all the application files must be submitted in the Korean language.

Medical Device Status

In Korea, instruments, machines, devices, materials and any similar products used alone or in combination for human beings or animals are considered medical devices.

Product Classification

Medical device classification closely follows the Global Harmonization Task Force (GHTF) Classification guidelines, with Class I, II, III and IV designations ranked from low to high risk categorization.

Registration Pathway

Registration review routes depend on the risk classification of the device and whether or not a registered predicate or Substantial Equivalent (S.E.) exists in Korea.

	Processing Time	Fees	Reviewing Body
Class I	0 days	US$73 (₩85,000)	Medical Device Information & Technology Assistance Center (MDITAC)
Class II with S.E.	25 days	US$112 (₩130,000)	Third Party Reviewer
Class III and IV with S.E.	65 days	US$617 (₩719,000)	Ministry of Food and Drug Safety (MFDS)
Class II, III, and IV without S.E.	80 days	US$1,283 (₩1,495,000)	MFDS

Class I devices are subject to a Pre-Market Notification (PMN). Applications are considered accepted upon submission. A PMN is issued on notification. Class III and Class IV with an S.E. are also subject to Pre-Market Approval (PMA). Class II, III and IV devices without an S.E. are subject to a Safety and Efficacy Review by the MFDS. There are 6 third party reviewers, 2 of which are international companies that also offer Notified Body/Registrar services.

Device Conformity Assessment

In addition to the administrative documents, technical documentation related to the quality of the medical devices is required for registration. The technical documentation consists of an application form and supplementary evidence. The presence of a mandatory submission of clinical trial reports (supplementary evidence) determines the application procedure. Technical documentation includes: Intended Use, Mechanism of action(MoA), Operational(Functional) Structure, Raw Materials, Instruction for Use, Test Specifications, and in some cases, clinical trial data.

Quality Systems Conformity Assessment

A Quality Systems Conformity Assessment is required for Class II, III and IV product manufacturers. Unlike many countries, where an ISO 1345 attests to Quality Systems Conformity, Korea requires a Korean Good Manufacturing Practices (KGMP) certification, to certify Quality Systems Conformity.

Find out more about the KGMP certification process.

Regulatory Efficiency

Korea is known for its highly sophisticated and efficient regulatory body and process.

Validity and Renewal

Medical device registration licenses do not expire, but the KGMP Certificate must be renewed every three years.

License Holder Requirements

A Licensed Local agent must submit the medical device registration application(s) and hold the license thereafter. In Korea, there is added benefit to using an Independent License Holder, because of the unique option for an identical product license registration. The MFDS allows expedited, identical license registrations with approval/attestation from the current License Holder.

License Transfer

As device license transfer involves taking over all legal responsibilities held by the previous KLH, the new KLH will takes over the KGMP certificate only with processing re-registration of identical device in lieu of transferring the device license(s).

Required document and Legal timeframe are as follows:

Required document

Timeline

Official fee

Consulting hours

KGMP certificate transfer

A notarized agreement in Korean language between the KLHs (a draft agreement will be provided)

– Preparing a notarized agreement: 2 weeks

– KGMP certificate transfer: 7 days

~100USD

Max 8 hours

Re-registration of identical product

A full copy of the device license in HWP format

A company letter attesting

1 month

~100USD/application

Max 6 hours per application

Re-registration of an Identical Product

In Korea, Independent License Holders are able to re-register identical licenses. This option allows License Holders to maximize the distribution channels. In order to pursue the re-registration pathway, the initial device registration must be processed by InterMD (an in-country representative for medical device registration).

InterMD service fees, timelines and a schematic diagram are as follows:

Item	Class	Service Fee	Legal timeframe	Practical timeframe
1st device registration	Standard Class 1	US$2,000	5 working days	1 week
	Standard Class 2	US$8,000	30 working days	3 months
	Standard Class 3	US$10,000	65 working days	5 months
	Standard Class 4	US$12,000	65 working days	5 months
Re-registration	All	US$1,200/application	20 working days	1~2 month

Clinical Trial

Korea has an accelerated clinical trial approval system and ISO 14155 compliance. There are currently 166 clinical trial centers designated by MFDS.

Benefits of Independent License Holding through Asia Actual

Sell directly to multiple regional distributors, avoiding mark-up by a national importer
Increase transfer pricing
Improve leverage in distributor negotiations/responses
Add or change distributors as required
Keep intellectual property away from local commercial agents
Assure expert handling of post market vigilance and license maintenance

Contact Asia Actual for assistance with your medical device registration in South Korea or to confirm the cost and time lines that apply to your specific devices of interest. Asia Actual has experienced, bi-lingual consultants in South Korea to manage the application, importing, and post-market surveillance needs.

Contact Us

US: +1 512 898-9222
SG: +65 3138-4148
EMAIL: Korea@asiaactual.com