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SOUTH KOREA MEDICAL DEVICE REGISTRATION
Medical device products registration in South Korea is 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 formatting is similar 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.
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 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|
|Medical Device Information & Technology Assistance Center|
|Class II with S.E.||25 days||US$112|
|Third Party Reviewer|
|Class III and IV with S.E.||65 days||US$617|
|Ministry of Food and Drug Safety (MFDS)|
|Class II, III, and IV without S.E.||80 days||US$1,283|
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.
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.
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|
|Re-registration||All||US$1,200/application||20 working days||1~2 month|
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 fast and efficient South Korea device registration by an experienced local regulatory professional.
South Korea Regulatory Support
US: +1 512 898-9222
Latest Market Updates
- South Korea Releases Guidance for Software using Big Data, AI, and Machine LearningSeptember 18, 2020 - 5:40 pm
- MEDICAL DEVICES SHIPMENTS DURING THE COVID-19 PANDEMICJune 4, 2020 - 8:28 pm
- GUIDANCE ISSUED FOR IMPORTING UNREGISTERED MEDICAL DEVICES INTO KOREAMarch 16, 2020 - 8:28 pm
- 4 PRODUCT DEVELOPMENT DECISIONS THAT IMPACT SALES PERFORMANCE IN ASIAOctober 2, 2019 - 6:51 pm
- KOREA CHANGES MEDICAL DEVICE QUALITY SYSTEM REQUIREMENTSApril 20, 2019 - 10:47 pm