MEDIGUIDE

REGISTRATION FOR FOREIGN MANUFACTURER

The official name of Korean Competent Authority is MFDS (Ministry of Food & Drug Safety), but most people are calling it with old name, KFDA (Korea Food & Drug Agency), because it is more easy to understand.

The registration procedure differs according to class of the device. KFDA is running 4 step classification system (class 1 to 4), and each product has its predesignated class, like that of US FDA. Every application document shall be prepared in Korean Language and be submitted by registered importer.

In addition to product registration, you need designate registered importer in Korea and have to get KGMP certification.

In Korea, registration holder is importer, not foreign manufacturer. For the foreign manufacturer who want to be registration holder, our company supplies contract registration holder service. For the more information, see the chapter [Registration Holder Service]

Following table shows summary of the procedure.

CLASS 3,4 CLASS 2 CLASS 1 KGMP

*The summary of the permit system for each level is as follows.

Registration procedure consists of 2 steps, review of TCF and approval. The approval steps is just administrative steps which finalizes the registration process. In case of class 3 and class 4 product, you can apply 2 steps at once.

TCF shall be prepared in Korean language, and include many of technical information like, indication, instruction for use, raw material, function, etc. The evidences supporting the information shall be submitted together. In case of supporting materials, the documents written in English is applicable. The inspection is performed in National Institute of Safety Evaluation for the 55 working days. Auditor can ask more information and/or supporting material during inspection.

In case of newly applied device in Korea, the more information about operational principle and clinical efficacy and safety is necessary. When necessary, clinical investigation can be required.

In addition to above registration process, you need to get KGMP certificate before application of approval.

The registration procedure consists of 2 steps, review of TCF and approval as the registration procedure of class 3 and 4 device.

But in usual case, the TCF shall be prepared in different application form which is focused on substantial equivalence comparison with predicate device. Inspection will be performed in predesignated 3rd party reviewing agent, which is similar to NB for CE marking procedure or 3rd party reviewer for US FDA approval. Usually, this process is a little convenient than TCF review by KFDA.

When KFDA staff judge your device as new device, you have to undergo TCF review procedure which is same to that of class 3, 4 device.

Getting KGMP certificate is also necessary for all class 2 device.

You can make Korean AR apply registration to Medical Device Data Supporting Center, without undergoing TCF review process.

You don’t need to get certificate of KGMP either unless you have another class 2 device or more.

In addition to registration of product, you have to get certificate of GMP system called as other countries like EU, US, etc.

The contents of KGMP is substantially same to those of ISO 13485. Therefore, if you have GMP system in accordance with ISO 13485, you don’t need setup of new system or total revision. You can get certificate of KGMP with just a little modification and/or supplementation on existing system.

The audit may include on-site audit. If it is first registration to KFDA, you have to prepare for the audit.

We supplies consulting service related to KGMP certification as well as product registration.