KFDA - KOREA MEDICAL DEVICES REGULATIONS
Dealing with the Korean regulatory structure can be tricky and requires
expertise on the ground. Communication and consultation with officials
is necessary at many stages. However, these are not reasons to stay away—but reasons to
be deliberate and patient in entering this key Asian market.
Under Korean laws, a foreign manufacturer without a Korean office may
not directly submit a device registration application to the KFDA, but
the company may allow its importer to do the registrations. The
manufacturer also may hire an independent third party based in Korea to
make the registrations in its own name.
In addition, Korea does not allow devices into the country if they have
not been approved in their country of manufacture. A Certificate to
Foreign Government or Free Sale Certificate is an integral part of a
foreign product’s application.
Three processes are required to get a device registered in Korea: a
product license; Korean Good Manufacturing Practice (KGMP)
certification; and a Device Business License. Of these, the KGMP
certification must be renewed every three years. The other two are valid
permanently, although changes may require re-registration.
Devices are divided into four classes, with Class I being lowest risk
and Class IV being highest risk. A strict system of more than 1,000
classifications segments devices into those four classes; however, there
are plans to expand the number of classifications in the near future.
Product License: Class I
The procedure for Class I devices is relatively simple: only
notification is required, not approval. The applicant simply submits a
standard notification to a KFDA District Office. This notification
includes information on the product, its manufacturer or importer, its
classification, purpose of use, instructions for use, raw materials and
specifications, dimensional drawings, precautions and the labeling to be
used. Once it is submitted, the District Office will issue an
acceptance letter, which is equivalent to a product license in this
Product License: Classes II-IV
Classes II, III and IV devices need to go through a full review and
approval process. Approval in the country of origin can speed up the
process somewhat but is not sufficient in itself for product
registration in Korea. On the other hand, some progress in efficiency
has been made by the admission of third-party review organizations into
the process. The two main requirements for a product license are a
technical file and type testing.
The first requirement for a product license is the submission of a
technical file, which falls into two categories: the general technical
file and the safety and effectiveness review (SER) technical file.
The general technical file’s requirements are broadly similar to that of
a 510(k) submission in the United States. It is used when a similar
device already has been approved. There is a one-page application form
that contains much of the same material as in the notification form for
Class I devices but requires additional attachments detailing further
information. These attachments include information on physical and
chemical characteristics, electrical safety and performance, among
others—all supported by test reports. The SER technical file is required for more novel devices. Besides the
general file requirements, it includes information on the development
process, stability reports and comparative analysis with other devices.
In addition, it requires clinical study reports.
The KFDA does accept foreign clinical trials for approval—not
necessarily needing local ones—but there are criteria for consideration
of these trials. They must be published in a prominent medical journal
(the Science Citation Index is one arbiter of prominence), or else they
must have been accepted by the government of the country of manufacture
for its own approval procedure. In the latter case, documentation of
that acceptance in the foreign country should be attached.
Clinical trials are only required as a rule for SER technical files, but
the KFDA also may require them at its discretion for general technical
The technical file must be reviewed and approved. If it is a Class II or
III product and does not require an SER file, a third-party
organization can do this. A review by the KFDA takes two to three
months. Reviews by third-party organizations, in contrast, take only
about one month, although they cost more (about $350 compared to $30-$40
for the KFDA).
Besides the technical file, the other requirement for a product license
is type testing. Only third-party labs do this, not the KFDA. It
requires submission of samples and the technical file.
Applying for a Product License
Once both technical file review and type testing are complete, the
technical file (with approval) and certificate of compliance must be
submitted to the KFDA. Attached should be a list of the applicant’s
facilities in Korea and (for foreign devices) a free sale certificate
from the device’s country of manufacture. After reviewing all of these,
the KFDA will issue a Product License, which does not expire.
Device Business License
This license, similar to the US Certificate of Device Establishment, can
be obtained by submitting one Product License and other information on
the company (facilities, business registration and health certificate
for its representative). It does not expire. Of course, an importer
typically would have such a license already for other products.
A company applies for KGMP certification by way of a third-party
inspection organization. This organization does not do the entire
inspection but assists the KFDA inspectors in much of their work.
In the case of foreign manufacturers without an office in Korea, only
the importer undergoes inspection, but it needs documentation from
foreign manufacturers to demonstrate its compliance. Some token
manufacturing or importing must be done to produce a paper trail
demonstrating compliance, even if the device cannot be sold yet.
Once these three licenses have been obtained—Product License, Device
Business License and KGMP Certification—it is finally legal to market a
medical device in Korea. Beyond regulatory permission, there are other
important processes as well, such as obtaining reimbursement from
Korea’s national health insurance system, as well as post-market