Korea Medical Device Certification: Faster Process for Class II Medical Devices
On September 14, 2026, the Ministry
of Food and Drug Safety (MFDS) announced a proposed partial amendment to the
Enforcement Rule of the Medical Devices Act to establish a one-stop procedure
that links certification with technical document review, with the aim of
supporting faster market entry for Class II medical devices with relatively low
potential risks.
Public comments on the proposed
amendment will be accepted until October 26, 2026.
Previously, to obtain certification
for a Class II medical device, applicants had to follow a two-step sequential
process: first, complete the technical document review by a designated
technical document review institution, and then apply for certification to the
National Institute of Medical Device Safety Information (NIDS) by submitting
the review report.
Once the proposed amendment takes
effect, companies will be able to apply to NIDS for Class II medical device
certification and technical document review at the same time.
As a result, the time required for
certification and review is expected to be reduced from approximately 40 days
to approximately 25 days.
Meanwhile, the MFDS plans to
continue operating the existing sequential process as well, allowing companies
to choose the procedure that best suits their product and certification
schedule.
Through this regulatory
improvement, the certification process for Class II medical devices is expected
to become more streamlined and the processing time shortened, reducing the time
required to enter the Korean medical device market.
Frequently Asked Questions (FAQ)
Q. What types of products are
classified as Class II medical devices?
Class II medical devices are devices with relatively low potential risk.
Typical examples include thermometers, blood pressure monitors, dental scalers,
and contact lenses.
The medical device category and
classification for each product can be found in the Regulation
on Medical Device Categories and Classifications by Category.
Q. Are all Class II medical devices
subject to certification?
Depending on the product category, Class II medical devices may be subject to
either certification or approval. Therefore, the exact product classification
and applicable regulatory procedure should be confirmed in advance.
How GCA KOREA Can Help
GCA KOREA supports global manufacturers and importers with:
CONTACT ⬇
Tel: +82-31-360-8180
E-mail: forest.lee@gca-kr.com
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