Medical devices are classified into 4 classes
(Class I-IV) based on potential risk factors to
human health.

Products are required to be submitted to MFDS
for approval as follows:

Types of data required to be submitted for
review of technical documents are as follows:
Identify the performance and safety of the
products which are related to the test
specification, grounds for establishment, and actual measurements.
Test specification is established by the party who is to receive the review of technical document in order to identify the performance and safety of
the product.

GoodManufacturing Practice
Assess the production of medical devices and
suitability of the quality control standard in
accordance with the Medical Device Act.

Apply Korea Quality System Regulation for
Medical Devices equivalent to ISO 13485:2006.
(Medical Device Affairs Enforcement Regulations Annex 3)

Site Audit (4days)
Document Audit

Upon completion of the MFDS review,
certification will be issued and product can now be sold in KOREA