Korean Medical Device Regulations.
BCG supports medical device and
IVD companies entering Korea, Europe and the United States.
Medical Device Registration in Korea
To sell medical devices in Korea, the applicable requirements for the three elements below must be met.
Manufacturing & Import Business Licences
This licence applies to medical device manufacturers and importers. Applicants must appoint a quality manager who meets the qualification requirements of Article 11 of the Enforcement Rule of the Medical Devices Act.
KGMP Certification
The manufacturer's and manufacturing sponsor's quality management systems are assessed through an on-site audit or document review. MDSAP certification may allow the initial assessment to be conducted by document review.
Product Registration
Depending on device classification, the procedure is notification, certification or approval. The safety and performance of the device to be manufactured or imported are evaluated.