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Medical Device Licensing
From GMP to IVD, the full medical device landscape
Comprehensive consulting across Class I–IV medical devices, KGMP compliance, and in-vitro diagnostics.
What we offer
Medical Device Licensing
Device Licensing
Notification, certification, and approval for Class I–IV medical devices.
KGMP Compliance
Korean Good Manufacturing Practice compliance consulting.
In-vitro Diagnostics
IVD licensing and performance evaluation under the IVD Medical Device Act.
System Analysis
SaMD (Software as Medical Device) and AI medical device system verification.
Clinical Trials
IDE protocol design and clinical data management.
Post-market Safety
Adverse event reporting, advertising review, re-examination.
Regulatory Process
Tailored process by device class
Classification
Risk assessment and filing track (notification/certification/approval) determination.
Technical File
Performance evaluation, clinical trials, standards compliance dossier.
Conformity Review
MFDS or designated body (KTL, KTR) review response.
Market Entry
KGMP compliance, advertising clearance, distribution channel support.
If the first step feels difficult
The first decision in regulatory consulting matters most. Book a free 30-minute consultation with MEDISOL to design the most efficient market entry path together.