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Medical Device Licensing
Reconciling safety with market reality
Manufacturing development and import licensing for medical supplies, equipment, and IVDs — covering KGMP, GIP, GSP, reassessment, renewal, KC certification, and overseas approvals in one place.
What we offer
Medical Device Licensing
Manufacturing · Import
Manufacturing development and import licensing for medical supplies and equipment. Technical document review and safety/efficacy review items.
Clinical Trials · Renewal
Exploratory and confirmatory clinical trial plan approval, medical device renewal, and device reassessment.
KGMP Consulting
Domestic KGMP. Manufacturing development GMP (medical supplies / equipment / IVD). Imported product GMP consulting.
GIP · GSP · Quality
Medical device Good Importing Practices (GIP), Good Supply Practices (GSP), annual quality management.
IVDs (In Vitro Diagnostics)
Licensing, GMP, performance evaluation, and clinical data consulting under the IVD Act.
KC · Overseas Certification
KC certification (electrical safety, EMC) and overseas certification strategy and registration support for CE, FDA, NMPA, and more.
Regulatory Process
Classification-tailored medical device consulting
Classification
Device class (1/2/3/4) determination, regulatory track, and review item assignment.
Technical · Clinical
Technical documentation, safety/efficacy data, exploratory and confirmatory clinical trial plan approval.
KGMP · Certification
Manufacturing/import KGMP, IVD GMP, and overseas certification (CE/FDA/NMPA) prepared in parallel.
MFDS Submission
Notification, certification, and licensing applications, deficiency response, and review negotiation.
Post-market
GIP/GSP, annual quality management, reassessment, and renewal — full lifecycle 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.