Regulatory Pathway: Define Your Device's Future in 4 Weeks.
Ambiguity is the Enemy of Time to Market.
Entering the MFDS approval process without a clear pathway leads to rejected applications and squandered capital.
Medical Device Determination Report
A clear, legally-sound analysis confirming whether your product falls under the MFDS definition of a medical device, avoiding unnecessary regulatory burdens.
Device Classification & Product Code Report
Identification of your exact product code and risk class (I-IV), setting the foundation for your entire regulatory submission strategy.
Clinical Trial Necessity Assessment
An evidence-based evaluation determining if your existing data is sufficient or if local clinical trials are mandatory for MFDS approval.
Comprehensive Regulatory Pathway Roadmap
A definitive action plan outlining the required documents, testing, estimated costs, and exact timelines from preparation to final clearance.
Proven Clarity Across Modalities.
AI Diagnostic Software Pathway
Successfully determined the clinical trial exemption strategy for a novel AI device, cutting the launch timeline by 12 months.
Wellness vs. Medical Device
Reclassified an aesthetic light-therapy device, saving the client from rigorous Class II testing requirements.
Class III Implant Classification
Established a definitive predicate device comparison strategy, avoiding a costly De Novo pathway.
Eliminate Regulatory Risks Today.
Don't write another line of your technical file until you are 100% certain of your pathway.
Request Your Pathway ConsultationFrequently Asked Questions
Common queries about regulatory pathways.