GGuidelines
Medical device regulatory guidelines.
Korean approval, certification, and notification procedures — with the governing rules, standards, and submission documents — organized for practice.
By device type2026.07.08Ultrasonic Inhaler Approval Guide for Korea'Ultrasonic inhaler' is a name shared by home nebulizers and surgical aspirators. Which one you have completely changes the class, tests, and timeline.
By device type2026.07.08Rehabilitation Robot Medical Device Approval Guide for KoreaMechanics, electronics, software, and clinical evidence converge in rehabilitation robots. Classification, the clinical-data variable, and what to prepare at each development stage.
By procedure2026.07.08Complete Guide to Korean Medical Device Approval — Notification vs. Certification vs. ApprovalIs your product a notification, certification, or approval? Classification criteria plus a one-page comparison of procedures, timelines, and key documents for all 4 classes.
By device type2026.07.08Nebulizer Approval Guide for KoreaCompressor, ultrasonic, and mesh nebulizers — classification, review points, accessory configuration for imports, and KGMP: the practical checkpoints for inhalation therapy devices.
GMP2026.07.08KGMP Conformity Assessment Guide — Audit Types, Required Documents, Overseas Site PreparationKGMP, the rite of passage for Class 2+ devices in Korea. Audit types, the quality system document framework, and the real reasons overseas site audits delay projects.
Import & customs2026.07.08Medical Device Import Guide for Korea — From Import Licensing to Customs ClearanceThe full process of bringing overseas medical devices into Korea — import business notification, product licensing, customs requirements, and the 3 reasons shipments get stuck at port.
By class2026.07.08Class 2 Medical Device Certification Guide for KoreaThe correct term for Class 2 is 'certification.' Technical file review, testing, and KGMP first appear here — the 5-step process and the 3 variables that drive the timeline.
By class2026.07.08Class 1 Medical Device Notification Guide for KoreaClass 1 devices proceed by 'notification' with no review. The 4-step process, required documents, and the 3 most common rejection points.
By procedure2026.07.08Medical Device Cybersecurity Guideline for Regulatory ReviewKey cybersecurity review guidelines selected by CLARE Partners for preparing submission dossiers for connected medical devices in Korea.
Just send the product details.
We do the reviewing.
We pre-review device class, required pathway, and data readiness free of charge, and reply within 1 business day. No sign-up.