Medical Device Development Support
From planning to regulatory approval — we support every step of medical device commercialization.
Dongsimwoo Bio provides specialized consulting and administrative support services throughout the entire lifecycle of medical device development, grounded in a deep understanding of the Korean Ministry of Food and Drug Safety (MFDS) regulatory framework. From new health technology assessment registration and regulatory approval procedures to clinical research design and IRB documentation — we navigate the complex regulatory environment to accelerate your medical device's market entry.
Regulatory Expertise
Development
Medical Device Development and Support System
Dongsimwoo Bio operates a full-lifecycle support system for the development of innovative medical devices spanning diagnostic and therapeutic domains. We internally execute all stages from planning and design to prototyping, performance evaluation, clinical trials, regulatory approval, and commercialization through our in-house research infrastructure. In particular, we aim to develop and bring to market next-generation smart diagnostic and therapeutic devices through the convergence of medical and traditional Korean medicine digital health technologies.
Commercialization Infrastructure and Practical Strategy Support
Comprehensive support through the medical device commercialization stage
1. Medical device certification support 2. New health technology registration support 3. Intellectual property protection (patent filing, technical specifications) 4. Technology transfer and joint commercialization
Diagnostic Medical Device Development and Support
In vitro diagnostics and smart diagnostic device development
1. Medical device regulatory review 2. Material compliance testing and electrical safety testing support 3. Patent filing and technical documentation support 4. GMP-based quality management system design consulting 5. Medical device clinical research design and institutional coordination support
Therapeutic Medical Device Development and Support
Digital health-based therapeutic device development
1. Non-clinical safety and efficacy testing design and analysis support 2. Medical device regulatory approval support 3. New health technology registration promotion support
Regulatory Framework
MFDS Medical Device Regulatory Framework
Medical devices in Republic of Korea are regulated by the Ministry of Food and Drug Safety (MFDS) and classified into 4 risk-based classes. Under the 'Immediate Market Entry for Medical Devices' system implemented in January 2026, 199 innovative medical device categories can now enter the market with MFDS approval alone, without a separate new health technology assessment.
Class 1 (Notification)
Medical devices with minimal potential risk
Medical devices such as medical forceps and manual wheelchairs with almost no potential risk to the human body. Sales are permitted through notification to the Korea Institute of Medical Device Safety Information only, with immediate processing without a separate technical document review.
Class 2 (Certification)
Medical devices with low potential risk
Medical devices with low potential risk, such as blood pressure monitors and X-ray devices. They undergo certification by the Korea Institute of Medical Device Safety Information, processed within approximately 30 days after technical document review. GMP compliance recognition is required as a prerequisite.
Class 3 (Approval)
Medical devices with moderate potential risk
Medical devices with moderate risk, such as artificial joints and dialysis machines. They require MFDS approval review, with technical document review taking approximately 65 days. When clinical trial data is included, it takes approximately 80 days.
Class 4 (Approval)
Medical devices with high risk
Medical devices with high potential risk to the human body, such as pacemakers and artificial heart valves. They undergo the most rigorous MFDS approval review, requiring comprehensive evidence of safety and efficacy along with clinical trial data.
Services
Core Support Services
We provide specialized services spanning the entire lifecycle of medical device development.
New Health Technology Assessment (nHTA) Registration Support
Expert support for NECA-based assessment procedures
We support the entire process of new health technology assessment conducted by the National Evidence-based Healthcare Collaborating Agency (NECA) under the Ministry of Health and Welfare. We develop strategies for smooth registration within the assessment period (250 days for medical procedures, 140 days for in vitro diagnostics), covering application preparation, safety and efficacy evidence preparation, systematic review execution, and subcommittee/full committee review responses. We also review applicability of the immediate market entry system implemented in 2026 (113 digital medical device categories, 83 in vitro diagnostic reagent categories, 3 medical robot categories).
Medical Device Regulatory Approval Administrative Support
Full-process administrative agency and consulting for MFDS approval
We support the entire MFDS regulatory approval process from product classification and class determination to technical document preparation, GMP compliance recognition, eMEDI electronic application submission, technical document review response, and approval certificate issuance. We develop optimal regulatory strategies by class and respond promptly to supplemental requests during the review process. We also provide specialized consulting for AI and SaMD medical devices subject to the Digital Medical Products Act (effective 2025).
Medical Device Clinical Research and Trial Support
From clinical trial design to IRB approval and MFDS IND approval
We systematically support the entire medical device clinical trial process. We minimize the time to clinical trial initiation by processing in parallel: clinical trial protocol preparation, Investigator's Brochure (IB) preparation, MFDS IND approval application (approximately 30 business days), and IRB review responses. We design clinical research compliant with Korean Good Clinical Practice (KGCP) and ICH standards, and domestic clinical trial data can also be used for FDA and EMA submissions.
GMP Certification Support
ISO 13485-based quality management system establishment and audit response
We support the establishment of quality management systems for GMP (Good Manufacturing Practice) compliance recognition for medical devices. We provide continuous support from quality manual, procedure, and work instruction preparation, to selection of the optimal audit organization among the 6 GMP audit agencies (KTL, KTC, KTR, KCL, TUV SUD, TUV Rheinland), document and on-site audit responses, and triennial periodic audit management.
Documents
Documentation Support
We provide professional support for the preparation of various documents required throughout the medical device development and regulatory approval process.
IRB Review Documents
We prepare the complete document package required for IRB review, including research protocols for IRB submission, informed consent forms, personal information processing consent forms, safety management plans, and vulnerable subject protection measures.
Clinical Trial Documents
We prepare the complete set of clinical trial documents compliant with KGCP standards, including clinical trial protocols, Investigator's Brochure, Case Report Forms (CRF), safety reports, and clinical trial result reports.
Regulatory Approval Technical Documents
We prepare technical documents for submission through the Medical Device Electronic Civil Application System (eMEDI), including safety and efficacy evidence materials, test reports, technical document review materials, product classification applications, and approval/certification/notification applications for MFDS submission.
GMP Quality Management Documents
We establish the complete quality management system documentation for GMP audits, including quality manuals, standard operating procedures (SOP), work instructions, quality management standards conformity assessment materials, and manufacturing/import business-related submission documents.
New Health Technology Assessment Materials
We prepare documentation required for the NECA assessment process, including new health technology assessment applications, safety and efficacy evidence literature materials, systematic review reports, and subcommittee/full committee review response materials.
Patent and Technology Transfer Documents
We prepare documents necessary for intellectual property protection and technology commercialization, including medical device patent applications, technical specifications, technology transfer agreements, and joint research agreements.
Process
Support Process
We provide systematic step-by-step support from medical device development to market entry.
01. Planning and Strategy Development
We develop an optimal regulatory strategy through medical device product classification verification, class determination, and regulatory requirement analysis. We review the applicability of the immediate market entry system and design the overall development roadmap.
02. Technical Documents and Testing
We prepare technical documents for demonstrating safety and efficacy, and design and coordinate with institutions for necessary tests including material compliance testing, electrical safety testing, and biological safety testing.
03. GMP and Clinical Trials
We establish the GMP quality management system and obtain compliance recognition. When necessary, we prepare clinical trial protocols and concurrently pursue IRB approval and MFDS IND approval to initiate clinical trials.
04. Regulatory Approval and Market Entry
We process MFDS approval/certification/notification applications and respond to supplemental requests during the review process. When necessary, we apply for new health technology assessment and develop health insurance reimbursement listing strategies.
Medical Device Development Inquiry
We provide expert consulting from medical device regulatory strategy to clinical trial design.
Let us guide you through our tailored solutions.