Therapeutic purpose and product specification
Define disease, patients, users, duration, environment, intervention and functions.
Medical & healthcare
Connect therapeutic claims with clinical and software evidence
Digital therapeutics require a defined therapeutic purpose, product classification and evidence supporting safety and effectiveness. Plan clinical, software, usability and quality work around the claimed intervention.
Source record updated:
Discuss your certification →Scope and applicability
Korean product authorization for therapeutic digital medical devices
Confirm the Digital Medical Products Act route for the product's class and submissions using MFDS DTx guidance. Clinical adoption, new health technology assessment and reimbursement may require separate procedures after authorization.
Korean certification schemes and international standards are different. A translated guide does not extend a Korean certificate to other countries. Confirm the target market, product classification and current requirements with the relevant body.
Who this is for
- Developers of software-based therapeutic interventions
- Teams converting therapeutic concepts into regulated products
- International DTx providers considering Korean market access
Documents to prepare
Clinical evaluation and trial evidence
Prepare study design, endpoints, statistics, safety management and evidence; check plan approval needs first.
Software, security and usability evidence
Link verification and controls for safety, use errors and security to the program and version.
Quality and post-release plan
Address GMP, content and algorithm changes, defects, complaints and safety information.
Preparation process
Define claims and regulatory route
Clarify clinical role, evidence objectives and issues for authority consultation.
Prepare clinical, software and quality work
Confirm trial approvals and ethics review and coordinate studies, verification, risks, usability and QMS.
Apply and plan clinical introduction
Respond to review requests and separately assess clinical adoption, evaluation and reimbursement routes.
Timing
Study design, recruitment, follow-up, verification and corrections strongly influence duration. Authority processing time alone cannot establish the launch date.
Agency fees
Digital medical device manufacturing or import business license application
Online: KRW 144,000
Enforcement Rule Schedule 16 lists KRW 160,000 for in-person or postal applications. Product authorization, GMP, testing and consulting are separate.
Sources and references ↗Digital medical device manufacturing or import product authorization
Online: KRW 158,000 / 719,000 / 1,495,000
Respectively: no review; other review; review of clinical evaluation data, change management plans or professional-use software materials. Confirm certification and notification fees separately. These are application fees, not total project prices.
Sources and references ↗Digital medical device clinical trial plan approval
Online: KRW 2,375,000
In-person or postal: KRW 2,639,000. This is an application fee, not hospital, CRO or participant recruitment costs. Confirm applicability and reductions when applying.
Sources and references ↗Document automation and management cost KRW 300,000 per month. Expert services and certification body testing or assessment fees are separate. Specify supports preparation; the relevant authority or certification body makes the final decision.
Pricing and certification costs →Optional expert consulting
Expert review and consulting are optional, separately scoped services. Choose support for Digital Therapeutics (DTx) Regulatory Approval based on your team's readiness and the evidence or assessment preparation you need.
- Confirm institutional testing, assessment and registration fees separately in the contract.
- Development fixes, clinical studies where applicable, security equipment and infrastructure operations may require separate budgets.
- Confirm internal staffing, travel, translation, VAT, surveillance and renewal costs in the quotation.
Questions and answers
Can a wellness app immediately become an approved DTx?
Therapeutic claims need appropriate classification and safety and effectiveness evidence. Wellness usage alone does not establish therapeutic benefit.
Does approval guarantee insurance reimbursement?
No. Product authorization and reimbursement or health technology decisions are separate.
Can we update content and algorithms?
Manage versions and assess effects on authorized claims, performance and risks, then confirm the required change procedure.