Intended use and classification review
Define disease, users, inputs, outputs, environment and clinical role, with the rationale for classification, grade and route.
Medical & healthcare
Start medical software approval with its intended use
The applicable route depends on diagnostic or therapeutic claims, users and the effect of outputs on clinical decisions. SaMD describes standalone medical device software, not a single certification product. Specify helps draft documentation from source code for your team to edit and manage. Optional expert review is separate; the relevant authority decides approval.
Source record updated:
Discuss your certification →Scope and applicability
Applicable Korean manufacturing, import and product regulatory procedures
Digital medical devices fall under Korea's Digital Medical Products Act, with relevant application of medical device or in-vitro diagnostic legislation where needed. As of 2026-10-24, distinguish the Act effective 2026-10-08 from amendments scheduled for 2027-03-16. Existing authorized products require transition and change review.
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 diagnostic, therapeutic, predictive or monitoring software
- Medical imaging, biosignal AI and clinical decision support teams
- Importers of overseas medical software or teams changing authorized functions
Documents to prepare
Software design and verification
Connect requirements, architecture, versions, test plans, results and traceability to claimed functions.
Safety and effectiveness evidence
Organize risk, usability, performance, clinical and security evidence around product requirements.
Manufacturing, quality and changes
Define sites, outsourcing, QMS and GMP scope and post-release update controls.
Preparation process
Confirm classification and applicable law
Review medical purpose, device type, existing authorizations and exceptions; prepare unclear issues for authority consultation.
Plan submissions and verification
Build the route-specific evidence list and prepare software, security, performance, clinical and GMP work together.
Apply and prepare for release
Coordinate business and product procedures, respond to authority requests and plan labeling, reporting and updates.
Timing
Classification, clinical evidence needs, development maturity and corrections affect duration. Separate evidence preparation from authority processing time.
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 ↗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 Medical Device Software 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
Does every healthcare app need MFDS approval?
No. Intended use and functions determine the category; review applicable exclusions for the specific software.
Do GS or ISO 13485 complete product approval?
No. Software quality and organizational QMS certification do not automatically replace product-specific regulatory procedures.
Does adding AI require another review?
Assess effects on intended use, algorithms, performance, safety and quality systems, including product and GMP change requirements.