Scope and system architecture
Identify applicant, product, version, institution type and development and operating scope using current forms.
Medical & healthcare
Map EMR functionality, interoperability and security to evidence
Korea's EMR scheme distinguishes certification of a developed product from certification of its use in a healthcare institution. Prepare evidence and demonstrations for the relevant functionality, interoperability and security criteria.
Source record updated:
Discuss your certification →Scope and applicability
Korean EMR product certification and healthcare institution use certification
This is not a universal authorization for medical software and is separate from medical device and privacy obligations. Confirm product, use or simultaneous application scope for self-developed systems. The catalog references 2026 (v1.2) criteria and application forms revised 2026-05-08.
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
- EMR system developers
- Healthcare institutions implementing certified EMR products
- Institutions developing their own EMR systems
Documents to prepare
Criteria checklist and functional evidence
Map record creation, storage and management functions to criteria and demonstrations.
Interoperability and security evidence
Prepare information exchange, access and logging implementation and operating records, with grounds for exemptions.
Institutional use evidence
For use certification, document deployment, actual use and changes to the certified product.
Preparation process
Confirm applicant and route
Distinguish product, use and eligible simultaneous applications and institution type.
Check and improve functions
Resolve gaps and create criterion-level evidence and demonstration scenarios.
Apply, assess and correct
Follow portal review and on-site assessment procedures and plan renewal and change management.
Timing
Implementation readiness, integration and security corrections and assessment availability affect timing. Check criteria transition dates and renewal applicability.
Agency fees
EMR institutional assessment fees
Confirm the current application conditions
Check fees by application type, scope and support eligibility. External consulting and development costs are separate.
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 Electronic Medical Record System Certification 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
How do product and use certification differ?
Product certification covers the EMR system; use certification covers a healthcare institution's use of a certified product. Self-developing institutions should check simultaneous application eligibility.
Does EMR certification remove medical device approval needs?
No. Assess added diagnostic or therapeutic functions separately for medical device applicability.
Can we reuse older criteria unchanged?
Check the applicable 2026 criteria, forms and transitional conditions for initial or renewal applications and update evidence accordingly.