Organization, quality manual and document register
Align scope, responsibilities, approvals and record controls with real operations.
Medical & healthcare
Demonstrate quality operations from development to updates
Owning documents and operating a quality system are different. Define product type, sites and outsourcing, then prepare development, testing, change and security response records. Specify supports editable documentation drafts, with optional expert review; assessment decisions remain with the relevant body.
Source record updated:
Discuss your certification →Scope and applicability
Korean regulatory assessment of manufacturing and quality management
NIDS performs digital medical device GMP conformity work. MFDS guidance distinguishes obligations for standalone and embedded software and clinical-trial hardware from voluntary provisions for class 1 and export products. Confirm individual applicability; conventional KGMP recognition is not identical to digital GMP.
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
- Manufacturers and importers of standalone or embedded digital medical software
- Teams adding AI/ML or changing sites and outsourcing
- Organizations preparing initial or periodic quality assessments
Documents to prepare
Representative product and test evidence
Prepare product specifications, process flows and finished-product test procedures and results.
Software change, security and supplier records
Connect release approval, change impact, cyber incident response, purchasing and supplier controls.
Internal reviews and corrective actions
Show issue detection, root-cause analysis, improvement and verification.
Preparation process
Confirm assessment scope and type
Distinguish conventional and digital GMP and define AI/ML and hardware/software manufacturing relationships.
Resolve operational gaps
Compare documents with practice and retain representative development, testing, release and change evidence.
Apply, correct and maintain
Complete the appropriate assessment and manage periodic and change-assessment triggers.
Timing
Evidence readiness, operating history, scope and assessment availability determine timing. Initial preparation is separate from periodic assessment application deadlines.
Agency fees
Digital GMP assessment fees
Current quotation for the assessment scope
Pricing depends on scope and application type. Distinguish digital medical device and conventional medical device GMP procedures.
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 GMP and Digital Medical Device GMP 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 ISO 13485 automatically exempt GMP?
No. Ask the relevant body whether existing certification and scope permit any substitution or omission under Korean rules.
Can adding AI change GMP requirements?
MFDS lists adding AI/ML as a change-assessment example. Confirm the actual scope for the change.
Which 2026 guidance should we check?
The catalog cites MFDS GMP guidance and the digital GMP Q&A announced on 2026-09-16. Recheck applicable forms before applying.