KGMP Conformity Assessment Guide — Audit Types, Required Documents, Overseas Site Preparation

Key takeaway — KGMP is an audit not of the "product" but of the "system that makes it." It is the de facto rite of passage for Class 2+ medical devices, and in import projects, the overseas manufacturer's level of cooperation is the schedule. ISO 13485 helps, but it is not a waiver.

What KGMP looks at

Where product licensing asks "is this product safe and effective," KGMP (Korea Good Manufacturing Practice for medical devices) asks "can this manufacturing site make such products consistently." The audit target is the site's quality system — documents, records, equipment, personnel, and the shop floor where they actually operate.

For Class 2+ products, conformity assessment of the manufacturing site effectively comes as a package with manufacturing or importing (see the class-by-class procedures), and even some Class 1 products, such as sterile devices, fall within scope as exceptions.

Audit types — which audit, and when

Audit	When	Characteristics
Initial audit	First conformity assessment for that site	Documents + on-site, heaviest preparation burden
Additional audit	Adding product groups to an already-conforming site	Focused on the scope of change
Change audit	Changes to location, critical processes, etc.	Impact assessment of the changes
Periodic audit	Renewal when the validity period arrives	Confirms the system is maintained

For imports, this audit targets the overseas manufacturing site, and the combination of document review and on-site audit is determined case by case.

The quality system document framework

• Quality manual and procedures — The system spanning design, purchasing, production, inspection, release, complaint handling, and CAPA (corrective and preventive action)
• Device master record documents — The standards for 'how the product is made and how it is inspected'
• Records — Evidence that operations actually followed the procedures. What auditors dig into most is not the manual but the records
• Validation — Advance validation of processes whose results cannot be fully verified by inspection, such as sterilization and other special processes
• Training and equipment management — Personnel qualifications and equipment suitability

A site with an ISO 13485 system already has much of this framework. The practical work starts with a gap analysis between "what exists" and "what Korea requires."

Overseas site audits — the real reasons for delay

When KGMP falls behind in import projects, the cause is usually not technical but the structure of cooperation.

The "why should we?" wall. From the manufacturer's perspective, KGMP is another country's audit. It routinely slips down their priority list, so an audit cooperation clause in the contract is the only reliable lever.

Document language and format. Underestimating the workload of reshaping the manufacturer's documents into a form Korean auditors can read is how schedules collapse.

On-site readiness. On audit day, the questions go to shop-floor records, not documents. Facing an on-site audit without a mock inspection turns small record gaps into deficiencies.

Preparation checklist

• Target site and product groups fixed, audit type confirmed
• Manufacturer's existing systems (ISO 13485, etc.) confirmed → gap analysis
• Document supply and on-site audit cooperation obligations reflected in the contract
• Schedule secured for document collection, translation, and organization
• Mock on-site inspection planned
• Parallel schedule designed with the technical file review

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Half of KGMP is designing the collaboration with your manufacturer. Send the site details (country, existing certifications, product groups) for a free pre-review, and we will draft a gap analysis of the audit type and preparation scope.