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KGMP: On-site Inspection or Document Review? CMEF Open Class Exclusive Insights

Time：2026-10-26 14:09:37

To enter the South Korean medical device market, KGMP (Korean Good Manufacturing Practice for Medical Devices) is an indispensable access threshold. Many manufacturers mistakenly believe that holding an ISO 13485 certificate guarantees market clearance, which is not the case. South Korea’s MFDS follows an independent audit framework: you may choose either on-site inspection or document review if you meet qualifying criteria. The two pathways differ greatly in cost, timeline and certificate validity. Compiled from our open class at CMEF Beijing, this article breaks down the decision-making logic of KGMP and helps Chinese medical device manufacturers clarify pathway selection, document preparation and common QMS gaps.

一、Does Your Product Require KGMP?

South Korean medical devices are classified into Risk Class I–IV. This classification system does not directly align with the 3-tier classification of China’s NMPA; classification must follow the official MFDS determination.

Class II, III & IV Devices：Mandatory KGMP audit. The manufacturing site and corresponding product family must hold a valid KGMP certificate for manufacturing and import into Korea.

Class I Devices：Exempted from KGMP audit, but compliance obligations remain. Enterprises still need to abide by Korean regulations and retain complete quality records. Routine initial and triennial surveillance audits will not be enforced.

Key Takeaway：Exemption ≠ exemption from compliance. Class I manufacturers must also establish QMS documentation aligned with Korean regulatory requirements.

Which manufacturing sites fall within audit scope?

KGMP audits define covered facilities based on finished medical devices and legal accountability：

Actual manufacturing site：Where all or core production processes are performed; this is the primary audit target.

Legal manufacturer：Bears legal responsibility under contract manufacturing arrangements and may be audited separately or together with the production site.

Outsourced processes and critical suppliers (e.g., outsourced sterilization, packaging)：Auditors may extend the scope to these outsourced locations during the host site audit. Random spot-checks are possible.

Practical Tip：Map all facilities associated with finished products before application, to avoid project delays caused by adding new sites mid-audit.

二、On-site Inspection VS Document Review

KGMP audits fall into four categories：Initial Audit, Additional Audit, Change Audit, Surveillance Audit (Recertification). Eligibility for document review (waiving MFDS auditor travel to China) depends on the audit type.

Audit Type	Definition	Eligible for Document Review
Initial Audit	First-time KGMP application for the facility	Document review allowed with a qualified MDSAP report; standalone standard ISO13485 certificates cannot replace on-site inspection
Additional Audit	Add new product families to an existing KGMP certificate	Eligible with MDSAP or Notified Body-issued EN ISO13485 certificate, subject to conditions
Change Audit	Manufacturing site relocation (excluding warehouses and laboratories)	Eligible with MDSAP or Notified Body-issued EN ISO13485 certificate, subject to conditions
Surveillance Audit (Triennial Recertification)	Certificate renewal upon expiry	On-site inspection mandatory; document review is not permitted

（一）Conditions to qualify for document review (waiving on-site visit)

Condition 1: MDSAP Audit Report

A standalone MDSAP certificate is insufficient. A full initial or recertification audit report is required; surveillance audit reports are not accepted. The report must satisfy all four criteria:

Report type：Only initial or recertification audit reports. Annual surveillance reports are invalid.

Scope alignment：MDSAP certification scope is relevant to the KGMP application product scope.

Non-conformity grading：Zero Grade 5 critical non-conformities, maximum one Grade 4 non-conformity.

CAPA for all non-conformities has been verified and closed by the MDSAP Auditing Organization (AO).

Exception: Surveillance audits, outstanding major MDSAP non-conformities, combination products and human-origin material devices require on-site inspection even with valid MDSAP records.

Condition 2: EN ISO 13485 issued by an EU Notified Body

Only applicable for Additional Audit and Change Audit document review. It cannot replace on-site inspection for Initial KGMP Audit. ISO13485 certificates issued by general commercial certification bodies are not accepted by MFDS for document review.

Condition 3: Existing valid KGMP certificate for the same site

Where the manufacturing site already holds a valid KGMP certificate under Korean Importer A, a new Korean Importer B for the identical site, product family and unchanged QMS may apply for document review. The new certificate shares the expiry date of the original KGMP certificate; it does not reset the 3-year validity period.

（二）Core Differences: On-site Inspection vs Document Review

Item	On-site Inspection	Document Review
Cost	Audit fee + travel, interpretation and on-site hosting expenses	Only KGMP audit fee; no travel overhead
Timeline	Longer, subject to auditor scheduling, visa and travel arrangements	Shorter turnaround, no auditor travel required
Certificate Validity	Valid for 3 years from issuance date	Expiry aligns with the reference certificate (MDSAP / existing KGMP), validity may be less than 3 years

Risk Alert：While MDSAP-based document review is faster, its expiry follows the MDSAP cycle, which may shorten your KGMP validity. Evaluate full-lifecycle costs instead of focusing only on one-time audit expenditure.

三、Application Practice

（一）Application Party: Korean Importer is the official applicant; Chinese factory provides full documentation

Overseas Chinese manufacturers cannot submit KGMP applications directly to Korean authorities.

Korean Importer: Legal applicant, submits forms, liaises with audit body and responds to deficiency letters.

Chinese Manufacturer: Supplies facility, QMS and product documentation; hosts on-site audit and completes CAPA for non-conformities. Both parties coordinate audit scheduling and evidence follow-up.

（二）Timeline Planning: 6-month lead time recommended for on-site audits

For on-site audits, start preparation 6 months before the planned audit date. Key milestones:

After application submission: Confirm contacts, tentative audit window and factory availability.
6 months before audit: Reserve travel, visa and on-site interpreter resources.
3–4 months before audit: Complete KGMP gap analysis and finalize fully translated application dossiers.
1–2 months before audit: Run a mock pre-audit, close open CAPAs, confirm interviewees and audit route.
≥20 days before audit: Lock final audit agenda, evidence checklist, meeting room and on-site network setup.

四、High-Frequency Non-conformities for Chinese Manufacturers

KGMP audits are built on ISO13485:2016, with additional mandatory Korean local regulatory requirements. An ISO13485 certificate alone cannot substitute for a KGMP certificate, and these local requirements are the most common source of non-conformities.

Three Typical QMS Gaps

Gap 1: Korean medical device regulations missing from regulatory register

Issue: The enterprise regulatory list only references international standards and excludes the Medical Devices Act and KGMP standards.

Remediation: Add Korean regulations to controlled register and cross-reference with relevant SOPs.

Gap 2: Record retention fails Korea’s dual-clock rule

Korea requirement: Records must be retained satisfying both rules: 5 years from production completion AND minimum 2 years after market release. Records may only be destroyed once both retention windows are completed; use the longer duration.

Remediation: Update record retention SOP. Log production date and market release date for each batch, build a record retention matrix.

Gap 3: Missing adverse event reporting workflow for the Korean market

Issue: No documented procedure for reporting adverse events, recalls or safety alerts to MFDS and the Korean importer.

Remediation: Add Korea-specific workflow to vigilance SOP, define responsible roles, reporting deadlines and contact parties.

五、 FAQ

Q: Can KGMP audit and product registration run in parallel?

A: Parallel preparation is allowed, but KGMP certification is a precondition for market approval. KGMP outcomes directly determine registration approval status. Align project timelines closely.

Q: What are the impacts of audit postponement?

A: Audit delays will push back product registration and launch schedules. Build sufficient buffer time and create a backward-planned project roadmap.

六、Closing Remarks

The South Korean medical device market holds promising opportunities, yet KGMP follows distinct local rules, and an ISO13485 certificate alone cannot guarantee smooth market access. Whether you opt for cost-efficient document review or prepare for on-site inspection, early assessment of product classification, audit pathways and QMS gaps with thorough pre-work helps you avoid repeated rework and streamline Korean market entry.For further consultation, feel free to contact Wiselink!

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