Quality Manager Requirements for Korean Medical Device Licence Holders

1. Key takeaways

Any entity holding a manufacturing licence or an import business licence must have a quality manager. This is a condition common to Article 6 and Article 15 of the Medical Device Act, and it is the point where commercial risk concentrates most heavily in the Korean licensed entity (KLH) system.

The statutory duties of the quality manager run along two main lines: first, establishing the quality management standards and supervising their observance; second, supervising compliance with regulatory matters. The duties cover the whole course from product quality standards and inspection records to the performance of post-market obligations; the position is not a nominal one.

The risk concentrates in the personnel status. A quality manager who holds concurrent posts, is long absent or is in post without registration puts the statutory conditions of the licence into an unmet state. What GRZAN has encountered in projects is a licensed entity whose quality manager left and was not replaced in time; the substantive conditions of the import business licence had already failed while the company kept importing, and the problem only surfaced at the annual inspection.

2. Legal basis

The quality manager requirement and its duties rest on the following instruments.

Duties of the quality manager and corresponding risks (supplementary table)

3. Expert insights

Insight 1: The quality manager is a licence condition, not an internal company post.

Companies often read the quality manager as an internal quality head, appointed and removed through internal personnel procedures. At the statutory level, this position is a constituent element of the licence, and personnel changes reach the licence status. GRZAN advises binding the appointment and removal of the quality manager to the reporting procedure in the policies of the licensed entity, so that the personnel action and the compliance action complete at the same time.

Insight 2: Concurrent posts are the highest-frequency risk pattern.

One person serving as quality manager for several entities at once, or concurrently holding a business role that conflicts with the quality duties, makes the condition of full-time dedication difficult to sustain. When GRZAN performs due diligence on a licensed entity, full-time dedication is the first item checked, before credentials and experience.

Insight 3: The risk of absence is well hidden.

After a person leaves, the business continues, the licence is not revoked, and everything looks normal on the surface. The real risk surfaces together at inspection and traceability: the quality records, inspection records and post-market reports of the absence period lack the signature of a statutory responsible person and are hard to evidence in traceability. The longer the absence, the higher the cost of explaining it when exposed.

Insight 4: The duty boundary must land in documents and signatures.

The duties of the quality manager must be supported by policy documents and leave signature traces on inspection records, release records, adverse event reports and similar documents. GRZAN advises companies to list explicitly in the system documents which records must be signed by the quality manager, turning the duties from text into verifiable records.

4. Practical recommendations

• Write the full-time dedication of the quality manager into the licensed entity agreement. Stipulate that no concurrent posts and no nominal postings across entities are allowed, and agree on a notice period before any change.
• Build a closed loop for reporting personnel changes. Departure, transfer and new appointment each have their own actions and deadlines; GRZAN advises producing a one-page process card for the licensed entity to execute.
• List the documents that must be signed by the quality manager. Inspection records, release records, adverse event reports and recall-related documents go on the list, with the completeness of signatures sampled periodically.
• Verify presence in post every six months. Cross-validate the employment certificate, the registration information and the signature records, and keep the verification on file.
• Put the quality manager into the responsible-person field of the compliance calendar. Mark items such as item renewal (every 5 years) and KGMP periodic audits (certificate valid 3 years) with a responsible person, so that no due item sits idle.

5. Verification checklist

• □ Position established: check the quality manager in the licence registration information; registered and up to date.
• □ Full-time dedication: check the employment certificate and other concurrent posts; no concurrent posting and no nominal postings across entities.
• □ Presence in post: check the employment certificate and attendance records; full-time presence with no long absence.
• □ Policy documents: check the policy text on quality management duties; covering both main lines of quality standards and regulatory compliance.
• □ Signature traces: sample the signatures on inspection, release and adverse event reports; complete and traceable.
• □ Change reporting: check the reporting records of personnel changes; reported promptly after each change.
• □ Periodic verification: check the six-monthly verification records; fully documented with intervals not exceeding 6 months.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, Korean licence holder and local testing support for the Republic of Korea. Our team manages MFDS premarket approvals and KGMP conformity, coordinates import requirements, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com