Medical Device Quality Manager Requirements in South Korea — Qualifications, Duties, Training

Key takeaway — A quality manager is a statutory requirement in Korea: at least one per manufacturing site or import office (Enforcement Rule Article 11(1); applied to importers via Article 34). Qualification runs through ten routes — licenses, national technical qualifications, degrees, or experience — the role is in principle exclusive of other duties, and it carries a mandatory eight hours of training every year. The first gate of a business license is a person, not a document: if you are preparing a Korean import business license, secure the quality manager before you worry about warehouse and facility standards. Verified against the statutory texts as of August 2026.

Why this is the first gate of the license

Whether it is an import business license or a manufacturing business license, the application includes a quality manager. A manufacturing business licensee must appoint at least one quality manager per manufacturing site (Enforcement Rule Article 11(1)); importers apply the same provisions to the import office (Act Article 15(6) and Enforcement Rule Article 34, reading "manufacturing site" as "import office" and "manufacture" as "import").

What makes this requirement hard in practice is that it is about a person, not paperwork. The first wall a small importer hits while preparing the import process is usually "where do we find a qualified quality manager?" Knowing the qualification routes precisely keeps you from narrowing your hiring requirements more than the law does.

Who qualifies — the ten routes (Enforcement Rule Article 11(2))

Route	Requirement	Note
Medical technician license	Optician (spectacle/contact lenses), dental technician/hygienist (dental materials), radiological technologist (radiation-emitting devices), physical therapist (physiotherapy/rehabilitation devices)	Limited to companies handling that product type
National technical qualification	Medical electronics engineer (uigong-gisa) or quality management engineer	No product-type limit
Accredited private qualification	Medical device RA (Regulatory Affairs) expert qualification accredited by the MFDS	Route added by the December 2022 amendment
Bachelor's degree, related major	Natural sciences, engineering, or medicine	No experience required
Bachelor's (other major) + master's	Master's degree or higher in a medical device-related field	No experience required
Bachelor's (other major) + experience	One year of quality-control work	Experience before graduation counts
Junior college, related major + experience	One year of quality-control work
Junior college, other major + experience	Three years (two for three-year programs)
High school + experience	Five years (three for medical device-track vocational high schools)
Experience only	Six years of quality-control work at a medical device manufacturer/importer	No academic requirement

All experience means quality-control work at a medical device manufacturer or importer. Where two or more quality managers are appointed, their duties must be divided with clear boundaries of responsibility (Article 11(3)).

What the role does — scope of duties (Enforcement Rule Article 12)

Act Article 6-2(1) sets the outline — supervising production staff, and managing manufacturing, quality, and safety (including post-market adverse event safety management) — and Enforcement Rule Article 12(1) fills in the detail. The skeleton:

• Checking staff hygiene and providing training, and supervising its completion
• Writing the standard operating procedures under the manufacturing and quality system standards of [Annex 2], and making sure production follows them
• Test and inspection from raw material intake to finished product release, and preparing per-lot manufacturing and quality records — kept for five years (or the product's lifetime if longer)
• Evaluating quality-control results

For importers, "manufacture" in these duties reads as "import." In other words, the quality manager is the person at the center of building and keeping the records that a KGMP documentation system runs on.

Concurrent duties — prohibited in principle, two exceptions

A quality manager may not, in principle, hold duties other than the above (Enforcement Rule Article 12(3)). There are only two kinds of exception:

1. Duties that do not affect the quality manager's own work
2. Cases such as a manufacturer that also runs an import business, where the manufacturer's quality manager also serves the import entity

The same article provides a non-service report to the regional MFDS office when the quality manager stops working (e.g., leave of absence). The structure does not accommodate a name-only appointment.

Training — eight hours a year, six months for new appointees

• Content: latest standards, safety-management law and technology, manufacturing and quality-control law and technology (Enforcement Rule Article 13(1))
• Hours: eight or more per year (Article 13(2))
• New appointees: training at a designated institution within six months of starting (Article 13(3); exempt if that year's training is already completed)
• Enforcement structure: assigning an untrained person to the role is itself prohibited (Act Article 6-2(4))

Read it together with the facility standards

Business license requirements come as a set: the person (quality manager) and the place (facilities). For manufacturers the basis is Enforcement Rule Article 8(1) and [Annex 2] Standards for Facilities and Manufacturing/Quality Systems; for importers, Article 31(1) and [Annex 4] Standards for Import Business Facilities and Manufacturing/Quality Systems. Office and warehouse (storage) requirements come from these annexes, so check them before signing a lease. The principle that business requirements and product procedures should run in parallel is covered in the overview guide.

Common mistakes

• Preparing the product dossier first and then failing to find a quality manager — hiring (or confirming a qualification route) is the longest lead time
• Applying the medical technician license route without checking the product-type limitation
• Missing the six-month training deadline for a new appointee
• Assigning side duties that do not fall under the Article 12(3) exceptions

Checklist before you proceed

• Identify the candidate's qualification route (license / qualification / degree / experience — list the supporting documents)
• For experience routes, confirm that certificates of medical device quality-control work can be obtained
• If concurrent duties are planned, review the Article 12(3) exceptions
• Schedule the new appointee's training within six months
• Check the office and storage against Annex 2 (manufacturing) or Annex 4 (import)

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Checked before the job posting, the quality manager requirement gives you options; checked right before filing, it costs you the schedule. Send us a candidate's education and career summary and the free preliminary review will map their qualification route and the documents to prepare.