Standards of Medical Device Good Manufacturing Practice (GMP) in South Korea (MFDS Notice No. 2023-31)

1. What this regulation is and why it matters

South Korea regulates medical device manufacturing quality through Medical Device Good Manufacturing Practice (GMP) requirements (often referred to in practice as K-GMP). MFDS Notice No. 2023-31 sets out detailed rules on:

• the scope of devices and regulated parties,
• types of GMP audits (e.g., initial, periodic, renewal, additional),
• how audits are conducted (document review vs. on-site),
• timelines for review and notification, and
• governance of GMP audit agencies and quality-manager training organizations.

Source: MFDS—Amendment Notice No. 2023-31 (May 12, 2023) Source: Attached PDF—Standards of Medical Device GMP (No. 2023-31)
(For the MFDS English regulations index page, see: MFDS—Medical Device Regulations (English).)

2. Legal basis, purpose, and scope

Legal basis and purpose

The Notice implements the GMP audit and standards framework under the Medical Device Act and its Enforcement Rule, prescribing matters necessary for:

• the manufacturing and quality control standards for medical devices, and
• the conduct of GMP audits and related administration.

Source: Attached PDF—Article 1 (Purpose)

Who it applies to

The Notice applies to medical devices as defined by law. It also clarifies that:

• devices intended only for export, and Class I medical devices, must comply with the standard except for the GMP audit requirement.

Source: Attached PDF—Article 3 (Scope)

Effective date

The Notice states it took effect on November 13, 2023.

Source: Attached PDF—Addenda

3. Key concepts and regulated organizations

GMP audit agencies (quality management audit agencies)

MFDS designates and manages quality management audit agencies (i.e., organizations that conduct GMP audits). The Notice provides requirements such as:

• criteria and procedure for designation, and
• obligations for independent audits and post-management.

Source: Attached PDF—Articles 7 & 12

Quality-manager training organizations

The Notice also sets out requirements for organizations that provide education and training for medical device quality managers, including conditions for designation and compliance.

Source: Attached PDF—Article 8

4. Classification of GMP audits

The regulation classifies GMP audits into (at least) the following types:

• Initial audit (for first-time GMP suitability recognition)
• Periodic audit (performed at least once every three years)
• Renewal (re-recognition) audit
• Additional audit
• Modification audit

The Notice also provides specific cases where a periodic audit may be exempted, including certain export-only or Class I devices, certain investigational medical devices, and certain combination/converged products.

Source: Attached PDF—Article 4 (Classification)

5. How GMP audits are performed

Baseline: follow the audit standards (Annex 2)

GMP audits are conducted in accordance with the audit standards in Annex 2. For investigational medical devices (for clinical trials), the Notice allows partial submission when applying for certain audits.

Source: Attached PDF—Article 5 (Audit Application)

On-site vs. document review

As a general rule, the initial audit includes an on-site audit at least once for each of the applicable manufacturing sites. However, for 64 specified product groups (Annex 4), the initial audit may be conducted as a document-only review (“independent audit”)—and a temporary GMP certificate can be issued in those cases.

Source: Attached PDF—Article 6 (Audit methods) & Annex 4

6. Submission package and review process

What you submit

To apply for GMP suitability recognition, the applicant submits:

• an application form (Annexed form), and
• supporting documents such as a quality manual, SOPs, records, and other evidence that the QMS is implemented as required.

The Notice also provides supplementation procedures if the submission is incomplete.

Source: Attached PDF—Article 5 & supplementation

Processing timelines (key operational deadlines)

Operationally important deadlines include:

• the audit agency notifies the applicant of the result within 30 days after receiving complete application materials; and
• if an on-site audit is required, the agency decides whether to conduct it within 10 days after completing the document review, and then notifies the final result within 30 days after the on-site audit is completed.

Source: Attached PDF—Article 9 (Processing timelines)

7. Certificates: validity, reissuance, and return

Validity

A GMP certificate is issued with a validity period of 3 years.

Source: Attached PDF—Article 8(9)

Reissuance and return

The Notice describes cases where a GMP certificate may be reissued (e.g., change of name/representative/address) and when a certificate must be returned (e.g., upon expiration, cancellation, or invalidation).

Source: Attached PDF—Article 10 (Reissuance) & Article 11 (Return)

8. Practical compliance checklist (for manufacturers/importers)

• Map your product group: confirm whether your product falls into the Annex 4 group eligible for document-only review; if not, plan for an on-site audit.
• Align your QMS evidence: ensure your quality manual, SOPs, and records demonstrate consistent control of production, process validation (as applicable), and CAPA.
• Plan for timelines: treat the 10-day/30-day decision and notification windows as baseline operational expectations when planning market entry.
• Maintain readiness for periodic audits: periodic audits occur at least every three years (unless exempted).

Primary legal text reference: Korean Law Information Center—Medical Devices Manufacturing and Quality Control Standards