엠디웍스코리아

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Quality Management

GMP

GMP standards and inspection overview

GMP overview

GMP stands for Good Manufacturing Practice. It refers to a quality management system for medical devices that helps ensure products are consistently manufactured and controlled according to quality requirements.

Legal basis
  • Enforcement Rules of the Medical Devices Act
  • Standards for Manufacturing and Quality Management of Medical Devices
  • Enforcement Rules of the In Vitro Diagnostic Medical Devices Act
  • Standards for Manufacturing and Quality Management of In Vitro Diagnostic Medical Devices
  • Enforcement Rules of the Digital Medical Products Act
Scope of application
  • Medical devices
  • In vitro diagnostic medical devices
  • Digital medical products

GMP inspection overview

Inspection types
  • Initial inspection: The first inspection required for a manufacturing site to obtain recognition of conformity with GMP standards.
  • Additional inspection: A new inspection required when adding another device group under Annex 3 at each manufacturing site.
  • Change inspection: An inspection required to obtain a new conformity assessment when the manufacturing site address changes.
  • Periodic inspection: An inspection that each manufacturing site must undergo once every three years by device group after the initial inspection.
Inspection methods

On-site inspection

After reviewing submitted materials, an on-site audit is conducted to determine whether to grant conformity recognition (document review + on-site audit).

Document-only review

Conformity recognition is determined based on submitted materials alone.

GMP device groups
  • Medical devices: Standards for Manufacturing and Quality Management of Medical Devices
  • In vitro diagnostic medical devices: Standards for Manufacturing and Quality Management of In Vitro Diagnostic Medical Devices
  • Digital medical products: Standards for Manufacturing and Quality Management of Digital Medical Devices

GMP conformity assessment process

Diagram of the GMP conformity assessment process

GMP inspection bodies

1 TÜV SÜD Korea Ltd.
2 TÜV Rheinland Korea Ltd.
3 Korea Testing Laboratory (KTL)
4 Korea Testing & Research Institute (KTR)
5 Korea Testing Certification (KTC)
6 Korea Conformity Laboratories (KCL)

Required documents

Medical devices

Refer to the "Application for conformity assessment inspection," etc., under the Standards for Manufacturing and Quality Management of Medical Devices.

In vitro diagnostic medical devices

Refer to the "Application for conformity assessment inspection," etc., under the Standards for Manufacturing and Quality Management of In Vitro Diagnostic Medical Devices.

Digital medical products

Refer to the provisions on conformity determination for digital medical device software quality management standards, etc., in the Enforcement Rules of the Digital Medical Products Act.