엠디웍스코리아

Skip to main content Skip to main menu

Quality Assurance

GMP

GMP standards and inspection overview

GMP overview

GMP is an abbreviation of “Good Manufacturing Practice” and it means Quality Management System of Medical Device for ensuring that products are consistently produced and controlled according to quality standards.

Related regulations
  • Enforcement rule of the medical devices act
  • Standards of medical device Good Manufacturing Practice
  • Enforcement rule of the in vitro medical devices act
  • Standards of in vitro medical device Good Manufacturing Practice
  • Enforcement rule of the digital medical products act
Application target
  • Medical Device
  • In Vitro Medical Device
  • Digital Medical Products

GMP audit classification

Inspection types
  • Initial Audit : An audit that a manufacturing facility must undergo for the first time to be recognized as conforming to GMP standards
  • Additional Audit : An audit that must be newly conducted when adding medical devices of a different product group according to Appendix 3 for each manufacturing facility
  • Change Audit : An audit that must be newly conducted to receive recognition of conformity due to a change in the location of the manufacturing facility
  • Renewal Audit : An audit that a manufacturing facility must undergo once every three years for each product group after the initial audit
GMP audit method

On-site Audit

After reviewing the submitted data, an on-site audit is conducted to determine whether the suitability is recognized (document audit + on-site audit)

Document Audit

Based on the submitted data, an audit is conducted to determine whether the suitability is recognized

GMP Product Categories
  • Medical Devices : Medical Device Manufacturing and Quality Control Standards [Appendix 3] Medical Device GMP Product Categories
  • In Vitro Medical Devices : In Vitro Diagnostic Medical Device Manufacturing and Quality Control Standards [Appendix 3] In Vitro Diagnostic Medical Device GMP Product Categories
  • Digital Medical Products : Digital Medical Device Manufacturing and Quality Control Standards [Appendix] Digital Medical Product Type categories

GMP compliance assessment procedure

Diagram of the GMP conformity assessment process

GMP audit agency

1 TUV SUD Korea Ltd.
2 TUV Rheinland Korea Ltd.
3 Korea Testing Laboratory
4 Korea Testing & Research Institute
5 Korea Testing Certification Institute
6 Korea Conformity Laboratories

Required Documents

Medical Devices

Refer to the " Application for GMP Audit “ section of the 「Standards of medical device Good Manufacturing Practice」

In Vitro Medical Devices

Refer to the " Application for GMP Audit “ section of the 「Standards of In Vitro Medical Device Good Manufacturing Practice」

Digital Medical Products

Refer to the “Digital Medical Device Software Quality Management Standards Conformity Determination, etc.” section of the 「Enforcement Regulations of the Digital Medical Products Act」