In vitro diagnostic medical device manufacturing and import GMP audit

In vitro diagnostic medical device GMP in Korea (MFDS)

In vitro diagnostic medical device GMP (Good Manufacturing Practice)

The in vitro diagnostic medical device GMP system refers to a quality guarantee system to ensure that in vitro diagnostic medical devices produced and imported are safe, effective, and consistently produced quality products suitable for intended use. Companies that want to produce and import in vitro diagnostic medical devices need to secure systematic quality systems for the entire process, such as designing and developing, manufacturing, and post-marketing management of in vitro diagnostic medical devices, and must obtain GMP approval.

In vitro diagnostic medical device GMP audit target

• Manufacturer or importer of in vitro diagnostic medical devices.
• Manufacturer or importer of in vitro diagnostic medical devices for clinical performance testing.
• Manufacturers or importers of in vitro diagnostic medical devices who wish to be recognized for suitability and undergo regular screening.

In vitro diagnostic medical device GMP audit item group

It is classified into nine GMP item groups according to the characteristics of each item, and GMP suitability is recognized for each item group. (Additional review is required when adding item groups)

In vitro diagnostic medical device GMP audit classification

1

Initial audit
In vitro diagnostic medical devices manufactured or imported for the first time to be recognized as meeting GMP standards.

2

Regular audit
Regular examination of GMP application performance that must be received once every three years in accordance with the Enforcement Rules of the In Vitro Diagnostic Medical Devices Act and GMP Notice (application for regular examination 90 days before the expiration of the validity period of the appropriate certificate).

3

Additional audit
Examination received in cases where in vitro diagnostic medical devices of other item groups are to be manufactured or imported pursuant to attached Table 3 of the GMP Notice.

4

Change audit
Examination received when the location of the manufacturer is changed (transferred) (excluding changes in storage and laboratory that are less related to the quality of the product).

In vitro diagnostic medical device GMP audit method

In vitro diagnostic medical device GMP audit subject (exclusive: examination agency, joint: local food agency/examination agency)

In vitro diagnostic medical device GMP audit method

Application for in vitro diagnosis medical device GMP audit

In vitro diagnostic medical device GMP audit application

Submit the required documents to the examination agency in an application for audit, such as recognition of suitability, etc.

• Application for audit, such as in vitro diagnostic medical device suitability recognition, etc.
• A copy of the in vitro diagnostic medical device manufacturing (import) business license or a copy of the conditional manufacturing (import) business license (excluding in the case of in vitro diagnostic medical devices for initial examination or clinical performance testing).
• Data necessary for the audit, such as conformity recognition, etc.
• A copy of the audit result notice, such as in vitro diagnostic medical device technical document, etc. (in the case of in vitro diagnostic medical devices for clinical performance testing, technical documents, etc.)

※ Quality control performance of at least one manufacturing unit is required for representative items (with a completed product test report).

In vitro diagnostic medical device GMP audit procedure

In vitro diagnostic medical device GMP audit procedure

In vitro diagnostic medical device GMP evaluation criteria

In vitro diagnostic medical device GMP requirements

In vitro diagnostic medical device GMP process

In vitro diagnostic medical device GMP requirements

Application of GMP monitoring standards for suitability of in vitro diagnostic medical devices

Usability refers to design features (e.g., buttons, user screens, user manuals, etc.) designed to reduce the risk of use errors that may occur when using a product and allow users to accurately and safely use in vitro diagnostic medical devices.
GMP usability application is implemented step by step for each in vitro diagnostic medical device grade, and quality control techniques that apply usability when designing and developing in vitro diagnostic medical devices should be specifically presented and applied to in vitro diagnostic medical device manufacturers.
In vitro diagnostic medical device usability design and evaluation consist of steps such as (1) preparation of specifications for use, (2) safety check of user interface, (3) preparation and selection of related scenarios for predictable hazards, (5) establishment of user interface specifications, and (7) general evaluation of user interface usability.

From January 1, 2021 to July 1, 2022, it will be implemented in stages by grade.

Introduction of in vitro diagnostic medical device standard code (UDI) system

Manufacturers and importers of in vitro diagnostic medical devices must mark standard codes (number indicated according to standardized systems, bar codes including electronic tags, etc.) on the container or exterior of in vitro diagnostic medical devices.

From July 1, 2019 to July 1, 2022, it will be implemented in stages by grade.

Post-management of in vitro diagnostic medical devices

Report on in vitro diagnostic medical device foreign substance

Manufacturing, import, and repair companies of in vitro diagnostic medical devices must prepare and submit the previous year's production, export, import, and repair performance once a year from January 1st to January 31st every year.

Report on the supply of in vitro diagnostic medical devices

In vitro diagnostic medical devices manufacturing, importing, selling, and leasing companies must submit a "supply breakdown report" to the Minister of Food and Drug Safety through the Integrated Medical Device Information System" by the end of the following month.

From July 1, 2020 to July 1, 2023, it will be implemented in stages by grade.

In vitro diagnostic medical device

If an in vitro diagnostic medical device handler finds a substance (foreign substance) that may cause harm or is inappropriate to use when used as it is not a raw material used normally inside, containers, or packaging the in vitro diagnostic medical device, he/she shall immediately submit a Foreign Object Discovery Report to the Ministry of Food and Drug Safety.

In vitro diagnostic medical device abnormality report

If an in vitro diagnostic medical device handler recognizes that death or serious side effects may occur or occur while using the in vitro diagnostic medical device, he/she must submit the Medical Device Abnormal Case Report to the Minister of Food and Drug Safety from the date he/she knows it to the next day.

In vitro diagnostic medical device GMP consulting stage in Korea (MFDS)

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