Medical device manufacturing and import GMP audit

Medical device GMP in Korea (MFDS)

Medical device GMP (Good Manufacturing Practice)

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

Medical device GMP audit target

• Manufacturer or importer of medical devices
• Manufacturer or importer of medical devices for clinical testing
• Manufacturers or importers of medical devices who intends to undergo conformity recognition and regular examination

Medical device GMP audit item group

It is classified into 26 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)

Medical device GMP items

Medical device GMP audit classification

1

Initial audit
The first examination to be recognized that manufactured or imported medical devices conform to 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 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 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).

Medical device GMP audit method

Medical device GMP audit subject (exclusive: examination agency, joint: local food agency/examination agency)

Medical device GMP audit method

Application for medical device GMP audit

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

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

Medical device GMP audit procedure

Medical device GMP audit procedure

Medical device GMP evaluation criteria

Medical device GMP requirements

Medical device GMP process

Medical device GMP requirements

Application of GMP monitoring standards for suitability of 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 medical devices.
GMP usability application is implemented step by step for each medical device grade, and quality control techniques that apply usability when designing and developing medical devices should be specifically presented and applied to medical device manufacturers.
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 the medical device standard code (UDI) system

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

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

Post-management of medical devices

Report on the results of medical devices

Manufacturing, import, and repair companies of 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 medical devices

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.

Report on medical device foreign substance

If an 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 medical device, he/she shall immediately submit a Foreign Object Discovery Report to the Ministry of Food and Drug Safety.

Medical device abnormality report

If an medical device handler recognizes that death or serious side effects may occur or occur while using the 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.

Medical device GMP consulting stage in Korea (MFDS)

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