Medical device law of Korea (MFDS)

The Medical Device Act in Korea stipulates the definition and permission of in vitro diagnostic medical devices, and is subdivided into enforcement ordinances and enforcement rules and contains the following details.

Definition of medical devices in Korea (MFDS)

Instruments, machines, devices, materials, or similar products used alone or in combination with humans or animals (Article 2 of the Medical Devices Act)

• Products used for the purpose of diagnosing, treating, mitigating, treating, or preventing
• Products used for the purpose of diagnosis, treatment, mitigation or correction of injury or disability.
• Products used for inspection, replacement, or deformation of structures or functions.
• product used to control pregnancy.

* However, among medicines and non-drugs under the Pharmaceutical Affairs Act and aids for the disabled under Article 65 of the Welfare of Persons with Disabilities Act, will and aids are excluded.

Classification of medical devices in Korea (MFDS)

Medical devices are classified into four classes according to the purpose of use and the degree of potential risk to the human body when used.

* Regulations on medical device items and classes by item (Notice No. 2018-15)
(Potential risk determination criteria: duration of contact with the human body / degree of invasion / whether drugs and energy are delivered to the patient / whether they have biological effects)

• Class 1 - Medical device with little potential risk
• Class 2 - Medical devices with low potential risk
• Class 3 - Medical devices with potential risk of severity
• Class 4 - Medical device with high risk

Medical device item classification in Korea (MFDS)

Korea (MFDS) Medical device licensing system

Before the market

As a manufacturer, the subject of pre-marketing regulation is managed by dividing it into clinical trials, item reporting, certification and permission, and GMP suitability recognition, a manufacturing system manager.

After selling it

Post-marketing regulations are under follow-up management through systems such as advertising pre-deliberation systems, side effects/safety reports, and re-evaluation and re-examination.

Medical device licensing procedure in Korea (MFDS)

Class 1 : Item report (immediately processed by the Korea Medical Device Safety Information Service, NIDS)

• Application for item report [Medical device electronic complaint counter] → Registration after registration is completed.
• Contents including technical documents: name (product name, item name, model name) / classification number (class) / shape and structure / purpose of use / method of use / precautions for use / manufacturer (in the case of import or manufacturing process consignment) / Remarks

Class 2 : Item certification (Provided by the Medical Device Safety Information Service or the Ministry of Food and Drug Safety depending on whether clinical trials are necessary)

• Item classification criteria.
• Equivalent product classification criteria: purpose of use, principle of operation, raw material, performance, test standard, and method of use (raw material in the electric field is excluded from judgment criteria).
• New Product: Medical devices that have already been approved, and medical devices that do not have the same purpose of use, principle of operation, or raw materials (only medical supplies)
• Improved products: Medical devices that have already been approved, the purpose of use, the principle of operation, and raw materials (only for medical supplies), are equivalent, but the performance, test standards, and methods of use are not equivalent.
• Equivalent product: Medical devices that have already been licensed, such as purpose of use, principle of operation, raw materials (only medical products), performance, test standards, and method of use are equivalent.

Class 3-4 : Item permission (consideration and progress at the headquarters of the Ministry of Food and Drug Safety)

• Class 2 and flow are the same. The review period for technical documents is 65 days and 80 days for collective application for permission, and there is a difference in the period.

Certification of products subject to comparison of class 2 essential equivalent items

Medical device GMP in Korea (MFDS)

Medical device GMP stipulates the requirements of the quality management system applied to the design, development, production, installation, and service of medical devices.
Detailed GMP requirements can be found in the 「Medical Device Manufacturing and Quality Control Standards Notice」.
It applies to all medical device manufacturers and importers, and the types of screening are divided into document screening and on-site screening.
After the initial examination, you must undergo a regular renewal examination every three years. If additional items other than the medium-sized items classified by GMP occur, there may be additional on-site inspections if the location is changed.

Medical device RA consulting stage in Korea (MFDS)

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