KC Certification-Medical Devices | MFDS

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KC Certification-Medical Devices MFDS


KC Certification-Medical Devices | MFDS


Medical devices, including beauty products, are subject to reporting or permitting requirements from the Ministry of Food and Drug Safety of Korea (MFDS) and the National Institute of Medical Device Safety Information (NIDS) for individuals or entities intending to manufacture, import, or sell such products before engaging in any trading activities.

Depending on the purpose of use and degree of risk, a medical device can be rated from Class 1 through Class 4. A manufacturer, importer, or distributor may sell products only after a GMP inspection for company license and product approval.

An overseas manufacturer can file an application through a domestic importer or a proper local agency, and a manufacturer, importer, and agency can get a license after confirming no quality issues during the GMP inspection.



▮ Classification of medical devices

Depending on the purpose of use and degree of potential risk during use, a medical device can be rated from Class 1 through Class 4.

Class 1

Devices with almost no potential risks

Mercury sphygmomanometer, electric bed, medical head lamp

Class 2

Devices with relatively low potential risks

Low frequency stimulator, X-ray machine for diagnosis, ultrasound stimulator, ultrasonic blood flow meter, dental X-ray machine, laser blood flow meter

Class 3

Devices with Intermediate level of potential risks

Universal electrosurgical unit, intracorporeal laser lithotripsy machine, medical laser irradiator, personal combination stimulator

Class 4

Devices with high potential risks

Cardiopulmonary bypass system, artificial heart, pacemaker



▮Required documents

- Test report (CB accepted)

- Risk management

- Software validation

- Usability

- Performance test in Korea

- Technical document

- GMP (Quality system assessment)



▮ Related website

Ministry of Food and Drug Safety: https://www.mfds.go.kr

National Institute of Medical Device Safety Information: https://www.nids.or.kr





👉 Contact GCA

Tel. +82-31-360-8180
Email: forest.lee@gca-kr.com


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