KC Certification- Medical Devices | MFDS

 

 

KC Certification- Medical Devices | MFDS

A person intending to manufacture, import, or sell medical devices, including beauty products, must report to or obtain a permit from the Ministry of Food and Drug Safety of Korea (MFDS) and the National Institute of Medical Device Safety Information (NIDS) prior to 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 websites

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

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