medical device

gmp assessment

'Quality inspection for medical device

KTC has been designated Quality System Auditing organization accredited by the Commissioner of KFDA.
In Korea, we are applying following quality control standard presently.

Manufacturer

Apply Korea Quality System Regulation for Medical Devices equivalent to ISO 13485:2003.
(Medical Device Affairs Enforcement Regulations Annex 3)

Importer

Apply Quality Control Guidelines based on Medical Device Affairs Enforcement Regulations.
(Medical Device Affairs Enforcement Regulations Annex 5)

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