All medical devices are regulated by the Food and Drug Administration (JFDA) under the Ministry of Health (MOH).
Medical Device Definition
Every device / tool / material / or item used separately or engaged with other including all programs needed for operating same which are prepared by the manufacturer for human use for the purpose of achieving any of following:
Medical Devices Importation Regulations, Art. 2.
- Diagnosis, prevention, supervision, treatment or reduction of diseases.
- Diagnosis , supervision, reduction of / usage instead of any damage.
- Diagnosis, replacement / or amendment to the physiological situation.
Classification of Medical Device
|International Classification||Examples||Risk Level|
|I||Cholesterol, uric acid test system; Surgical Instrument; Bandage, Surgical camera; Electric operating table, Patient scale||Low|
|IIa||Pregnancy self testing, Electric Hospital Bed, Surgical Lamp, Surgical Mask||Low - Moderate|
|IIb||Blood glucose self testing, ECG, X-ray Unit, Syringe, Condom, Contact lens||High - Moderate|
|III||HIV Blood donor screening, Stent, Intraocular lens (IOL), Defibrillator, Pacemaker||High|
|Validity||Four years unless other certification expires first.|
|Postmarket Surveillance ||Some controls in place.|
|Timeline||Low risk: approx. 4 months. High risk: approx. 8 months.|