Agency
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:
- 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.
Medical Devices Importation Regulations, Art. 2.
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 |