Agency
All medical devices are regulated by the Ministry of Health (MOH).
Medical Device Definition
Medical devices are instruments, apparatuses, machines and/or implants that do not contain medicines used to prevent, diagnose, cure and relieve diseases, treat sick people, recover human health and/o r form structures and correct the body function. Based on the objective of use as meant by the producer, medical devices may be used individually or in combination for human beings with one or several purposes as follows:
- Diagnosis, prevention, monitoring, treatment or reduction of diseases;
- Diagnosis, prevention, monitoring, treatment or reduction of diseases;
- Diagnosis, monitoring, treatment, reduction or compensation of sick condition;
- Investigation, replacement, modification, anatomical support, or physiological process;
- Support or maintain life;
- Obstruct fertilization;
- Disinfectant of medical devices;
- Provide information for medical or diagnosis purposes through the in vitro test on the specimen and human body
Classification of Medical Device
International Classification |
Examples |
Risk Level |
A |
Cholesterol, uric acid test system; Surgical Instrument; Bandage, Surgical camera; Electric operating table, Patient scale |
Low |
B |
Pregnancy self testing, Electric Hospital Bed, Surgical Lamp, Surgical Mask |
Low - Moderate |
C |
Blood glucose self testing, ECG, X-ray Unit, Syringe, Condom, Contact lens |
High - Moderate |
D |
HIV Blood donor screening, Stent, Intraocular lens (IOL), Defibrillator, Pacemaker |
High |