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GHTF/SG1-N29R16:2005 : Information Document Concerning the Definition of the Term "Medical Device“
Dental devices Dentistry tools, drills, alloys & resins, dental floss
Ophthalmic & optical devices Contact lenses, optical lens, eye glasses, ophthalmoscope
Anesthetic/respiratory equipment Oxygen mask, anesthesia, breathing circuit, medical gas delivery unit
Technical aids for disabled Wheelchair, crutch, standing support, electrical bed
Class C
Device Class
Class B
Risk: Combination of the
Class A probability of occurrence of harm
and the severity of that harm
Device Risk
Medical Devices Bureau
MINISTRY OF HEALTH MALAYSIA
Medical Device
Classification
Class Risk Level Device examples
A Low Simple surgical instruments, tongue depressor, liquid-in-glass
thermometer, examination light, simple wound dressing, oxygen
mask, stethoscopes, walking aids
B Low- Hypodermic needles, suction equipment, anesthetic breathing
Moderate circuits, aspirator, external bone growth simulators, hearing aids,
hydrogel dressings, patient controlled pain relief, phototherapy
unit, x-ray films
C High- Lung ventilator, orthopedic implants, baby incubator, blood
Moderate oxygenator, blood bag, contact lens disinfecting/cleaning products,
deep wound dressing, defibrillator, radiological therapy equipment,
ventilator
D High Pacemakers and their leads, implantable defibrillators, implantable
infusion pumps, heart valves, inter-uterine contraceptive devices,
neurological catheters, vascular prostheses, stents
DEVICE
Pre-market review contributes
to device quality, safety
& performance
REPRESENTATION
Placement-on-market control
Measures ensure correct
product representation
USE
Post-market surveillance ensures
device in use continues to be
safe and effective
Requirements
Systematic examination Procedures
established
of evidence generated undertaken by the
by the Regulatory
by the manufacturer manufacturer
Authority
applied to medical
devices is proportional to
the class of (or degree of
perceived risk associated
with) the device
submit
REGULATOR/CAB
Review submission
MANUFACTURER MARKET
NO YES
Conformity assessment of
quality management system:
• quality management system
• post-market surveillance system
REGISTRATION
Conformity assessment of
• Safe medical
MD safety and performance: devices
• summary of technical document
• Responsible
• declaration of conformity
establishments
Thank You