The Drug Regulatory Authority of Pakistan (DRAP) regulates Medical Devices in Pakistan.
Medical Device Definition
Medical devices include any instrument, apparatus, implement, machine, appliance, implant, reagent for in-vitro use, software, material or another similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings or animals for one or more of the specific medical purposes of:
And does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human or animal body, but which may be assisted in its intended function by such means.
- Diagnosis, prevention, monitoring, treatment or alleviation of disease.
- Diagnosis, monitoring, treatment, alleviation of or compensation for an injury.
- Investigation, replacement, modification or support of the anatomy or of a physiological process.
- Supporting or sustaining life.
- Control of conception.
- Disinfection of medical devices; or
- Providing information by means of in-vitro examination of specimens derived from the human body.
Medical Device Classification System
||Tongue depressors/ disposable masks
||Hypodermic Needles / suction equipment
||High- Moderate risk
||Lung ventilator / bone fixation plate
||Heart valves / implantable defibrillator
||6 to 9 months approximate
|License validity period
||Class A :- $18, Class B :- $89, Class C :- $178, Class D:- $178