Pakistan Medical Device Regulations
Regulatory Agency
The Drug Regulatory Authority of Pakistan (DRAP) regulates Medical Devices in Pakistan.
Medical Device Definition
Medical devices: 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:
- 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. 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
Active device intended for diagnosis: means any active medical device, whether used alone or in combination with other medical devices, to supply information for detecting, diagnosing or monitoring or to support the treatment of treating physiological conditions, states of health, illnesses or congenital deformities.
Active medical device: means any medical device, the operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy but does not include medical devices intended to transmit energy, substances or other elements between an active medical device and the patient without any significant change.
Active therapeutic device: means any active medical device, whether used alone or in combination with other medical devices, to support, modify, replace, or restore biological functions or structures with a view to treat or alleviate an illness, injury, or handicapness.
Medical Device Classification System
| Classification | Risk Level | Examples |
|---|---|---|
| Class A | Low risk | Tongue depressors/ disposable masks |
| Class B | Low–moderate risk | Hypodermic Needles / suction equipment |
| Class C | High- Moderate risk | Lung ventilator / bone fixation plate |
| Class D | High risk | Heart valves / implantable defibrillator |
Regulatory Approval Process
Classification |
Approval procedure |
|---|---|
Class A
Class B
Class C
Class D |
|
Additional Information
Approval timeline |
180 days |
License validity period |
5 Years |
Fees |
Class A : $21, Class B : $111, Class C : $222, Class D: $222 |
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