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Pakistan Medical Device Regulations

Agency
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:
  1. Diagnosis, prevention, monitoring, treatment or alleviation of disease.
  2. Diagnosis, monitoring, treatment, alleviation of or compensation for an injury.
  3. Investigation, replacement, modification or support of the anatomy or of a physiological process.
  4. Supporting or sustaining life.
  5. Control of conception.
  6. Disinfection of medical devices; or
  7. 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.
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
Approval Process
Classification Approval procedure
Class A
  • Classification of the Medical Device according to the rules set by DRAP.
  • In order to register an imported medical device in the country, the importer must first obtain an Establishment License to import medical devices from Medical Devices Division of DRAP.
  • Completion of the requirement by the applicant.
  • Submit the dossier in the format specified by the application form as hard copies and softcopy in USB/CD.
  • Include the application fee.
  • Once the technical and clinical evaluations are complete, DRAP will make a decision on whether to grant the registration certificate.
Class B
Class C
Class D
Additional Information
Approval timeline 6 to 9 months approximate
License validity period 5 Years
Fees Class A :- $18, Class B :- $89, Class C :- $178, Class D:- $178
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