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Pakistan

Medical Device Registration in Pakistan

Ministry of Health:     

Ministry of National Health Services Regulation and Coordination

Regulatory Authority:          

Drug Regulatory Authority of Pakistan (DRAP)

Medical Device Regulation:          

No defined Medical Device Regulation

Official Language:      

Urdu, English

Classification:    

Class A, B, C and D

Registration Process:

  • Appoint an Authorized Representative
  • Submit an online application form for the Establishment License
  • Submit hardcopy of the application to Medical Devices Division, DRAP
  • The storage premises may be inspected
  • If approved, the Medical Device Board (MDB) grants Establishment License

Documents Required:          

  • Establishment License Application Form (Form 2)
  • Payment Receipt
  • Establishment Details
  • Technical Person details
  • List of medical device
  • Product Registration Dossier
  • Declaration
  • Undertaking
  • Readable softcopy

Applicable QMS:          

ISO 13485

Registration Timeline:         

Class A – 6-8 months

Others – 8-10 months

Authorized Representative:          

Yes

License Validity:          

5 years

Want to know more about this registration process?