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

Medical Device Registration in Pakistan:

• 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