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