Eliminate Export Permit for Establishment (Form 12) and adopt a risk based approach
Reform IDF602
DescriptionBefore: Under the Medical Devices Rules, 201720The Export Permit is a formal authorization issued by the Medical Device Board (MDB) of the Drug Regulatory Authority of Pakistan (DRAP). The Rules stipulate that no establishment may export a medical device without the approval of MDB or an officer authorized for this purpose.21 The permit is issued at the establishment level. Mandatory establishment-level export permits, documentation requirements, and regulatory approvals increase compliance costs and delay the export of medical devices.
DepartmentDrug Regulatory Authority of Pakistan - DRAP
Jurisdiction / LocationFederal - Entire Pakistan
SectorManufacturing and Importing - Medical Devices
Start Date04-02-2026
Target Deadline
Date Enacted
Implementation StatusIn Progress
Progress 0%
CCORR Direction
Cost Savings PKR (Mil.)
Evidence