Eliminate License to manufacture Medical Devices and adopt a risk based approach
Reform IDF598
DescriptionBefore: Under the Medical Devices Rules, 20178The License to Manufacture Medical Devices (also known as the Establishment License) is a formal authorization issued by the Medical Device Board (MDB) of the Drug Regulatory Authority of Pakistan (DRAP). The license is required for businesses engaged in the manufacture, import, export, storage, distribution, or sale of medical devices in Pakistan.9. Each premises must obtain a separate license, and licenses are valid for five years, unless suspended or cancelled. Separate establishment licences for each premises, extensive documentation, and regulatory approval requirements increase compliance costs and delay the manufacturing and distribution of medical devices.
DepartmentDrug Regulatory Authority of Pakistan - DRAP
Jurisdiction / LocationFederal - Entire Pakistan
SectorAll Sectors
Start Date04-02-2026
Target Deadline
Date Enacted
Implementation StatusIn Progress
Progress 0%
CCORR Direction
Cost Savings PKR (Mil.)
Evidence