Eliminate Certificate of Enlistment/Registration of Medical device and adopt a risk based approach
Reform IDF599
DescriptionBefore: Under the Medical Devices Rules, 2017, The Certificate of Enlistment of a Medical Device is a formal authorization issued by the Medical Device Board (MDB) of the Drug Regulatory Authority of Pakistan (DRAP). The Certificate of Enlistment (also referred to as the Certificate of Registration) serves as a requisite for the manufacturing, importation, and marketing of medical devices in Pakistan. Mandatory enlistment of medical devices, extensive documentation, and regulatory review requirements increase compliance costs and delay the manufacturing, import, and marketing 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