One Stop Shop for Licensing of Medical Devices (https:://e.dra.gov.pk/login)
|Reform Description||Process of Registration for Getting License for Import and Manufacturing of Medical Devices, from DRAP has been Fully Automated
Before: License application along with documents had to be physically submitted in DRAP’s Islamabad Office, causing delay and extra cost to business.
After: The Registration process has been simplified and automated. Applicants can now submit applications online from anywhere in Pakistan.
|Sector||Manufacturing (Medical Devices) / Importers|
|Beneficiaries||250+ Importers/Manufacturers registered with HDAP, whereas almost 1000+ are categorized as informal Importers/ Manufacturers|
|Jurisdiction/Location||Federal (Entire Pakistan)|
|Department||Drug Regulatory Authority of Pakistan (DRAP)|
|Date of Implementation||26-08-2021|
|Details||Difficulty||● All medical devices being imported or manufactured locally are required to be registered with DRAP. According to the World Health Organization (WHO), there are an estimated 2 million different kinds of medical devices in the world market, categorized into more than 7,000 generic devices groups. Due to the cumbersome and tedious registration process of the medical devices and limited evaluation resources, DRAP has only been able to register approximately 3,200+ medical devices till date.|
|Analysis||● BoI was approached by the Healthcare Devices Association of Pakistan (HDAP) for easing the registration process. Accordingly, BoI, after consultation with the relevant stakeholders, approached DRAP and proposed automation of the registration process.|
|Solution||● To ease the import and manufacturing of the medical devices, DRAP has developed an online system (MDMC Online System for processing of applications for establishment of license to import or manufacture medical devices.|
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