Pakistan’s Drug Regulatory Authority (DRAP) launched an online licensing and registration system for medical devices on 21 July 2025. It is intended to replace parts of a paper-heavy application process with online submissions, status tracking and digital correspondence. The Federal Health Ministry reported that medical-device licences that had taken 18–24 months were being issued in about 20 days through the digital process; that is an official early result, not an independently audited service-wide average.
What DRAP’s new system does
The Medical Devices and Medicated Cosmetics (MDMC) portal gives manufacturers and importers an online route to submit applications and supporting documents, follow application progress, correct common errors and communicate with DRAP through structured workflows. The authority’s training notice describes guidance on submitting documents, tracking applications and avoiding common mistakes, as well as live question-and-answer support.
The stated administrative aim is to reduce manual handling and the need for applicants to visit DRAP offices. For businesses, the practical change is a more traceable application channel; it does not by itself establish that every application will be processed within a particular timeframe or receive approval.
What the reported speed and early figures show
At the system’s launch, the Federal Health Ministry contrasted the previous reported medical-device licensing timeline of 18–24 months with licences issued in about 20 days through the digital process. The ministry and DRAP presented this as an early improvement. The available official figures do not specify a measurement method, a comparison cohort, or whether the reported 20 days applies to all application types, so it should not be read as a guaranteed turnaround.
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A Pakistan Press Information Department review dated 25 August 2025 reported 940 applications received since launch and 188 approvals issued with digital letters. It itemized 798 applications across six categories:
| Application category | Reported applications |
|---|---|
| Registration applications | 610 |
| Post-registration variations | 53 |
| Product renewals | 75 |
| New licensing applications | 31 |
| Post-licensing variations | 7 |
| Licence renewals | 22 |
The six listed categories total 798, fewer than the reported 940 applications; the review did not classify the remaining 142 in the figures provided. The approvals count is not broken down by category, nor does it show how many applications were still pending or rejected.
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The same review said the management dashboard had expanded from 10 to 23 parameters within one month. Officials described the expanded monitoring as a way to strengthen oversight, but the reported parameter count alone does not establish better compliance outcomes.
How this fits DRAP’s wider digitization
The medical-device portal is part of a broader effort to move regulatory processes online, rather than DRAP’s first digital application channel. On 6 December 2023, Pakistan launched an online application for drug registration and licensing. The government said pharmaceutical companies and new multinational applicants could submit drug-registration and licensing applications online instead of visiting DRAP. DRAP’s Pharmaceutical Inspection and Regulatory Information Management System (PIRIMS) notice describes electronic processing for pharmaceutical and biological licensing, registration and inspections.
A National Assembly document in 2026 said applications for pharmaceuticals, biological drugs and medical devices had reached 100% digitization, while 80% of regulatory functions were digitized end to end. It said the remaining functions were scheduled for completion by 31 December 2026. Digitizing an application is not the same as digitizing every step of its review, which is why the document distinguishes application coverage from end-to-end regulatory functions.
What changes for applicants—and what it does not prove
DRAP’s stated design shifts the applicant experience from office visits and manual status inquiries toward online submission, tracking, structured communication and electronic records. Those features can make the progress of an application easier to follow and create a more consistent record of exchanges. Whether they reduce delays or administrative burden across all applicant types requires broader outcome data than the launch and early-use figures provide.
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Federal Health Minister Mustafa Kamal described the shift in July 2025 as “a significant move toward modernizing our regulatory framework.” The government’s stated goal is timely access to quality and safe medicines. Neither that objective nor the portal’s monitoring features demonstrate, on their own, improved approval quality, fewer counterfeit medicines, better patient outcomes or long-term export growth. The cited official material does not provide an independent evaluation of those effects.
For manufacturers, importers and regulatory-affairs teams, the immediate practical step is to use DRAP’s portal guidance and support for the applicable application workflow, and to retain the digital correspondence and submission records. The training notice identifies manufacturers and importers as intended users and covers common submission errors; it does not set out a universal checklist of documents for every application type.
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The separate role of medicine track-and-trace
Pakistan’s 2026 cabinet-approved track-and-trace program is a related but distinct digital initiative. It calls for standardized 2D barcodes and serialization so medicines can be checked through the supply chain, with DRAP overseeing nationwide rollout. That supply-chain system is not the same as the MDMC portal: licensing and registration manage regulatory applications, while track-and-trace is intended to support product identification and movement checks.
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