Pakistan’s Drug Regulatory Authority (DRAP) inaugurated its medical-device licensing and registration portal on 21 July 2025. It moves applications and supporting documents online, adds application tracking and structured communications, and is intended to reduce paper handling and office visits. The Federal Health Ministry said medical-device licences that had previously taken 18–24 months were being issued within 20 days, but that reported figure is not an independently verified average or a guarantee for every application.
What DRAP launched, and how it fits with earlier online services
The July 2025 launch was specifically for medical-device licensing and registration. The portal, referred to in DRAP training material as the MDMC portal, gives manufacturers and importers a digital route to submit applications and documents, follow application progress, correct common errors, and communicate with DRAP through structured workflows and expert support.
It was not Pakistan’s first online regulatory service. On 6 December 2023, the government announced an online application system for drug registration and licensing. DRAP’s PIRIMS notice describes electronic processing for pharmaceutical and biological licensing, registration, and inspections. The systems therefore form part of a broader digitization effort, but the 2023 drug service and the 2025 medical-device portal are not the same launch.
What applicants can do through the medical-device portal
DRAP’s training notice describes guidance for manufacturers and importers on portal use, document submission, application tracking, avoiding common errors, and live question-and-answer support. The practical change is that applicants can submit and manage work online rather than relying solely on paper submissions, in-person visits, and manual status inquiries.
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That can make the status of an application more visible and give both the applicant and regulator an electronic record of submissions and communications. It does not mean that every review step is automated, that an application will be approved, or that the portal removes the need to meet DRAP’s substantive requirements.
How much faster is licensing, according to officials?
At the July 2025 launch, the Federal Health Ministry reported that medical-device licensing had previously taken 18–24 months and that licences were being issued within 20 days through the digital process. Those figures are an official comparison, not a published independent time study: the cited announcement does not establish the number or type of cases behind the 20-day figure, whether it is an average, or whether the timing applies to every application. Applicants should treat it as a reported early result, not a service-level guarantee.
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DRAP’s early activity figures provide a separate snapshot. By the review dated 25 August 2025, the Pakistan Press Information Department reported 940 applications since launch and 188 approvals issued with digital letters. The listed application categories were:
| Application category | Count reported by 25 August 2025 |
|---|---|
| Registration applications | 610 |
| Post-registration variations | 53 |
| Product renewals | 75 |
| New licensing applications | 31 |
| Post-licensing variations | 7 |
| Licence renewals | 22 |
| Other applications in the reported total | 142; not itemized in the announcement |
| Total applications recorded | 940 |
| Approvals issued with digital letters | 188 |
The 142 figure is the difference between the reported total and the six itemized categories; the announcement did not identify those applications by category. The 188 digital-letter approvals are a count, not an approval rate: the announcement does not specify how many applications had completed review or were eligible for a decision by that date.
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How the workflow compares with the previous approach
| Area | Earlier approach described in official material | Digital approach described in official material |
|---|---|---|
| Processing time | 18–24 months, as reported by the Federal Health Ministry in 2025 for medical-device licensing | Licences within 20 days, as reported by the Federal Health Ministry in 2025; the announcement does not define the case mix or whether this is an average |
| Submitting applications | Paper handling and office visits were part of the earlier administrative burden described by officials | Online application and document submission through the medical-device portal |
| Following progress | Manual status inquiries, as contrasted in the official workflow description | Application tracking and structured communications |
| Regulatory scope | The online drug registration and licensing application launched in December 2023; DRAP also describes electronic pharmaceutical and biological workflows through PIRIMS | The July 2025 portal adds a digital route for medical-device licensing and registration |
| Oversight and records | Manual handling is the administrative process the reform is designed to reduce | Electronic application records; DRAP officials also reported expanding the management dashboard from 10 to 23 parameters within one month of launch |
The dashboard change was described by officials as a way to support closer oversight. The announced increase in parameters does not, by itself, show that decisions became more accurate or that delays were eliminated.
How far DRAP’s digitization has reached
A 2026 National Assembly document says applications for pharmaceuticals, biological drugs, and medical devices had reached 100% digitization, while 80% of all regulatory functions were digitized end to end. The distinction matters: an application may be submitted digitally even when some internal regulatory steps are not yet fully digital. The document said the remaining functions were scheduled for completion by 31 December 2026; as of October 2026, that date is still ahead, and the stated schedule is not confirmation that the work has been completed.
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What the change may mean for healthcare regulation—and what it does not prove
Online submission, tracking, structured communication, and electronic records can make regulatory processes easier to monitor and reduce administrative friction. Those are plausible administrative benefits and stated aims of the reform. The available official announcements do not establish that digitization has independently reduced counterfeit medicines, improved the quality of regulatory decisions, changed patient outcomes, or driven long-term export growth.
The government’s 2026 cabinet-approved track-and-trace program is a separate digital layer. It calls for standardized 2D barcodes and serialization, with DRAP overseeing a nationwide rollout so medicines can be checked through the supply chain. That supply-chain initiative should not be confused with the application portal: licensing and registration concern regulatory applications, while track-and-trace is intended to identify and follow medicine packs.
Who should use the portal and where to get help
The immediate users are medical-device manufacturers and importers, along with the regulatory-affairs teams that prepare and manage their submissions. DRAP’s Karachi orientation material directs manufacturers and importers to portal guidance and support. The same material frames the change as a shift in how regulation is carried out, not merely a new software interface.
Pharmaceutical and biological-product applicants should distinguish their existing online workflows from the medical-device portal and use the relevant DRAP system and guidance for their application type. The official launch material describes the portal’s functions and training, but the announcements cited here do not set out a universal list of required documents, eligibility rules, or a guaranteed decision time for every product category.
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