Pakistan MDMC e-Service Portal: Mandatory Online Submission Since July 2025

1. Key takeaways

On 21 July 2025 DRAP launched its digital system for medical devices — the MDMC licensing and registration online portal (the e-Service portal, with the official entry point at e.dra.gov.pk and the backup entry point at edrap.dra.gov.pk). From that date, new applications and renewals for the Establishment Licence, new applications and renewals for product enlistment / registration, and post-enlistment / post-licence variation applications must all be submitted through the portal; paper submissions are no longer accepted. Every procedural step that used to be handled offline — filing, fee confirmation, deficiency responses and status tracking — now lives inside one digital channel.

• The MDMC licensing and registration portal became the sole submission channel for the four categories of applications from 21 July 2025.
• The official entry point is e.dra.gov.pk, with edrap.dra.gov.pk as the backup; both should be tested before a filing day.
• Official operating data reported 940 applications received cumulatively, of which 188 had been approved with digital letters issued, as of 25 August 2025.
• Licence issuance time after digitalisation is reported at about 20 days, compared with 18–24 months previously — a comparison that must be quoted precisely to clients.
• The portal is also the channel for deficiency letters and their responses, so monitoring must be continuous after submission.

2. Legal basis

The mandatory-online regime does not rest on a single rule number but on DRAP’s official announcements of July 2025 and the publicly reported operating data that followed. The table below consolidates the announcement dates, entry points, the four application categories and the reported performance figures, with the source given for each.

3. Expert insights

Insight one: the portal launch removed physical submission from the process entirely. Previously, paper dossiers, courier parcels and email attachments could all serve as submission channels; now only a portal entry counts as a submission. This is the largest single procedural change in Pakistani device regulation in roughly a decade. Teams with habits built around printing, stamping and couriering need to retrain deliberately, because muscle memory from the paper era produces exactly the kind of off-portal action that now has no regulatory effect at all. The transition also changes evidence management: every proof of what was filed, when, and with what attachments now exists in portal form, which makes the internal ledger described below not a convenience but the company’s primary record of its own regulatory position.

Insight two: digitalisation did shorten timelines, but what shortened is the licensing / enlistment step. The official figure is licence issuance in about 20 days (against 18–24 months previously). This does not mean product registration completes in 20 days — technical review and deficiency round-trips still consume time, and each round-trip runs at the pace of both the reviewer and the responding company. GRZAN is careful to keep these two measures strictly separated in client communication, because conflating a licensing turnaround figure with an end-to-end registration timeline is the fastest way to create expectations that the process cannot meet and that no statistic in the public record supports.

Insight three: the portal is simultaneously the channel for deficiency notices and status enquiries. When the technical team identifies a problem it issues an online Deficiency Letter through the portal, and the company’s response must also be completed inside the portal. This means the local partner must stay online and monitor continuously, rather than filing and waiting for a letter. A deficiency response that arrives after its window closes carries the same consequences as one never written, so the operating model around the portal matters as much as the dossier itself. In a digital system there is no postal delay to hide behind: the moment a notice issues, the clock is visible, and a partner who checks the portal weekly has already conceded most of the response window before the work begins.

4. Practical recommendations

GRZAN requires local partners to maintain an internal ledger on the portal: application number, payment receipt, upload list, deficiency letter dates, response deadlines and current status.

• Build the internal ledger around the fields that drive deadlines: application number, payment receipt number, upload list, deficiency letter dates, response deadlines and current status.
• Synchronise status to the client once a week, so portfolio decisions are made on current information rather than stale recollection.
• Provide a response plan within 48 hours of any deficiency letter arriving, keeping the response clock ahead of the portal clock.
• Require the client team to complete the portal training materials provided by DRAP before the first submission — most deficiency letters stem from formatting and naming errors, not technical deficiencies.
• Verify both portal entry points (official and backup) are reachable before scheduling a filing day, so a single point of failure does not consume the calendar.

5. Verification checklist

• □ Confirmed the submission channel is the e-Service portal (not paper)
• □ The DRAP portal training materials have been studied
• □ The application number and payment receipt number have been obtained
• □ An internal portal ledger has been established and is updated weekly
• □ A response mechanism has been set for deficiency letters (within 48 hours)
• □ The team is aware that renewals must also be handled online

Regulatory information verified as of 28 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across South Asia, including Pakistan. Our team prepares dossiers to DRAP expectations, manages eCTD-format submissions and deficiency responses, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com