Pakistan 2026 Regulatory Update on PSW and Digital Submission

1. Key takeaways

The main line of Pakistani device regulation from 2025 into 2026 is deepening digitalisation, with two clear institutional milestones. First, the e-DRAP / e-Service portal was launched on 21 July 2025 (inaugurated by the Prime Minister); new applications, renewals and changes for institutional licences and for product enlistment / registration are now submitted online, and paper submissions are no longer accepted. Second, a DRAP letter No. 6-14/2025DDQA(VII)-0002, signed on 16 October 2026 and published on 17 October 2026, requires import customs clearance to be submitted through PSW. Taken together, the two milestones close the paper era from both ends of the product journey: the front end, where applications enter the regulator, and the back end, where consignments enter the country. A company that has already adapted its submission practices but not its customs documentation — or the reverse — is only half digitalised, and the unadapted half is now the one that generates rejections at a counter or at a port. The chronological distance between the two milestones also matters: a company that planned its 2025 submissions around the portal but never revisited its customs procedure in 2026 has been caught by the second milestone with no run-up at all.

2. Legal basis

The sequence of instruments leading to the current digital position is set out below in chronological order. Reading the timeline as a whole makes the direction of travel unmistakable: amendments accumulate, fees are revised, and then the submission and clearance channels themselves are moved online.

3. Expert insights

Insight one: the two digital actions differ in nature. The portal launch solves how applications are submitted, while the PSW letter solves how consignments clear customs. The former belongs to the registration stage and the latter to the trade stage, yet many companies conflate the two, complete their registration work, and then find the import operation still running the old process. The confusion is understandable because both changes carry the DRAP name and both arrived recently. But the audiences, the documents and the failure modes are entirely different: a missed portal change produces a rejected application, while a missed PSW change produces a container stopped at the border. Treating them as one project with two deliverables, each with its own owner, prevents exactly that drift, and it forces the customs team into the regulatory planning conversation where it belongs.

Insight two: applications filed in the old system do not migrate automatically. At the time the portal launched, applications previously submitted through the old MDMC channel continued to be processed in the existing channel and were not automatically moved into the portal. This means two channels, old and new, have been running in parallel. On projects, GRZAN first confirms which channel a client’s application sits in before deciding on the response strategy for corrections, because the two channels may differ in interface, in status visibility and in the practical turnaround a submitter can expect. Assuming that everything has converged onto the portal risks sending a correction through the wrong door and waiting for an answer that was never triggered.

Insight three: the PSW letter rests on the premise of complete data. The letter also requires importers to complete the update of their system data, covering both the institutional licence and the product enlistment / registration information. Where the data update has not been completed, goods may not move smoothly through PSW even though a valid certificate exists. The certificate and the system record are no longer independent: the digital clearance chain reads the system, so the system must be as current as the paper. This quietly converts data hygiene from an administrative chore into a customs-critical control, and it should be resourced accordingly. The check is simple to build: before each shipment, confirm that the system record matches the certificate, the licence and the invoice, because PSW will read whatever the system holds.

4. Practical recommendations

In the face of frequent revisions, GRZAN’s execution principle is a single one: every external document is marked with its reference number and verification date, and the current version is re-verified once before a project starts. In the delivery package that GRZAN provides to clients on Pakistan projects, a rules version comparison table is always attached — listing, for each cited basis, the full title of the document, the reference number, the effective date and the verification date, so that any statement can be re-checked at any time. The practice sounds bureaucratic until the first time an S.R.O. changes mid-project: with the comparison table, updating the affected documents is an afternoon of work; without it, it is an archaeology exercise across months of correspondence. Version discipline is what turns a volatile regulatory environment into a manageable one.

5. Verification checklist

• □ All applications have been confirmed for submission through the e-Services portal (from 2025-07-21)
• □ The channel and processing status of applications in the old system have been confirmed
• □ The institutional licence data in the system has been updated
• □ The product enlistment / registration data in the system has been updated
• □ The import customs clearance process has been scheduled through the PSW channel
• □ Reference numbers and verification dates have been marked in the delivery documents

Regulatory information verified as of October 28, 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