Pakistan DRAP Directs Device Imports to PSW

Regulatory Update

On 17 October 2026, the Drug Regulatory Authority of Pakistan (DRAP) published Development of Medical Devices Module on PSW, attaching Letter No. 6-14/2025DDQA(VII)-0002 dated 16 October 2026. Signed by Ishtaiq Shafiq, Deputy Director-IV (QA), with the approval of the CEO of DRAP, and addressed to the Healthcare Devices Association of Pakistan (HDAP) and the Pakistan Electro Medical Devices Association (PEMDA) — with copies to DRAP's Directors of QA & LT, MDMC, and MIS as well as the Import & Export Offices in Karachi, Lahore, Islamabad, and Peshawar — the letter defines when medical-device importers must file import clearance applications in the Pakistan Single Window (PSW) system and when they may temporarily continue using the Online Import & Export System (OIES).

The 16 October 2026 letter states that it continues an earlier DRAP letter of the same reference number dated 17 July 2026 regarding the integration of the DRAP Medical Devices Licensing and Registration System with PSW. That earlier 17 July 2026 letter is not posted on DRAP's public medical-devices news index and was not opened.

Transitional Routing Rule Between PSW and OIES

The five paragraphs of the 16 October 2026 letter establish the following operational rules:

What the Letter Does Not Change

• No calendar sunset date on the face of the letter: Although Paragraph 4 describes a "smooth and permanent switchover to the PSW system," the 16 October 2026 letter does not announce a specific date on which OIES will be switched off.
• No change to underlying licensing or registration standards: The letter governs the electronic portal used for import clearance and the synchronization of existing establishment licence and device registration data between DRAP's licensing/registration system and PSW. It does not alter substantive medical-device classification, establishment licensing criteria, or product registration fees in Pakistan.

Practical Implications for Manufacturers and Importers

Pure Global analysis:

• Default to PSW for Pakistan medical-device shipments: Importers and authorized representatives managing Pakistan medical device market access should treat PSW as the mandatory default channel for import clearance applications whenever their establishment licence and product registration records have synchronized cleanly. OIES is no longer an open alternative of convenience.
• Audit both establishment licence and device registration records in DRAP's system: Because PSW clearance pulls directly from the DRAP Medical Devices Licensing and Registration System, importers should verify that both their establishment licence number/validity and each product's registration details are fully updated in DRAP's database before consignments ship.
• Retain evidence if relying on the OIES fallback: If an importer must file through OIES during the transitional period, it should document that the filing falls within Paragraph 2's specific exception — inability to access or utilize PSW due to pending data-updating issues in DRAP's system — and complete those data updates promptly rather than waiting for DRAP to announce a final OIES shutoff date.