ISLAMABAD, Oct. 18 (Focus Pakistan) - Medical device imports face tighter clearance rules as Pakistan's drug regulator (DRAP) restricts access to its older approval system. Importers who can use Pakistan Single Window (PSW) must now submit applications through that platform, while companies facing licensing or registration data problems may temporarily continue using the legacy system.
The Drug Regulatory Authority of Pakistan (DRAP) issued the instruction in a notice dated Oct. 16, titled “Development of Medical Devices Module on PSW.”
Under the notice, importers who can access PSW must submit their medical device import applications through that platform. The regulator’s older Online Import and Export System (OIES) remains available on an interim basis. Only importers who cannot use PSW because their establishment licence or device registration data is not up to date may use it.
DRAP told all importers to complete their establishment licences and medical device registration records quickly so they can move to PSW for good.
A NARROWING EXCEPTION
The order does not launch PSW for medical devices; that migration was already under way. What changes is the status of OIES, which shifts from a parallel option to a fallback for firms with data problems.
The notice sets no final date for switching OIES off. It announces no new fee, no penalty and no import restriction.
The practical effect falls on records. Under the Medical Devices Rules, 2017, importers need an establishment licence from DRAP, and imported devices need registration. If either record sits incomplete on DRAP’s side, the firm stays tied to the old system. Firms with clean records have no further choice: they file through PSW.
DRAP and PSW signed a memorandum of understanding in November 2022 to move the regulator’s cross-border trade processes onto the single window. PSW began offering digital drug import licences in January 2024. DRAP later switched clearance of commercial imports of raw materials and finished drugs from OIES to PSW.
Medical devices now follow the same path. PSW lets traders submit documents once through a single entry point and track applications online, instead of chasing files in person.
WHY IT MATTERS
Pakistan relies heavily on foreign suppliers for medical technology. Switzerland Global Enterprise and the Swiss Business Council in Karachi published a fact sheet on April 28 that values the country’s MedTech market at $500 million to $600 million. It says more than 90% of medical devices come from abroad.
That dependence makes DRAP’s clearance step a routine checkpoint for hospital suppliers, diagnostic laboratories and distributors, covering everything from syringes to imaging equipment. Any delay in updating an importer’s records could keep that firm on a system the regulator now treats as temporary.
DRAP has not said how long the OIES exception will last. Nor has it said how many importers still have incomplete licence or registration data.
Importers now face a simple test. Firms whose records are complete belong on PSW today. The rest have a window of unknown length to fix their files before DRAP further restricts the old system.
