Pakistan Import Permits, Import NOC and PSW Clearance for Medical Devices

1. Key takeaways

Importing devices into Pakistan is a “documents + channel” two-layer structure: the document layer is the Import Permit and the per-shipment import No Objection Certificate (Import NOC); the channel layer is the Pakistan Single Window (PSW). According to DRAP letter No. 6-14/2025DDQA(VII)-0002, issued on 16 October 2026 and published on 17 October (signed by the Deputy Director of the QA Division, Ishtaiq Shafiq, endorsed by the DRAP Chief Executive Officer, and addressed to HDAP and PEMDA): importers who are recordable in PSW must submit through PSW; OIES is open only during the transition period to applicants who cannot use PSW because of data update issues.

The structural point behind the letter is that importation now runs on two tracks at once: the regulatory track, where permits and NOCs are granted, and the customs channel, where the declarations physically move. Aligning the two tracks is an operational task. An importer whose permit file is perfect but whose PSW and DRAP system records are stale will still watch a consignment stop at the port, because the channel layer cannot see what the document layer does not show. The practical remedy is to treat the system record as a living compliance object with its own maintenance schedule, refreshed at every certificate event, rather than as a one-time registration formality.

2. Legal basis

The table below sets out the sources governing who may import, under what permit, through which channel, and with what data obligations.

Note that the letter is an administrative instruction about channels and data rather than a new fee or a new permit: the underlying permits and their fees remain governed by the Medical Devices Rules, 2017 and Schedule C, while the letter determines where and how the import process is executed. For planning purposes the letter should be read alongside the permit provisions: the permit answers the regulatory question of eligibility, and the letter answers the operational question of routing and data readiness.

3. Expert insights

Insight 1: the point of this letter is not the system change but data completeness. The letter also requires all importers to complete the data updates in the DRAP device licensing and registration system, including the establishment licence and product enlistment/registration information. This means that even when product registration is finished, importation still cannot proceed if the data in the system has not been synchronised. The regulator’s view has shifted from paper certificates to system records, and the system is now the operative truth at the port. Importers should audit their own records in the DRAP system the way they audit their certificates, because a mismatch between the two is no longer a clerical detail but a blocker. A quarterly self-check against the system record is proportionate to the risk and can be delegated to a single named owner once the routine is set up.

Insight 2: the text of the letter sets no explicit deadline for the transition period. We confirmed this point specifically during verification — the body of the letter does not state a specific sunset date for the transition. In practice, preparations should follow the logic of “PSW as the main channel, OIES as the exception”, and the data updates should be completed as soon as possible rather than relying on the transitional arrangement. An undefined transition is, in operational terms, a transition that can close at any time, and building a supply plan on the continued availability of the exception would be imprudent.

Insight 3: the import permit is a standing 5-year document, while the NOC is per-shipment. The two are not substitutes: the permit answers whether importation is possible in general, and the NOC answers whether this particular shipment can enter. Production and shipping plans should be paced around the NOC processing rhythm, not the permit validity period. Because the NOC operates at the level of each consignment, its document set travels with the shipment and must match the invoice, packing list, and certificate exactly, which is why the reconciliation work belongs before departure rather than at the port. Each NOC cycle should also feed its own lessons back into the timetable, since actual processing times observed over successive shipments are the best basis for planning the next ones.

4. Practical recommendations

What GRZAN delivers at the import stage is an “import three-piece set”: an import permit status table (document number, validity, coverage), a product-and-system data consistency check table (comparing the portal records against the certificates item by item), and a per-shipment NOC processing timetable. We particularly stress that the data reconciliation must be completed before the first shipment — once this kind of problem is exposed at the port, what is lost is the demurrage cost of an entire container. The three-piece set is deliberately simple enough to be maintained by the client’s own team after handover, and we recommend refreshing the consistency check table every time a certificate is renewed, varied, or newly issued, so that the system records never drift away from the paper file. The three documents together also shorten the conversation with any freight forwarder or customs broker, because every question the broker asks is answered by one of the three tables.

5. Verification checklist

• □ Valid import permit held (validity of 5 years)
• □ Establishment licence information updated in the DRAP device licensing and registration system
• □ Product enlistment/registration information updated in the system
• □ Confirmed that the importer is recordable in PSW
• □ Import NOC processing scheduled by shipment
• □ Arrival notification (Form-11) and other clearance materials prepared

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