Guides · DRAP
A DRAP import NOC covers one shipment. An establishment licence covers the business.
Shafiq Traders · Updated 14 September 2026
DRAP is the Drug Regulatory Authority of Pakistan, and its remit is therapeutic goods: drugs, medical devices, and medicated cosmetics, shampoos and soaps. An ordinary cosmetic with no medicinal claim on the label answers to the Pakistan Standards and Quality Control Authority, not DRAP. An establishment licence and an import NOC are not the same document. The establishment licence is what lets a company import medical devices as a business, against a catalogue of devices registered or enlisted with DRAP, and it runs five years before it needs renewing. The NOC is a one-off permission for a single consignment of a device that is not registered or enlisted — a hospital bringing in equipment it needs now, a donation, a personal-use item, a trial quantity. Apply for that NOC before the goods ship. Apply after, and the consignment reaches the port with nothing yet on file to release it against.
What DRAP controls, and the two documents it issues
DRAP's jurisdiction is therapeutic goods: drugs, medical devices, and medicated cosmetics, shampoos and soaps. Ordinary cosmetics and toiletries with no medicinal claim are PSQCA's business, not DRAP's — a shampoo becomes DRAP's problem the moment the label says it treats something.
Within medical devices, DRAP issues two different permissions and does not treat them as interchangeable. An establishment licence authorises a company to import or manufacture medical devices as an ongoing business, tied to the devices that company has registered or enlisted with DRAP. An import NOC — DRAP calls it a special permission — authorises one consignment of a device that sits outside that registered catalogue: unregistered equipment a hospital or institution needs directly, a donation from a government or NGO source, a personal-use item, or a small quantity brought in for test, trial or analysis.
A device already registered or enlisted under somebody's establishment licence does not need a fresh NOC every time it ships. The NOC exists for the goods that route works around, not the goods it covers.
Establishment licence against import NOC
| Establishment licence | Import NOC | |
|---|---|---|
| Who holds it | The importer or manufacturer, as a company | Whoever is bringing in that one consignment — a hospital, an institution, a donor, an individual |
| What it authorises | Importing medical devices as a business, against a catalogue registered or enlisted with DRAP | One specific consignment of a device outside that registered catalogue |
| How long it runs | Five years, unless revoked or suspended earlier | That shipment only — a new application for the next one |
| Typical holder | A distributor or manufacturer with a standing catalogue of devices | A hospital buying equipment it needs now, a donation programme, a personal import, a trial quantity |
Applying for an import NOC, in order
The declaration cannot be built around an application that is still sitting with DRAP.
File the special permission application with DRAP
Through DRAP's Personal Use online service for an individual, or direct with the Medical Devices Division for a hospital or institution, naming the device, the quantity and why it falls outside the registered route.
Supply what a registration would otherwise have supplied
Since the device is not registered or enlisted, DRAP wants the manufacturer's documentation and specification in the application itself, not referenced against a file it already holds.
Wait for DRAP's decision
The Medical Devices Division reviews the application on its own timeline. A personal-use NOC carries no fee under DRAP's current schedule; an institutional application can.
File the Goods Declaration once the NOC is issued
The declaration references the NOC the way a routine import references the device's registration. There is nothing to reference until DRAP has decided.
What is actually on the Pakistan Single Window, and what is not
Reports through 2026 describe medical device import NOCs moving onto the Pakistan Single Window. Checked against DRAP's own site, that had not happened as this page was written. What has moved to PSW is drugs — import licences, clearance certificates for raw materials and finished medicines, release orders for donated medicines — and only at Karachi's seaport and airport customs stations.
Medical device establishment licence and NOC applications still go through DRAP's own portal, the Digital System for Licensing & Registration of Medical Devices, which the Prime Minister opened in Islamabad in mid-2025. If somebody tells you a device NOC files on PSW today, check DRAP's site yourself before booking the shipment against it.
Where the file actually stalls
A registered device moves like any other import: the declaration references the establishment licence and the device's own registration, and customs assesses it on that basis. An NOC consignment has nothing to reference until DRAP has ruled on the application.
That is the point a shipment stalls. If the NOC application goes in after the container is loaded, the goods reach the port before the decision does, and the declaration cannot be finished around a file that is still open. The goods sit in the terminal, accruing storage, while the application works through DRAP's queue on its own schedule — a schedule the ship's arrival does not move.
What a personal-use NOC actually costs
One category is free under DRAP's own fee schedule. An institutional application is not automatically the same.
- Personal-use import or export NOCNo feeon Filed through DRAP's Personal Use online service · DRAP Schedule of Regulatory Fees
Checked 14 September 2026 against Drug Regulatory Authority of Pakistan — Regulatory Fees. Rates move at the budget and by SRO in between, so confirm the current figure with us before you price a consignment on it.
We cannot get DRAP to open your NOC file sooner because the container is already loaded. That decision moves at DRAP's pace, not the ship's, and an application filed after the goods sail reaches the port with nothing to show for it. If your device is not registered or enlisted and the NOC has not gone in yet, we will tell you before you book the shipment, not after it is sitting in the terminal.
Questions
What importers ask about the DRAP import NOC
Contact
Tell us what is coming.
Give us the product, the port and roughly when the vessel is due, and we will tell you what the clearance involves and what it will cost.
Related
Sources
- Drug Regulatory Authority of Pakistan — Special Permissions
- Drug Regulatory Authority of Pakistan — Medical Devices Establishment Licenses
- Drug Regulatory Authority of Pakistan — Medical Devices Application Process
- Drug Regulatory Authority of Pakistan — Authorized Products
- Drug Regulatory Authority of Pakistan — Organization Divisions
- Drug Regulatory Authority of Pakistan — Switched Over to Pakistan Single Window at Karachi Customs Stations
- Drug Regulatory Authority of Pakistan — Inauguration of the Online System for Medical Device Applications
- Drug Regulatory Authority of Pakistan — Regulatory Fees
- Pakistan Single Window — DRAP