Medical Device Registration with DRAP: What Importers Need to Know

Who regulates medical devices in Pakistan

The Drug Regulatory Authority of Pakistan (DRAP) is the national regulator. Within DRAP, the Medical Device Board is responsible for registering and enlisting medical devices and for licensing importers and local manufacturers under the Medical Device Rules, 2017.

DRAP publishes provisional lists of registered and enlisted devices alongside licences issued for import and local manufacture. The authority notes that these lists may contain errors or omissions and should not be relied on as a definitive legal reference — which is precisely why procurement teams should request current documentation directly from the supplier rather than relying on a published list.

Establishment licence versus product registration

Two distinct things are often confused.

An establishment licence authorises a company to import or manufacture medical devices at all. A device registration or enlistment applies to a specific product. A supplier holding a valid establishment licence has not thereby registered every product in its catalogue.

When evaluating a supplier, ask for both: the establishment licence, and the registration or enlistment evidence for the specific devices being quoted.

Why classification determines the pathway

Devices are classified by risk into Classes A, B, C and D, with Class A the lowest risk and Class D the highest. Classification determines the evidence required and the regulatory route a device follows.

A Class A device — a simple non-invasive instrument, for example — carries a far lighter evidentiary burden than a Class D implantable or life-supporting device. Procurement timelines differ accordingly, and a tender that assumes identical lead times across classes will slip.

What procurement teams should request

For any imported device, a defensible file contains: the supplier's establishment licence; registration or enlistment evidence for the specific device; the manufacturer's authorisation letter naming the distributor; the certificate of origin and free-sale certificate where applicable; and the declared risk classification.

For tender submissions, this documentation is usually mandatory rather than optional. Assembling it after award is the most common cause of delay.

Where to verify

Always verify current status with DRAP directly, and request dated documentation from your supplier. Regulatory requirements and procedures change; any guide, including this one, should be treated as orientation rather than a substitute for the current rules.