Medical Instrument Exporters in Pakistan

No. DRAP enlistment, registration and export permits govern Pakistan's own market and exports from it. They do not authorize sale anywhere else. A Pakistani manufacturer exporting to the EU must meet the EU MDR, including CE marking for the correct class (Class Ir for reusable surgical instruments, with notified body review of reuse aspects) and an EU authorized representative, because non-EU manufacturers cannot place devices on the EU market without one.

For the United States, the foreign establishment must register with FDA, list its devices, designate a US agent and meet the applicable classification and QMSR requirements. Use the Pakistan country page to find suppliers, then ask each one which destination-market documents it holds.

Pakistan

Start on the Sialkot city page and shortlist companies whose profiles mention the specialty you need, for example dental, ENT, ophthalmic or orthopedic instruments. Then compare like with like:

• ask each for the same pattern list and sizes, with the steel grade and finish;
• request samples of the same patterns and test them side by side;
• check that ISO 13485 scope and any CE or FDA evidence cover that specialty, not just general instruments;
• for specialties classified differently (some US dental, ophthalmic and orthopedic instruments sit outside 21 CFR 878.4800), confirm the regulatory route per product.

Instrument specialty pages such as Dental help you build the pattern list first.

Sialkot

The directory currently lists more than 650 companies in Sialkot. Many describe themselves as manufacturers, exporters or both, and these roles are self-stated. The Sialkot manufacturers filter narrows the list to companies stating a manufacturing role. To test the claim, ask for:

• an ISO 13485 certificate whose scope includes manufacture and names the Sialkot site address;
• the company's DRAP establishment license to manufacture, which is issued per premises;
• for EU sales, a Declaration of Conformity naming the company as legal manufacturer, and for US sales, its FDA registration as manufacturer;
• a factory visit or a third-party audit report.

A trading exporter can be a good partner, but it should name the actual maker of each item. See the Sialkot city page.

Sialkot manufacturers

Check rather than assume. Under DRAP's Medical Devices Rules, 2017, an establishment license to manufacture or import is issued for specific premises, with a separate license for each. A company with a head office or sales office in Lahore may manufacture in Sialkot or elsewhere, and its license, ISO 13485 certificate and FDA registration should name the actual production site.

The directory currently lists more than 10 companies in Lahore, compared with more than 650 in Sialkot. Ask Lahore-listed suppliers whether they manufacture, export products made by others, or import for the Pakistani market, and which DRAP license applies. See the Pakistan country page.

Lahore