Written and maintained by CASRAI Editorial Board
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This page describes products and general use; it is not medical advice.
Pakistan’s surgical instrument industry is concentrated in Sialkot, in Punjab, and works mostly as a build-to-specification supplier for foreign buyers. This guide is for buyers, clinic and supply staff, and students who need to understand how that industry is structured and which regulatory documents to ask a Pakistan-based instrument maker for.
What Pakistan’s surgical instrument industry is
Pakistan exports hand-held surgical instruments, mainly from one cluster of manufacturers. A study by the Pakistan Business Council and the Engineering Development Board, Enhancing the Competitiveness of Pakistan’s Surgical Instruments Industry (checked 2026-11-01), puts Pakistan’s share of world trade in HS code 901890 at about 0.7% over the decade and 0.6% in 2020. Exports in 2020 were US$361.3 million, against US$405.5 million in 2019, with a compound annual growth rate of 2.6% from 2016 to 2020.
Who uses these instruments: hospitals, clinics and surgical supply distributors abroad, which buy either finished products or instruments made to their own designs.
| Industry fact | What the PBC/EDB study reports |
|---|---|
| Location | Concentrated in Sialkot, Punjab |
| Structure | Highly fragmented: many small and medium enterprises and a few large units |
| Business model | Mostly OEM supplier, building to buyer specifications |
| Device classes made | Mainly Class I and some Class IIb instruments; competitive at the low-tech end |
| Main buyers | Buyers in Germany, the UK and the USA; these are the top three destinations |
| Export concentration | Nearly 80% of exports go to 15 countries |
Sialkot: how the cluster works
Sialkot surgical instruments are usually produced by a manufacturer working from the buyer’s specification, not from the maker’s own catalogue brand. The study describes the sector as mostly OEM supply. That arrangement is common in medical products generally; our comparison of private label, white label and OEM in medical products explains the terms.
The study also reports an absence of “Made in Pakistan” stamping on export products: exporters are neither branding nor stamping instruments with the label when exporting to Europe, and sometimes put it on the carton but not on the instruments themselves. For a buyer, it is sensible to ask for origin documentation rather than rely on a marking.
Classes and instrument types made
The study reports that Pakistani makers mainly produce Class I and some Class IIb instruments. Which class a particular instrument falls into depends on the regulator and the rules of the market where it is sold, so confirm the class under the rules of your own country. For material grades used in stainless steel instruments see ASTM F899; for one common instrument family, see surgical blade types, and for a specific pair of hand instruments, Crile vs Kelly forceps.
Regulatory documents to ask for
The checklist below ties each document to a source. It lists what to request, not a ruling that any supplier is or is not compliant.
| Document or record | Why it matters | Source |
|---|---|---|
| FDA establishment registration and device listing | Under 21 CFR 807.20, owners and operators of establishments that manufacture, prepare, assemble or process devices for human use must register and list devices in commercial distribution. The rule also covers specification developers, sterilizers, repackagers and relabelers, and initial importers. | 21 CFR 807.20, Cornell LII, checked 2026-11-01 |
| Importer listing details | An initial importer may meet its listing obligation by submitting the manufacturer’s name and address, so the manufacturer’s identity should be on record. | 21 CFR 807.20, checked 2026-11-01 |
| Country-of-origin documentation | The study reports “Made in Pakistan” stamping is often absent from the instruments (sometimes only on the carton), so ask the supplier to document origin. | PBC/EDB study, checked 2026-11-01 |
| Certificate of conformity | Documents conformity to the applicable requirements; see our certificate of conformity guide. | CASRAI guide |
| Labeling | See FDA labeling requirements for medical devices for US-market labeling. | CASRAI guide |
The rule itself states that registration or listing does not constitute an admission or agreement or determination that a product is a device.
Pakistan’s domestic rules and the export exemption
As reported by Customs Today on 2018-12-13, the Drug Regulatory Authority of Pakistan (DRAP) issued a notification dated 2018-12-06 exempting surgical instruments “for the purpose of export” from the Medical Devices Rules 2017, and withdrew an earlier notification, SRO 32(I)/2018 of 2018-01-16. The exemption, as reported, applies to export only. It is a point in time and a news report, so ask the supplier which rules govern the specific product you are buying.
The PBC/EDB study adds that the EU Medical Device Regulation became mandatory from 2024 and was expected to hinder EU exports at first. It suggests the Global Medical Device Nomenclature (GMDN) as one option for identifying instruments, and lists SIMAP-approved certification requirements for exporters among self-regulation options. SIMAP is the Surgical Instruments Manufacturers Association of Pakistan.
How to compare manufacturers
Questions worth putting to a maker:
- Ask whether the maker, or the party that specifies the design, appears in an FDA registration and listing record (21 CFR 807.20).
- Ask for origin documentation, because the study reports instruments are often not stamped with the country of origin.
- Ask what regulatory documents cover the target market, including a certificate of conformity.
- Confirm whether the instruments are made to your specification or the maker’s own design, since the sector is mostly OEM.
For reusable versus single-use products, see autoclavable vs single-use surgical instruments.
Common mistakes
- Treating FDA registration or listing as an approval of the product; the rule says it is not a determination that a product is a device.
- Assuming the instrument shows where it was made; the study reports “Made in Pakistan” stamping is often absent from instruments.
- Treating the 2018 export exemption as proof of a supplier’s status in any market.
FAQ
What are Sialkot surgical instruments?
They are instruments made by manufacturers in Sialkot, Punjab, where Pakistan’s surgical instrument industry is concentrated, mostly as OEM suppliers building to buyer specifications (PBC/EDB study).
Who are the Pakistan surgical instruments manufacturers?
The study describes a highly fragmented sector of many small and medium enterprises and a few large units. This page does not name or rank companies.
Where do Pakistan’s surgical instruments go?
The top three destinations are the USA, Germany and the UK, and nearly 80% of exports go to 15 countries (PBC/EDB study).
Sources
- Pakistan Business Council and Engineering Development Board, Enhancing the Competitiveness of Pakistan’s Surgical Instruments Industry, https://www.pbc.org.pk/?p=5301 (checked 2026-11-01).
- Customs Today, “DRAP exempts Sialkot’s surgical industry instruments from MDR 2017”, 2018-12-13, https://customstoday.media/drap-exempts-sialkots-surgical-industry-instruments-from-mdr-2017/ (checked 2026-11-01).
- 21 CFR 807.20, Cornell Legal Information Institute, https://www.law.cornell.edu/cfr/text/21/807.20 (checked 2026-11-01).
