How to export surgical instruments made in Pakistan to overseas markets

Pakistan, particularly Sialkot, is recognised globally as a manufacturer of high-quality surgical instruments. Sialkot alone produces 99% of the country’s production, making it the nerve centre of Pakistan's surgical industry and an important supplier in the global market. These instruments cater to a broad array of medical fields, from diagnostic tools, general surgical instruments, and tools for specialties like neurology, dermatology, and gynaecology to the intricacies of ophthalmology, urology, and cardiovascular surgeries. 

Orders and specifications typically come from major medical markets worldwide, especially the United States (US), Germany, the United Kingdom (UK), and China. The US takes the top spot, making up 27% of Pakistan's exports as of 2021, the Small & Medium Enterprises Development Authority reported. 

The surgical industry’s stellar reputation and robust export orientation have led to an impressive export value of US$420.9 million. The vast majority of this export value is tied to instruments for medical, surgical, or veterinary sciences, pegged at US$416.8 million.

Operating primarily on a business-to-business model, local manufacturers in Pakistan produce surgical instruments according to the importing country's specifications. The importing entities then brand these equipment and distribute them to their respective markets as suppliers, reinforcing Pakistan’s pivotal role in the global surgical supply chain. 

If you’re a surgical instrument manufacturer in Pakistan seeking to tap into global demand, rest assured that you’re on the right path. However, as with any export venture, getting the basics right is essential for a smooth international shipping experience. 

Below, we map out all you need to know about shipping surgical instruments from Pakistan to the rest of the world.

Requirements when shipping surgical instruments overseas

1. Documentation

Accurate and complete documentation is critical when exporting surgical instruments from Pakistan. Essential documents typically include:

• Air waybill, or the transport label affixed on the package: This includes the shipper’s and receiver’s address and contact information, the type of goods and the quantities of each in the shipment alongside their Harmonised System (HS) codes, the total number of items/packages in the shipment, and the total weight and dimension. This also serves as a packing list.
• Customs invoice: Whether commercial or proforma, the customs invoice expands on the air waybill and provides information, including a breakdown of the transaction costs, identification number of the shipper and receiver, currency code, incoterms and reason for export.
• Proof of origin statement: This is to certify that the surgical instruments were made in Pakistan. 
• Export permits/licences: Pakistani businesses must obtain an export permit from Pakistan’s Medical Device Board (MDB) before exporting surgical instruments.
• Certificates: A test report must be issued by the Sialkot Material Testing Laboratory before the surgical equipment can be allowed for export.

There is also import documentation to prepare to be allowed entry into the destination country. For example, shipments of surgical instruments entering the US must come with proof of approval or clearance from the Food and Drug Administration (FDA). This certifies that the product is safe and effective for its intended use. When importing into the European Union (EU), businesses must comply with the Medical Devices Directive 93/42/EEC and obtain a CE marking for all instruments of surgery. In addition, the Directive also establishes labelling requirements, which include, among others, the trade name and address of the manufacturer or authorised representative in the EU on the label, outer packaging and usage instructions.

2. Duties & taxes

Pakistan levies a standard sales tax of 17% on exports, and an extra 1% is added should the customer be a non-Sales Tax registered consumer. Duties and taxes will differ based on the destination country. Most surgical instruments fall under the HS code 9018, and countries will apply their duties and taxes accordingly. For example, in the US, the general duty for surgical instruments following the Harmonised Tariff System (HTS) codes of the HS code 9018 is 0%. 

Pakistan’s free trade agreements (FTAs) with countries also entail reduced tariffs for businesses. For instance, the tariffs on surgical instruments entering China are from 4-8%, instead of the standard 13%, according to the revised tariff schedule of the China-Pakistan FTA.