Working with a Turkish Medical Device Manufacturer: A Practical Guide

Working with a Turkish medical device manufacturer such as DESU is straightforward when expectations are set early. Agree shipping terms using Incoterms, know which documents travel with each shipment and which quality documents can be requested, and set up communication routines that bridge the seven- or eight-hour time difference with the US East Coast.

Many distributors are used to buying from domestic or Western European manufacturers. Adding a partner in Türkiye raises practical questions about freight, paperwork, language and timing. This guide answers them from DESU’s side, for distributors considering lines such as DURASHEET, DECOLL or the EVD-010 Series.

Who is DESU, and how is it set up?

DESU was founded in 2007 as a research and development company at Hacettepe Teknokent in Ankara, Türkiye. It designs and manufactures neurosurgery and biomaterial devices in its own cleanrooms, with 5,000 m² of production. Its products carry the CE mark and are made under an ISO 13485 quality management system.

DESU exports to more than 50 countries and holds product registrations in 34. That export experience matters for a new distributor: shipping documents, labeling questions and partner communication are routine work for the team, not exceptions.

Because DESU both designs and manufactures its products, distributors can reach people who know the product in detail. Questions about materials, packaging or documentation do not have to pass through a chain of intermediaries.

The product range is also broad within one specialty. External drainage systems, catheter kits, shunts, collagen dural grafts and collagen bone grafts come from the same manufacturer and the same quality system. For a distributor, that means one set of shipping routines, one documentation process and one partner to build a neurosurgery business with.

How do shipments usually travel?

Sterile medical devices such as dural grafts, catheter kits and drainage systems are relatively light and compact for their value, so air freight is a common choice for international shipments. Sea freight may make sense for larger, less urgent consolidated orders. The right choice depends on volume, urgency and cost, and is agreed between the distributor and the manufacturer.

The division of responsibilities is set by the Incoterms rule written into the order or agreement. Incoterms 2020, published by the International Chamber of Commerce, are the common reference. The rules most often discussed are summarized below in simplified form.

Most distributors work with their own freight forwarder and customs broker, who can advise which rule suits their setup. What matters most is that the rule and the named place are written down clearly for every order, so there is no doubt about who arranges, pays and insures each stage.

Which documents travel with each shipment?

Each international shipment carries a set of commercial and transport documents. The exact set depends on the route, the Incoterm and the importer’s needs, but a distributor can usually expect:

• A commercial invoice listing products, quantities and values.
• A packing list showing how goods are packed, ideally with product codes, lot numbers and expiry dates.
• The transport document, such as an air waybill.
• A certificate of origin where the importer or customs broker requires one.
• Any additional documents agreed in advance for the distributor’s receiving and traceability process.

Agree before the first shipment exactly which documents the distributor’s broker and warehouse need, in which format and when. Sending a sample document set in advance avoids delays when the first real shipment lands.

Receiving checks deserve the same attention. On arrival, the distributor’s team should compare the packing list with the goods, record lot numbers and expiry dates, inspect outer cartons for damage and report any discrepancy to DESU promptly, with photographs. Problems found at receiving are easy to resolve; problems found weeks later in a hospital are not.

Which quality documents can a distributor request?

Beyond shipping paperwork, distributors and their hospital customers often need quality and product documentation. Typical requests include:

• The current ISO 13485 certificate covering the manufacturing site.
• CE certificates and declarations of conformity for the relevant products.
• Instructions for use and label samples.
• Product catalogues and specifications.
• Information on biological evaluation and, for collagen products, on animal-origin controls.

DESU provides documentation to its partners on request. Some technical documents are shared in summary form or under confidentiality terms; a DESU product specialist can explain what is available for each product and how to request it. Labels follow standardized conventions, such as the symbols in ISO 15223-1, which helps receiving staff find lot and expiry information.

How does communication work across time zones?

Türkiye uses UTC+3 all year. That puts Ankara seven hours ahead of US Eastern time in summer and eight hours ahead in winter, with larger gaps for Central, Mountain and Pacific time. The working days overlap in the US morning, especially on the East Coast.

In practice, a few routines keep communication smooth:

• A named contact at DESU and at the distributor, each with a deputy.
• Written communication in English by email, with clear subject lines for orders, quality questions and complaints.
• Questions sent at the end of the US day are answered at the start of the next Ankara working day.
• Regular scheduled calls in the overlap window for forecasts, account updates and open issues.
• Urgent matters, such as complaints, flagged clearly and sent immediately.

Plan around holidays at both ends. Türkiye observes national holidays and two religious holidays, Ramadan Feast and Feast of Sacrifice, whose dates move each year with the lunar calendar. US holidays affect customs brokers and domestic carriers. A shared calendar of these dates, reviewed at the start of each year, prevents orders from arriving during a closure.

How are commercial terms set?

Pricing, payment terms, order quantities, territory and service expectations are agreed individually in a distribution agreement. They depend on the market, the products, the expected volumes and the role the distributor will play, whether stocking, consignment, case coverage or all three.

A clear agreement also covers the topics that matter when something goes wrong: complaint handling, returns, recalls and field safety notices, and how documentation is updated. Settling these points before the first order makes the partnership easier to run.

It is worth discussing the first year in particular. New lines usually start with evaluations and a few early accounts, so order patterns are irregular. Agreeing how the first orders, evaluation stock and initial forecasts will be handled sets realistic expectations on both sides.

What makes the partnership work over time?

The most successful manufacturer–distributor relationships share a few habits. The distributor shares forecasts and account news honestly. The manufacturer answers questions quickly and explains decisions. Both sides pass on feedback from surgeons and nurses, and both treat complaints as information rather than as blame.

Distance makes these habits more important, not less. A distributor that hears from its manufacturer only when an invoice arrives will feel the distance. One that has a regular call, a known contact and quick answers will hardly notice it.

Talk to a DESU product specialist

If you are considering a partnership with DESU and want to understand shipping, documentation and communication in detail for your market, DESU’s product specialists are ready to talk. Write to sales@desu.tr, call +90 312 299 25 63, or use the contact page.