How to find a medical device distributor in a new country.

Step 1: confirm you can sell there

Check two things first: what your CE marking or FDA clearance is worth there, and who must hold the registration. Many regulators rely on it. Australia's TGA accepts EU notified body certificates and FDA decisions as comparable overseas evidence. Singapore's HSA runs abridged routes for devices a reference agency has approved. Saudi Arabia's SFDA runs a reliance route on approvals from the EEA, FDA, Health Canada, TGA, PMDA and the MHRA.

All three also need a local company to hold or file the registration. Often that is the distributor, and the choice outlives the contract. Read who holds the registration before your first call. Every country page shows the route and the holder rule, with its source, and the registration pages name the companies that hold registrations in each market.

General information, not legal advice. Local law varies; take local counsel.

Step 2: build the long list from the registries

Regulators license the companies that import, distribute or hold registrations, and most publish the list. Know what each one leaves out.

The Distributor Index puts these registries and others in one search, with 15,029 independent distributors, each linked to its source. Start from a country page or a segment page such as orthopaedics, and download the CSV. For Europe, read who imports devices into the EU first.

Step 3: narrow by fit

Cut the long list with five questions. The registry answers most of them.

• Segment. Does it already sell to your buyer? The device listings behind each company show it.
• Principals. Lines that sell to the same buyer are good. Your direct competitor is not.
• Competing lines. One is a conflict. Rule it out now, not after the NDA.
• Cities. Does it cover the hospitals you need, or only the capital?
• Size. With 150 principals you may get a shelf, not a sales team. With three, maybe no reach.

The portfolio fit guide goes deeper on reading a line card.

Step 4: check the shortlist

Keep ten to fifteen. For each, confirm the licence in the regulator's register, read the website, look for tender awards, and note the one question the call must answer. Score them on one sheet with the selection scorecard, then run the due diligence checklist on the finalists.

Step 5: first contact with a one-page brief

Distributors reply when they can see the business on one page. Put five things on it:

1. The device, the buyer and the clinical problem, in three lines.
2. Registration status: what you hold, and the likely route in their market.
3. What you provide: training, demo stock, clinical support, marketing.
4. A margin range, or the end price and how you set the transfer price.
5. What you expect: targets, reporting, and who holds the registration.

Send it to the commercial lead by name. Follow up once after a week. Silence is an answer.

Worked example

An illustration, not a client case. A 25-person European maker of a CE-marked trauma fixation system looks at Israel. The Israel page shows that registration rests on approval in a recognised country, the EU among them, and needs an Israeli holder. The Israel orthopaedics page lists 248 licensed firms with orthopaedic devices on record, 155 of them independent distributors (Bastion Hale Distributor Index, build of 25 October 2026). The maker strikes firms with a competing trauma line, checks licences and tender history on the rest, and briefs the twelve that remain.

Other routes, and when they fit

• National export agency: good if you qualify. One market per request; one published quote is about €3,563 and 8 to 12 weeks (AHK Southern Africa).
• Regulatory consultancy: when you also need the registration and a local representative.
• Trade show: when you are going anyway. Book meetings with your shortlist before you fly. See the trade show guide.
• Contact database: when you know the companies and need a person.

The options compared puts prices and coverage side by side, with sources.

Common mistakes

• Signing the first distributor who replies.
• Letting the distributor hold the registration because nobody asked.
• Treating EUDAMED as a distributor list.