For manufacturers of medical devices and pharmaceuticals

The question we hear most:

“We have the approval. Why are we not selling?”

Market entry and sales execution

We set up your market and put local sales teams to work in Europe, the Middle East, South Africa and Latin America, so your approval turns into orders. We also help European manufacturers enter China and Korea.

The real problem

Approval opens the door. A local team turns it into sales.

You have invested in registration, CE marking and an authorised representative. That is an important achievement. But approval alone does not create orders. Hospitals and clinics expect a local contact, distributors need support and clear targets, and head office needs to see what happens in each market. Our work starts where the regulatory work ends.

We know how much time and money goes into registration. That investment should come back as orders, not as stock waiting in a warehouse.

We believe an approved product should be sold, not stored.

Registration is not a launch

The product is approved and a distributor is signed, but sales do not follow. No one in the market is responsible for the result.

Every region plays by its own rules

Europe, the Middle East, South Africa and Latin America differ in regulation, language, channels and how people buy.

Not visible to buyers

There is no local website, no material in the local language and no one at trade fairs or on clinic visits. Buyers choose brands they can see and meet.

Without Aurienta

  • Approvals, but no sales

  • One English brochure for every market

  • Distributors left alone after signing

  • Launch plans with no one to execute them

With Aurienta

  • Local sales teams from set-up to selling

  • Localised website, content and campaigns

  • Distributors coached, measured and supported

  • One plan per region, executed and reported

What we do for you

We do the work, not only the plan

We know how far away a market feels from head office. That is why you get one partner for set-up and execution across four regions.

One partner, four regions: Korean, Chinese and other Asian manufacturers work with Aurienta in Amsterdam for regulatory and importer set-up, local websites and content, local sales teams, marketing and trade fairs, and reporting in one dashboard, reaching the European Union, the Middle East, South Africa and Latin America.

Region strategy

Regions scored on evidence, with one plan and budget per region.

Local website and content

A local site per region and language, compliant product pages, sales material and lead capture into the CRM.

Local sales teams

Business developers and product specialists on the ground, who prospect, follow up and attend meetings for you, from set-up to selling.

Distributor and key-account search

A qualified shortlist, introductions and support in negotiating terms.

Regional marketing

Trade fairs, key opinion leader (KOL) programmes, digital campaigns, local-language content and pricing strategy for each market.

Regional challenges handled

Import logistics, invoicing in local currency and the questions buyers ask that head office can’t answer.

Reporting

A monthly dashboard and a quarterly business review across all regions.

Regulated roles, done properly

Aurienta can act as your EU importer. Roles that need a licence or specific qualification, such as the EU Authorised Representative, the person responsible for regulatory compliance (PRRC) and local registration holders, are provided by licensed partners under a transparent contract.

How it works

Three steps

Each step matches one of our packages.

01

Choose

Send your products, approvals and target regions. We score the regions and agree a plan and budget.

Package: Market Entry — Basic

02

Set up

Registration route, importer and partners, local website and content, and a local sales team in place.

Package: Market Entry — Professional

03

Sell and scale

Clinic visits, distributor coaching, campaigns and trade fairs, reported monthly and reviewed every quarter.

Package: Market Entry — Full Service

Regions

Where we take you

Europe is our home base. In all four regions you get a local sales team on the ground. We recommend starting with one or two regions and expanding from there.

Home base · AmsterdamEuropean Union
Local sales team · Gulf states (GCC) and wider regionMiddle East
Local sales team · Gateway to Southern AfricaSouth Africa
Local sales team · Brazil, Mexico and beyondLatin America

Packages

Three ways to start

Fixed fees, agreed per project before we start.

PackageWhat you getTypical length
Market Entry — BasicMarket assessment for two or three countries, regulatory pathway map with our partners, competitor and price benchmark, long-list of distributors and customers, go-to-market recommendation.6–8 weeks
Market Entry — ProfessionalBasic, plus shortlist, introductions and negotiations with distributors and key accounts, opinion-leader identification, pricing strategy and monthly pipeline reports.6 months, renewable
Market Entry — Full ServiceProfessional, plus Aurienta as EU importer for medical devices that pass our written acceptance check (certificate scope, declaration of conformity, labelling and recall procedure), order-to-cash through a partner warehouse and channel management.12 months, renewable

Fit

Is this right for you?

A good fit if

  • You manufacture medical devices, aesthetic products or cosmetics in Korea, China or elsewhere in Asia, and want to sell in Europe, the Middle East, South Africa or Latin America

  • You are a European manufacturer that wants to sell in China

  • You need people who execute locally, not only a registration

Not a fit if

  • You only need a regulatory dossier written. For that you need a regulatory consultancy.

  • You are looking for grey-market channels or shortcuts around registration

The other direction

European companies entering Asia

Our China Desk in Shanghai helps European manufacturers of materials, medical devices, aesthetic products and cosmetics enter China. We help you understand the market, check proposed distributors and partners, and build a sales channel. We arrange the licensed local partner needed for NMPA registration. Aurienta never acts as the legal agent itself.

The Shanghai skyline on the Huangpu River at dusk

Questions

Good to know

Which regions do you cover?

The European Union, the Middle East, South Africa and Latin America, and China for European manufacturers. We recommend starting with one or two regions and expanding from there.

Do you replace our distributors?

No. Our local teams support, coach and measure your distributors, and cover the key accounts they cannot reach alone.

Who holds the registration?

We agree this per region. Our advice is to keep the registration with a partner you can trust or replace, so a change of distributor never costs you market access.

Do you build the website too?

Yes. A local website per region and language is part of every launch, connected to the CRM so every lead is followed up.

This page is general information, not legal or regulatory advice.

What is at stake

Two ways this can go

If nothing changes

  • Registration costs turn into a sunk cost

  • Competitors take the shelf space while distributors make promises

With Aurienta

  • The goal for year one: a local team, a local website and active distributors

  • A monthly view of every order in every region

From approval to orders

Set-up and execution in one partnership, reported every month. Bring your product and target market to CPHI Milan, or write to us. We speak English, Chinese and Korean.