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Romania restricts who may install and service a device. MediGear partners holding that cover bid for work others cannot touch.
Romania has been rebuilding hospital infrastructure with national recovery and EU structural funding, which has generated an unusually large pipeline of equipment tenders. Those projects carry audit obligations that shape how suppliers must document everything.
MediGear is a UK-registered medical equipment distributor and B2B marketplace working with verified manufacturers and healthcare buyers in more than 80 countries. Its partner program opens that catalogue to Romanian businesses selling into county emergency hospitals, university hospitals in Bucharest, Cluj and Iași, private hospital groups, laboratories and dental practices.
Three program tracks are open to Romanian businesses. Different business models, the same catalogue behind them — the right one depends on how much of the transaction you want to own.
Agents introduce qualified hospitals, clinics, distributors and procurement teams to MediGear. The role focuses on generating opportunities and connecting buyers with the team; MediGear handles quotations, supply, documentation and fulfilment. Earnings are commission-based on confirmed sales; no purchasing or inventory is required, and sales materials and product support are provided. It suits consultants and independent representatives who understand how a recovery-funded hospital project is specified, awarded and audited.
Distributors represent MediGear in an agreed country, region or territory and actively develop the local market — one county, a grouping such as Cluj and Bihor, or a single category nationally. Products are purchased at distributor level for onward supply, and territorial rights may be exclusive or non-exclusive. Market development, commercial support, and regulatory and import coordination are included.
Resellers purchase at wholesale and resell independently through an existing medical business, online store, sales network or customer base. Order quantities are flexible, and you sell on your own terms to your own customers. Resellers operate independently without territorial or official distribution rights, so there is no territorial commitment and no market development obligation.
The program is open to companies entered in the Romanian trade register with a genuine route to healthcare buyers. Applications commonly come from:
Equipment distributors and importers already supplying public and private hospitals
Independent sales agents with contacts in theatre, imaging, pathology or dental
Online medical supply retailers and e-commerce operators
Biomedical engineering firms adding equipment sales to service contracts
Practice fit-out, day surgery and healthcare project companies
Dental, laboratory and rehabilitation equipment resellers
Funding-project experience is the qualifier. A small Bucharest agency that has delivered against audit requirements beats a larger firm without that record.
Competitive margins. Partner-level commercial terms apply across the catalogue, with performance recognised for partners who hit agreed targets.
Full product catalogue. Certified equipment across diagnostics, surgical and therapeutic, lab and pathology, sterilisation, hospital furniture, dental, ENT and ophthalmic, rehabilitation, orthopaedic, cardiology, gastroenterology, neonatal, dermatology, veterinary and spare parts.
Sourcing and quotation support. Send an enquiry and the team sources the product, negotiates with the manufacturer and returns a documented quotation — including items outside the current catalogue.
Direct partnerships team. Order queries, supplier negotiations, logistics coordination, and after-sales issues go straight to the team by email, so you can focus on selling rather than chasing suppliers.
Marketing support. Co-branded brochures, digital assets, product imagery and joint campaigns you can put in front of Australian buyers.
Regulatory support. Country-specific import guidance, certification documentation and connections to local regulatory consultants for market entry questions.
Medical devices sold anywhere in the European Union fall under Regulation (EU) 2017/745, which fixes classification, conformity assessment and post-market duties before any supply arrangement begins. The national competent authority is the National Agency for Medicines and Medical Devices, covering market surveillance, vigilance and national registration; its guidance is published by ANMDMR.
Romania has its own national rules on top of these. Firms that handle devices must register. So must firms that install or service them. Labels and user guides are expected in Romanian. The wider structure is set out in the EU medical devices framework.
Entry formalities for non-union goods fall to the Romanian Customs Authority under Union Customs Code procedures. MediGear is not the economic operator of record for partner products and does not give regulatory advice.
Apply online. Complete the partner application form and tell us about your market, your experience and which track interests you.
Discovery call. The partnerships team reviews your application and arranges a call to discuss goals, coverage and fit.
Agreement and onboarding. Sign the partner agreement and complete onboarding, including commercial terms, product training and marketing assets.
Start earning. Begin selling, distributing, or referring while MediGear coordinates manufacturing, documentation, and freight.
Service rights are the first edge here. Romania sets rules on who may install and service a device. A partner with that cover can bid for work others cannot touch.
Second is programme scope. Recovery-funded projects re-equip whole departments, and a supplier covering several categories competes for far more of the value.
Audit readiness is the third. Funded purchases are checked afterwards, so documentation that survives review protects both the buyer and the award.
This page is published for general business and information purposes and is not an offer of partnership. MediGear reviews all applications, and approval is not guaranteed. Any partnership that proceeds is governed by the written terms agreed between MediGear and the partner. Product availability, category coverage, territory arrangements, commercial terms and any commission or margin structure vary by application and may change. The regulatory information here is general information about the Romanian framework and is not legal, regulatory or professional advice. Requirements under Regulation (EU) 2017/745, and the national registration, service authorisation and language provisions administered by the National Agency for Medicines and Medical Devices, depend on the device, its classification and the role each party takes. Partner businesses remain responsible for confirming what applies to their own products, and should obtain qualified regulatory, customs or legal advice where required.
Apply with your business details, the counties you cover you cover and the track that interests you. The MediGear partnerships team reviews every application and will come back to you to discuss it.
The program is open to companies entered in the Romanian trade register with a genuine route to healthcare buyers: equipment distributors and importers, independent sales agents, online medical supply retailers, biomedical engineering firms, practice fit-out companies, and dental, laboratory or rehabilitation resellers. Speciality experience carries more weight than company size.
Three. Sales agents introduce hospitals, clinics, distributors and procurement teams and earn commission on confirmed sales without holding stock. Authorised distributors represent MediGear in an agreed territory, purchase at distributor level and develop the local market. Resellers buy at wholesale and resell independently through a business they already run, without territorial rights or commitments.
No. Joining is free for Romanian businesses. There are no registration charges, subscriptions or upfront payments required to become an agent, distributor or reseller. Distributors and resellers purchase the products they sell, and partners cover their own trading costs, such as local delivery, storage, and any marketing they run beyond the assets MediGear provides.
Agents earn commission on confirmed sales rather than a retainer. The rate depends on the product category, the order value and the volume you bring, and is confirmed in writing before you begin introducing buyers. Because agents hold no stock and carry no inventory risk, earnings simply follow completed orders.
Exclusive territorial rights are available to qualified distributors who can demonstrate market reach, financial capability and alignment with MediGear standards, and are assessed case by case. Non-exclusive distribution is also offered and is more common for partners entering a new product category. A territory may be one county, a region, or national coverage of one product group.
Partners receive onboarding, product knowledge materials, regulatory guidance for their market, sales tools and co-branded marketing assets. The partnerships team handles order queries, supplier negotiations and logistics coordination, including certification and customs documentation for inbound consignments.
Romania has required economic operators handling medical devices, and those providing installation and maintenance services, to register or hold authorisation nationally, alongside the CE marking and conformity assessment required by Regulation (EU) 2017/745. MediGear is not the economic operator of record for partner products, so confirm your own duties with the agency.
Romanian-language labelling and instructions for use are expected for devices supplied to users, and tender documents make this a condition of award. The precise scope depends on the device, its class and its intended user, so confirm the requirement for each product before bidding.