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Exempt, notified or approved changes the entire plan. MediGear partners in the United States settle that question from manufacturer documentation.
The United States is the largest medical equipment market in the world, bought through hospital systems, group purchasing organisations and a vast independent physician and dental sector. Group purchasing contracts shape access to a very large share of hospital purchasing.
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 US businesses selling into hospital systems and academic medical centres, group purchasing organisations, ambulatory surgery centres, physician practices, clinical laboratories and dental offices.
Three program tracks are open to US 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 group purchasing organisation contract and a health system value analysis committee each work.
Distributors represent MediGear in an agreed country, region or territory and actively develop the local market — a single state, a region such as the Southeast or the Mountain West, or national coverage of one product group. 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 US companies holding an EIN and 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
Ambulatory surgery, dental and veterinary equipment resellers
Committee credibility is the qualifier. A small Chicago agency that has taken a product through a value analysis committee is worth more than a larger firm that has not.
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 are regulated by the Food and Drug Administration under a risk-based classification system, with Class I, II and III devices subject to different controls. Most Class II devices reach the market through premarket notification, and requirements are published by the FDA.
Establishments that manufacture, import or distribute devices are generally required to register with the agency and list their products, with initial importers carrying specific duties. Foreign manufacturers must designate a United States agent, and the process is set out in the device registration and listing guidance.
Imported consignments are cleared by US Customs and Border Protection, with the agency screening entries for regulatory status at the same time. MediGear is not the registrant for partner products, initial importer or United States agent, 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.
Clearance pathway clarity is the first advantage. Knowing whether a product is exempt, notified or requires approval changes the entire commercial plan, and manufacturer documentation is what settles that question.
Second is contract reach. Group purchasing organisations award category by category, and every additional category a supplier can bid is another committed volume they become eligible for.
Reference value is the third. A clearance obtained here is treated as strong supporting evidence by regulators in many other markets, which makes US entry strategically useful beyond its own revenue.
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 US framework and is not legal, regulatory or professional advice. Requirements administered by the Food and Drug Administration, including device classification, premarket notification or approval, establishment registration and listing, and the designation of a United States agent, depend on the device, its class and its intended use. 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 states 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 US companies holding an EIN and a genuine route to healthcare buyers: equipment distributors and importers, independent sales agents, online medical supply retailers, biomedical engineering firms, healthcare project companies, and ambulatory surgery, dental or veterinary 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 US 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 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 state, a group of states, or national coverage of a single 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.
It depends on the class. Many Class I devices are exempt from premarket review, most Class II devices reach the market through premarket notification, and Class III devices generally require premarket approval. Establishments must also register and list their products, and foreign manufacturers must designate a United States agent. MediGear is not the registrant for partner products, so confirm your own position with the agency.
No. A CE marking issued under the European regulation has no standing in the United States. The device must follow the applicable US pathway for its class, and the establishment must be registered with the product listed. Confirm the route for each device before quoting.