How to Become a Medical Supplies Distributor
In 2021, the UK medical equipment market share had an estimated value of £6.35 billion. The UK has Europe's third largest medical equipment market after Germany and France. Distribution of medical supplies can be a lucrative business, especially when you consider perks like dropshipping and white-label products. Where fewer resources need to be invested in building a brand reputation and making a profit in an industry that will never be out of demand, distribution is an enticing option for entrepreneurs everywhere.
But becoming a distributor isn’t without its hurdles. Different regulations, licenses, taxation, and shipping considerations demand you know exactly what measures you must meet in the business. This is especially significant if you’re considering specialising in healthcare and medical supplies, which concern the health and safety of consumers.
In this article, we’ll guide you through how to become a medical distributor in the UK and the considerations that ensure you stay on the right side of the law.
In 2021, the UK medical equipment market share had an estimated value of £6.35 billion. The UK has Europe's third largest medical equipment market after Germany and France. Distribution of medical supplies can be a lucrative business, especially when you consider perks like dropshipping and white-label products. Where fewer resources need to be invested in building a brand reputation and making a profit in an industry that will never be out of demand, distribution is an enticing option for entrepreneurs everywhere.
But becoming a distributor isn’t without its hurdles. Different regulations, licenses, taxation, and shipping considerations demand you know exactly what measures you must meet in the business. This is especially significant if you’re considering specialising in healthcare and medical supplies, which concern the health and safety of consumers.
In this article, we’ll guide you through how to become a medical distributor in the UK and the considerations that ensure you stay on the right side of the law.
How Do Medical Product Distributors Work?
A distributor is an intermediary between manufacturers and the businesses and consumers who use the products. This critical link in the supply chain means that consumers can easily access the items they need, and manufacturers make revenue from their products and continue to provide for the demand.
How Do Medical Product Distributors Work?
A distributor is an intermediary between manufacturers and the businesses and consumers who use the products. This critical link in the supply chain means that consumers can easily access the items they need, and manufacturers make revenue from their products and continue to provide for the demand.
The process a distributor carries out generally follows this pattern.
- Several businesses require certain products. For example, disposable vinyl gloves.
- The distributor notices the demand for vinyl gloves and seizes this opportunity, searching for manufacturers that make vinyl gloves.
- The distributor identifies a manufacturer and carries out various checks. For example, are the vinyl gloves made to EN standards, do they bear the CE mark, are they made to British Standards, and so on? This qualifies the manufacturer as a trustworthy source.
- The distributor partners with the manufacturer, and both parties enter an agreement whereby the manufacturer will supply X number of units to the distributor.
- On completion of an order of products, the distributor may hold the units in a warehouse and ship them or arrange dropshipping directly from the manufacturer.
The process a distributor carries out generally follows this pattern.
- Several businesses require certain products. For example, disposable vinyl gloves.
- The distributor notices the demand for vinyl gloves and seizes this opportunity, searching for manufacturers that make vinyl gloves.
- The distributor identifies a manufacturer and carries out various checks. For example, are the vinyl gloves made to EN standards, do they bear the CE mark, are they made to British Standards, and so on? This qualifies the manufacturer as a trustworthy source.
- The distributor partners with the manufacturer, and both parties enter an agreement whereby the manufacturer will supply X number of units to the distributor.
- On completion of an order of products, the distributor may hold the units in a warehouse and ship them or arrange dropshipping directly from the manufacturer.
Distributors are responsible for marketing the products their manufacturing partners make to relevant leads and often are responsible for transportation to customers.
Akin to a symbiotic relationship: the manufacturer makes revenue without having to market to consumers, and the distributor handles a portion of storage and transportation. The Distributor doesn’t need to worry about the costs associated with creating the products from which it profits.
Distributors are responsible for marketing the products their manufacturing partners make to relevant leads and often are responsible for transportation to customers.
Akin to a symbiotic relationship: the manufacturer makes revenue without having to market to consumers, and the distributor handles a portion of storage and transportation. The Distributor doesn’t need to worry about the costs associated with creating the products from which it profits.
How to Become a Medical Distributor
Deciding to niche in medical supplies means more security as there will always be a demand for medical supplies. But with higher reward comes higher expectations. You and your manufacturers must meet stringent regulations to ensure the products that go to market are safe.
How to Become a Medical Distributor
Deciding to niche in medical supplies means more security as there will always be a demand for medical supplies. But with higher reward comes higher expectations. You and your manufacturers must meet stringent regulations to ensure the products that go to market are safe.
Taking Preliminary Steps
As with setting up any business, your first steps involve creating a business plan and registering your business with Companies House. Creating a business plan allows you to see the scope of your work and accurately predict financial forecasts, which will assist you in securing bank loans if you plan to.
Your business should also start with in-depth market research. Identifying a niche or underserved market will make acquiring clients easier, giving your business a competitive edge rather than entering an overfull pool of other distributors. It’s better to select a specific area of medical supplies rather than ‘medical supplies’ in general, at least initially.
You could consider targeting a specific demographic, such as midwives, or select a type of product, such as defibrillators.
Taking Preliminary Steps
As with setting up any business, your first steps involve creating a business plan and registering your business with Companies House. Creating a business plan allows you to see the scope of your work and accurately predict financial forecasts, which will assist you in securing bank loans if you plan to.
Your business should also start with in-depth market research. Identifying a niche or underserved market will make acquiring clients easier, giving your business a competitive edge rather than entering an overfull pool of other distributors. It’s better to select a specific area of medical supplies rather than ‘medical supplies’ in general, at least initially.
You could consider targeting a specific demographic, such as midwives, or select a type of product, such as defibrillators.
Understand Medical Distributor Regulatory Requirements
When considering how to become a medical device, equipment, and supply distributor, you need to do more work than other distributors. Becoming a distributor in the medical industry is more sensitive than others because the products you handle directly impact people’s health and safety. Medical distributors must meet certain regulations and frameworks that regulate the supply of medical devices to UK consumers. Failure to meet these requirements could negatively impact your business.
The Medicines and Healthcare Products Regulatory Agency (MHRA) is the authority on the UK medical devices market. Devices must be registered with the MHRA to be sold in the UK.
UK Regulations and Laws that Medical Distributors Must Abide By
There are certain regulations and frameworks that medical distributors must meet to operate in the UK.
| Requirement | Details |
|---|---|
| Medical Devices Regulations 2002 | Legislation that sets out the requirement of safety and performance medical devices must meet to be used by UK consumers. |
| Medicines and Healthcare Products Regulatory Agency (MHRA) | The regulatory agency that demands medicine and medical devices meet legal safety, compliance, and performance standards. |
| ISO 13485 | A quality management system that requires organisations to demonstrate their medical devices meet certain standards to be sold to consumers. |
| General Data Protection Regulation (GDPR) | A regulation that requires businesses to handle personal and sensitive data in certain ways to protect consumers. |
| The Health and Safety Executive Legislation | Relevant health and safety requirements that all UK businesses must meet. These include handling, storing, and transporting medical devices. |
| The Environment Act 2021 | Legislation that UK businesses must comply with to ensure waste is disposed of properly and recycled where possible. For example, clinical waste and cytotoxic must be disposed of in specific ways. |
| Certificate to Export Medical Devices | You may need a certificate of free sale to export medical devices outside of the UK. |
| General Product Safety Regulations 2005 | Legislation that applies to consumer products broadly in the UK and expectations of safety and quality. |
| UK Bribery Act 2010 | Legislation that requires businesses to comply with anti-bribery and corruption laws and create policies to prevent unethical practices. |
| Insurance | UK businesses are responsible for understanding which types of liability insurance apply to them and implementing them, such as product liability insurance. |
| VAT and Tax Regulations | UK businesses are responsible for knowing and implementing whichever VAT registration and tax laws apply to them. |
Best Practices Distributors Should Follow
The following aren’t always required by law. But recommended as best practices to build a trusted brand reputation and provide the highest quality service available to your customers.
| Considerations | Details |
|---|---|
| Ethical Guidelines | Adhering to ethical business practices and being transparent in your work increases your trustworthiness and image. |
| Good Distribution Practice (GDP) | Adhering to GDP demonstrates that you are committed to certain standards of storage, transportation, and handling of products. |
| BSI UK (0086) | This is the approved UK body for assessing medical devices and IVDs. Meeting the requirements of any relevant notified and approved UK bodies helps you conform to expectations. |
| Industry Best Practices | Consult the WHO Good Storage and Distribution Practices for Medical Products and do your research to ensure you follow all relevant industry best practices. |
Joining trade associations and chambers of commerce in your industry or niche market can provide insights into best practices, open you up to support and networking opportunities, and send trust signals to your customers. For example, Steroplast is a Greater Manchester Chamber of Commerce member.
Understand Medical Distributor Regulatory Requirements
When considering how to become a medical device, equipment, and supply distributor, you need to do more work than other distributors. Becoming a distributor in the medical industry is more sensitive than others because the products you handle directly impact people’s health and safety. Medical distributors must meet certain regulations and frameworks that regulate the supply of medical devices to UK consumers. Failure to meet these requirements could negatively impact your business.
The Medicines and Healthcare Products Regulatory Agency (MHRA) is the authority on the UK medical devices market. Devices must be registered with the MHRA to be sold in the UK.
UK Regulations and Laws that Medical Distributors Must Abide By
There are certain regulations and frameworks that medical distributors must meet to operate in the UK.
| Requirement | Details |
|---|---|
| Medical Devices Regulations 2002 | Legislation that sets out the requirement of safety and performance medical devices must meet to be used by UK consumers. |
| Medicines and Healthcare Products Regulatory Agency (MHRA) | The regulatory agency that demands medicine and medical devices meet legal safety, compliance, and performance standards. |
| ISO 13485 | A quality management system that requires organisations to demonstrate their medical devices meet certain standards to be sold to consumers. |
| General Data Protection Regulation (GDPR) | A regulation that requires businesses to handle personal and sensitive data in certain ways to protect consumers. |
| The Health and Safety Executive Legislation | Relevant health and safety requirements that all UK businesses must meet. These include handling, storing, and transporting medical devices. |
| The Environment Act 2021 | Legislation that UK businesses must comply with to ensure waste is disposed of properly and recycled where possible. For example, clinical waste and cytotoxic must be disposed of in specific ways. |
| Certificate to Export Medical Devices | You may need a certificate of free sale to export medical devices outside of the UK. |
| General Product Safety Regulations 2005 | Legislation that applies to consumer products broadly in the UK and expectations of safety and quality. |
| UK Bribery Act 2010 | Legislation that requires businesses to comply with anti-bribery and corruption laws and create policies to prevent unethical practices. |
| Insurance | UK businesses are responsible for understanding which types of liability insurance apply to them and implementing them, such as product liability insurance. |
| VAT and Tax Regulations | UK businesses are responsible for knowing and implementing whichever VAT registration and tax laws apply to them. |
Best Practices Distributors Should Follow
The following aren’t always required by law. But recommended as best practices to build a trusted brand reputation and provide the highest quality service available to your customers.
| Considerations | Details |
|---|---|
| Ethical Guidelines | Adhering to ethical business practices and being transparent in your work increases your trustworthiness and image. |
| Good Distribution Practice (GDP) | Adhering to GDP demonstrates that you are committed to certain standards of storage, transportation, and handling of products. |
| BSI UK (0086) | This is the approved UK body for assessing medical devices and IVDs. Meeting the requirements of any relevant notified and approved UK bodies helps you conform to expectations. |
| Industry Best Practices | Consult the WHO Good Storage and Distribution Practices for Medical Products and do your research to ensure you follow all relevant industry best practices. |
Joining trade associations and chambers of commerce in your industry or niche market can provide insights into best practices, open you up to support and networking opportunities, and send trust signals to your customers. For example, Steroplast is a Greater Manchester Chamber of Commerce member.
Getting Your Wholesaler of Medicines Licence
It’s important to know whether you need to secure a license or permit to start distributing medical devices. In the UK, there’s no specific licensing required to sell medical devices. However, you must register with MHRA and comply with all the relevant regulations mentioned above that apply to you.
Getting Your Wholesaler of Medicines Licence
It’s important to know whether you need to secure a license or permit to start distributing medical devices. In the UK, there’s no specific licensing required to sell medical devices. However, you must register with MHRA and comply with all the relevant regulations mentioned above that apply to you.
Securing Funding
Unless you have a budget ready to start business operations, securing funding is essential. Your business plan and financial forecast will help you demonstrate when you expect to break even and how long your debtors can expect to wait before seeing their loans paid off.
The first place anyone might think to go for a loan is the bank, but there are other options. Consider:
- Partnerships: with manufacturers, healthcare providers, charities, and other industry stakeholders could lead to shared benefits.
- Angel investors: may be interested in supporting small or new businesses that want to service healthcare.
- Government grants: might be available in your niche. Search for grants that apply to you.
- Venture capital and private equity investors: are good options if you’re looking for a more significant investment and often invest in promising industries such as healthcare.
Securing Funding
Unless you have a budget ready to start business operations, securing funding is essential. Your business plan and financial forecast will help you demonstrate when you expect to break even and how long your debtors can expect to wait before seeing their loans paid off.
The first place anyone might think to go for a loan is the bank, but there are other options. Consider:
- Partnerships: with manufacturers, healthcare providers, charities, and other industry stakeholders could lead to shared benefits.
- Angel investors: may be interested in supporting small or new businesses that want to service healthcare.
- Government grants: might be available in your niche. Search for grants that apply to you.
- Venture capital and private equity investors: are good options if you’re looking for a more significant investment and often invest in promising industries such as healthcare.
Choosing Suppliers and Making Partnerships
Selecting good suppliers and manufacturers is very important because this is where your quality assurance starts. As a distributor, you have certain duties to your customers to provide products that meet safety and quality standards. You’ll want to ensure your suppliers meet these expectations.
It’s also a good idea to consider the supplier’s current state and position in the market. Is it set to innovate and grow? Is it well-established and trusted? Does it have certain commitments to quality and ethical practices?
Building good, strong relationships with suppliers is the cornerstone of your business as a distributor, so your due diligence at this step is crucial. Here are some starting points.
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Choosing Suppliers and Making Partnerships
Selecting good suppliers and manufacturers is very important because this is where your quality assurance starts. As a distributor, you have certain duties to your customers to provide products that meet safety and quality standards. You’ll want to ensure your suppliers meet these expectations.
It’s also a good idea to consider the supplier’s current state and position in the market. Is it set to innovate and grow? Is it well-established and trusted? Does it have certain commitments to quality and ethical practices?
Building good, strong relationships with suppliers is the cornerstone of your business as a distributor, so your due diligence at this step is crucial. Here are some starting points.
Click to expand:
Establish a Supply Chain
Once you’ve partnered with suppliers, you must establish supply chain logistics. This includes considerations like storage (depending on the products you distribute, you may need to think about temperature control, air quality, and security) and transportation (where and how should your goods be transported?). Transportation is less of a concern if your supplier offers dropshipping like Steroplast.
Don’t forget to adhere to any ethical, sustainability, and governance (ESG) policies you’ve committed to at every stage of your supply chain.
Establish a Supply Chain
Once you’ve partnered with suppliers, you must establish supply chain logistics. This includes considerations like storage (depending on the products you distribute, you may need to think about temperature control, air quality, and security) and transportation (where and how should your goods be transported?). Transportation is less of a concern if your supplier offers dropshipping like Steroplast.
Don’t forget to adhere to any ethical, sustainability, and governance (ESG) policies you’ve committed to at every stage of your supply chain.
Develop Marketing and Sales Strategies
Distributors are responsible for marketing the products they sell from their suppliers. Consider your market to identify the most attractive benefits to your customers. In the medical device market, these could be:
- Quality and safety assurance
- Product reviews and testimonials
- Fast delivery and cheap shipping
- Incentivised discounts and volume discounts
- Professional endorsement from household name brands
Develop Marketing and Sales Strategies
Distributors are responsible for marketing the products they sell from their suppliers. Consider your market to identify the most attractive benefits to your customers. In the medical device market, these could be:
- Quality and safety assurance
- Product reviews and testimonials
- Fast delivery and cheap shipping
- Incentivised discounts and volume discounts
- Professional endorsement from household name brands
How to Become a Pharmaceutical Distributor
Becoming a pharmaceutical distributor is slightly different from being a medical device distributor, even though these are in the same industry. Read on to see what additional considerations you must make if you plan to offer pharmaceuticals.
What is a pharmaceutical distributor?
Pharmaceutical distributors operate like medical device distributors, but they provide prescription-only medicine and pharmacy medicines to businesses and organisations. Clients of pharmaceutical distributors include hospitals, GP clinics, dentists, veterinary clinics, military and emergency organisations, pharmacies, and other licensed companies that use restricted medications, like dermatologists and aesthetics clinics.
In the table below, you can see a comparison between medical distributors and pharmaceutical distributors.
| Medical Distributor | Pharmaceutical Distributor |
|---|---|
| Concerned with devices and equipment used in medical and healthcare settings, such as surgical instruments and diagnostic equipment. | Concerned with prescription-only medicines, pharmacy medicines, and general sales list items. |
| Generally governed by UK Medical Devices Regulation (UK MDR) and the MHRA. | Generally governed by the Human Medicines Regulations, Good Distribution Practice (GDP) guidelines, and controlled drugs legislation. |
| Registration with MHRA and compliance with relevant regulations is required. | Wholesale Distribution Authorisation (WDA) from the MHRA is required, along with storage, handling, and shipping requirements met. |
How to Become a Pharmaceutical Distributor
Becoming a pharmaceutical distributor is slightly different from being a medical device distributor, even though these are in the same industry. Read on to see what additional considerations you must make if you plan to offer pharmaceuticals.
What is a pharmaceutical distributor?
Pharmaceutical distributors operate like medical device distributors, but they provide prescription-only medicine and pharmacy medicines to businesses and organisations. Clients of pharmaceutical distributors include hospitals, GP clinics, dentists, veterinary clinics, military and emergency organisations, pharmacies, and other licensed companies that use restricted medications, like dermatologists and aesthetics clinics.
In the table below, you can see a comparison between medical distributors and pharmaceutical distributors.
| Medical Distributor | Pharmaceutical Distributor |
|---|---|
| Concerned with devices and equipment used in medical and healthcare settings, such as surgical instruments and diagnostic equipment. | Concerned with prescription-only medicines, pharmacy medicines, and general sales list items. |
| Generally governed by UK Medical Devices Regulation (UK MDR) and the MHRA. | Generally governed by the Human Medicines Regulations, Good Distribution Practice (GDP) guidelines, and controlled drugs legislation. |
| Registration with MHRA and compliance with relevant regulations is required. | Wholesale Distribution Authorisation (WDA) from the MHRA is required, along with storage, handling, and shipping requirements met. |
How to Get a Wholesale Pharmaceutical Licence
Unlike medical distributors, UK authorities are more strict with pharmaceutical distributors. You are required to apply for and attain a Wholesale Distribution Authorisation (WDA) from the MHRA. To qualify for this, you must demonstrate to the MHRA that your business complies with EU good manufacturing practice (GMP), and your site must pass regular GMP inspections.
It’s highly likely if you plan to supply restricted medications that, you will need a Controlled Drugs Licence. This licence holds you accountable for strict handling and reporting duties and ensures you follow safe and responsible practices.
How to Get a Wholesale Pharmaceutical Licence
Unlike medical distributors, UK authorities are more strict with pharmaceutical distributors. You are required to apply for and attain a Wholesale Distribution Authorisation (WDA) from the MHRA. To qualify for this, you must demonstrate to the MHRA that your business complies with EU good manufacturing practice (GMP), and your site must pass regular GMP inspections.
It’s highly likely if you plan to supply restricted medications that, you will need a Controlled Drugs Licence. This licence holds you accountable for strict handling and reporting duties and ensures you follow safe and responsible practices.
Rules and Guidance for Pharmaceutical Distributors
In addition to a wholesale pharmaceutical licence, distributors have further expectations to adhere to.
- Validating suppliers: under the Good Distribution Practice (GDP) guidelines, pharmaceutical distributors are responsible for ensuring their suppliers are licensed, meet the quality standards they uphold, and comply with Good Manufacturing Practice (GMP).
- Pharmacovigilance: it’s possible that, as a distributor, you have the responsibility to report adverse effects, accidents, and safety issues to relevant notified bodies, usually RIDDOR.
- Appointing of qualified, responsible persons: distributors may be required to appoint a qualified person with the experience and licencing to ensure GDP is maintained.
Becoming a medical or pharmaceutical distributor can be a lucrative business choice, but it’s not without essential compliance to navigate. If you’re considering taking up this responsibility and becoming a distributor, talk to Steroplast. We help start-up and small distributors grow their brands with the help of our label and industry expertise.
Rules and Guidance for Pharmaceutical Distributors
In addition to a wholesale pharmaceutical licence, distributors have further expectations to adhere to.
- Validating suppliers: under the Good Distribution Practice (GDP) guidelines, pharmaceutical distributors are responsible for ensuring their suppliers are licensed, meet the quality standards they uphold, and comply with Good Manufacturing Practice (GMP).
- Pharmacovigilance: it’s possible that, as a distributor, you have the responsibility to report adverse effects, accidents, and safety issues to relevant notified bodies, usually RIDDOR.
- Appointing of qualified, responsible persons: distributors may be required to appoint a qualified person with the experience and licencing to ensure GDP is maintained.
Becoming a medical or pharmaceutical distributor can be a lucrative business choice, but it’s not without essential compliance to navigate. If you’re considering taking up this responsibility and becoming a distributor, talk to Steroplast. We help start-up and small distributors grow their brands with the help of our label and industry expertise.
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