Is It Illegal to Sell Medical Supplies?

The answer to the above question will depend on the supplies. If you intend to sell things like a stethoscope, then it is legal and not an issue. But if your supplies are leftover pain medication, then it is considered illegal.

If the Food and Drug Administration requires you to have a prescription to obtain medication or other medical devices, then it is also illegal to resell that item online.

That’s considered drug dealing, a crime that could result in lengthy jail time, depending on the jurisdiction and classification of the drug in question. Note that if you intend to sell or import medical supplies in America, you need to obtain FDA approval for the supplies.

Approval by the FDA Center for Devices and Radiological Health (CDRH) is required to export any kind of medical device to the United States. The procedure involves various steps: first of all, it is imperative to determine whether the product is considered a “medical device.” If not, authorization will have to be asked to other FDA departments.

The device is expected then to be classified according to CDRH rules. Depending on the characteristics of the product, it may be placed in regulatory classes I, II, or III. Classification is very crucial, as requirements and regulations vary accordingly.

For instance, while many class I products are eligible for exemptions; class III products require a more detailed set of documents. Preparation and presentation of the marketing application is the last and fundamental step to obtain FDA approval. It is critical to note that importers are expected to make sure the device meets all labeling requirements as well.

Also, the company will register at the FDA and declare the products it intends to sell on the American Market. Things like beds, walkers, and canes are easy to sell because they are often adjustable, and the chances of fitting the new buyer’s needs are high.

Other types of medical equipment, such as commode chairs or wheelchairs, are only useful for a specific type of diagnosis; therefore, the pool of buyers might be more limited.

How to Start Selling Medical Supplies

Doctors and other medical professionals indeed depend on high-quality equipment to treat patients. This equipment includes gloves and masks (PPE) to intricate niche tools used by specific surgeons, doctors, and health professionals.

However, with market size expected to reach 160 Billion USD by 2025, and a CRGA growth rate of 7.2 percent, it’s an opportunity to consider. Nonetheless, here are steps to consider when looking to sell medical supplies in the United States.

1. Choose A Medical Niche Or Underserved Market

Starting and managing a medical supply business is like starting and managing any other company in that you need to find what makes your brand unique. Once you understand that, you can find your target market and work to set yourself apart from competitors. Ask questions like these to better understand what you bring to the industry:

• Are you an expert in a medical niche and know what certain specialists need?
• Are you an ex-doctor or medical professional with real-life medical experience?
• Is there an underserved market that needs a reliable source of medical supplies?
• Do you have an idea for getting supplies to doctors faster or better, like a subscription service or convenient online portal?

2. Determine Your Business Type

In the United States, once you have a business idea; the next thing is to form your company. Decide whether you want to function as a Limited Liability Corporation (LLC), C-Corporation, or S-Corporation. Note that the type of business you choose will depend on your business structure and affect how you are taxed, what fees you need to pay, whether or not you need to raise capital, and more.

It is advisable you work with a local accountant to help you decide what is best for your business and refer to the BizFilings business type comparison tool to get a better understanding of your options.

Don’t forget that every state has its own guidelines and costs for forming a business, such as whether you need to produce annual reports or pay annual fees to stay operational. Understanding all of these details will help you choose the right business entity for your new medical supply venture.

3. Secure Your Operating Licenses

Coupled with registering your company, you will be expected to secure business licenses and permits necessary for a medical supply business.

Forming an LLC or C-Corp doesn’t necessarily mean you can legally operate, just that the state knows you exist—you must get your licenses or permits secured before beginning. Note that fees will vary from state to state and may be based on annual revenue.

4. Fund Your Business

Crucial to any good business is accurate bookkeeping and a strong financial footing. You are expected to have a clear understanding of how you plan to fund your medical supply company and how this funding will influence your budget now and in the future. A few funding options include:

• Bootstrapping: This means depending solely on your own money.
• Small business loan: To secure a loan, you will have to seek the expertise of a financial lender to get financing.
• Investors: With an investor, you will work with private entities to receive funds and then share part of your profits as your business grows.
• Crowd-funding: Use a site like Gofund to fund your business with donations from people around the world. This is a good option for companies with a socially driven mission.

Have it in mind that the viability of these medical supply financing options will vary depending on your business size and start-up costs and, each option also has its own benefits and drawbacks. For example, you don’t have to share your profits or make interest payments by bootstrapping, but that may not be an option if you don’t have access to start-up capital.

5. Identify Vendors And Distributors

Note that the foundation of your supply business will be working closely with medical distributors and vendors. These are large-scale manufacturers who produce millions of supplies each year who then sell to distributors like yourself so you can market and sell the wares on a smaller scale. Howbeit, when choosing your supplier(s) and vendor(s), consider a few key factors:

• Future innovation: Does your supplier have plans to grow and innovate in the coming years, ensuring that you stay relevant as a business as well?
• Communication: How well are they at communicating with you? Are their terms and business details clear?
• Expertise: How well do they know their market? How much can you benefit from their expertise?
• Quality: Are they as committed to quality as you are?
• Delivery systems: Will their delivery systems make it easier to run your business or are they complicated and difficult to manage?

All in all, ensure to work with a medical supply mentor or expert to better understand the qualities of successful medical supply partners and determine which potential vendors and distributors would be best for your specific needs.

6. Build Your Business And Market Your Brand

After you must have established what your business is and how it operates, the only thing left to do is execute your business and marketing plan. Within this period, you will open your warehouse, website, or both, ensuring that you have a place to house the medical supplies and/or manage orders.

Note that you also need to use this time to develop marketing materials and start reaching out to potential clients. Your industry may need different marketing methods, so be sure to do your market research first. This will help you dial in on who you want to target and how to best reach them.