Licenses and Permits
Depending upon the nature of your business and location, you may need various federal and state licenses and permits for your small business. Become aware of the fees and waiting periods involved. Keep track of expiration/renewal dates. Examples:
- Sellers permit – If you sell tangible items to the public, you may need this permit from your state.
- If a federal agency regulates your business activities you need a permit or license. For example, in agriculture, if you import or transport animals, animal products, biologics, biotechnology including genetically engineered organisms, or plants across states lines, check with the U.S. Deparment of Agriculture.
Other Requirements to Launch a Business
Open account(s) when you are ready to spend or accept money as a business. First, get your federal employer identification number (EIN). Other documents you will need include your business formation documents, ownership agreements, and business license. Include a merchant services account if you will accept credit card transactions.
Business structure (such as being a limited liability company (LLC) or a corporation provides limited protection for your personal property from lawsuits. To protect personal assets and to fully protect your business, you will need business insurance. View the SBA resource on business insurance to learn the types of insurance available and what each type covers to determine what insurance you need.
Unique Requirements for Bio/Med Tech Ventures
- Regulatory approval is often required, e.g., Food and Drug Administration.
- You may need to make modifications to the product in response to obtaining regulatory approval.
- Health insurance reimbursement (for biomedical products) – Make sure that health insurance will pay for use of your product or the medical procedure for which it will be used.
(Manbachi et al., 2018)
FDA Resources – NCI SBIR Development Center
How to Get FDA Approval – Registrar Corp. 2021
3 Key Medical Device Reimbursement Challenges Manufacturers Face Globally – Infiniti Research
Breaking the Myths of Medical Device Reimbursement – MediClever Reimbursement Consultants
Health Insurance Coverage and Reimbursement Decisions – Issue Brief. American Academy of Actuaries. 2008
FDA Small Business Assistance – Includes:
- The Center for Biologics Evaluation and Research (CBER)
- The Center for Drug Evaluation and Research (CDER)
- Office of Regulatory Affairs (ORA) District Offices and Small Business Representative
Important Resource for Starting a Small Business
SBA has an extensive list of helpful resources including how to: