If you are interested to start the durable medical equipment business, let me tell you this is a right time. Medical equipment business industry is growing rapidly .Changes in technology, need of innovation, new regulations and government’s self- reliant approach towards the industry are the few supporting factors for the growth. India is dependent for importing medical devices, to reduce dependency government working hard and launching new schemes like medical device park, PLI and other and also providing financial help for the start ups. so it is really a time to grab the opportunity. If you want to start a durable medical equipment business it is advisable to go through with regulations and understand the market for the business.
- If you stuck with the regulation or if you want to classify your medical device we can help you in the process. For more than 10 years we are working for medical device regulatory consultant and compliance services .To taste the success contact us now or you can whatsapp us your details we will answer you shortly.
What Is Durable Medical Equipment (DME)?
The Durable medical equipment are any medical equipment which can be used at home to support the better quality of living. The aging population and the patient’s desire to receive a home care fuel the market of durable medical equipment. These are the equipment:
- Which used for medical purpose
- Durable
- Can be used at home
- Useful for injured or sick people
So the Durable medical equipment help in daily activities and it includes the variety of items such as wheelchairs, diabetic testing kit ,walker ,portable oxygen, Nebulizers, blood sugar test strips , hospital beds, commode chairs etc. While doing durable medical equipment business and selling these products into market manufacturer or supplier need to check regulations associated with them.
Few points to consider while doing Durable medical equipment business:
- Licensing requirement: The requirement for DME wholesaler and for DME retailer are not same .if you are DME wholesaler means you are supplying medical devices and supplies to retailers and to the other organization like hospitals ,pharmacist, Medical practitioners etc . If your intention is to ship your equipment in or out of state you will be in need of license from regulatory body of governing state . laws may differ according to state .To apply for a license in general you will need
- Information about your company.
- Description of product you sell.
- Facility inspection report
- Many other documents .
For more details on licensing process and documents you can visit our website and can contact to Operon strategist team who can guide you in all aspects .
If you are retailer you will be in need of license according the state. Even certified pharmacies might also require extra licensure specific to the sale of DME products.
DME Compliance:
The federal government conducts strict oversight of Durable Medical Equipment groups thru the U.S. Department of health and human services workplace of inspector general (HHS-OIG) and the facilities for Medicare and Medicaid offerings . Compliance with federal legal guidelines and regulations requires the implementation of a system of assessment for all advertising and marketing and billing strategies. Commonplace violations contain billing practices, referral fees and kickbacks, and advertising and marketing transgressions. To assist ensure compliance, the HHS-OIG has advanced a series of compliance program guidance files for hospitals, nursing homes, DME providers, and more.
To start Durable medical equipment (DME) business few steps to remember:
- Understand the Industry
- Market research and feasibility studies.
- Major competitor in the industry.
- Economic analysis.
- Study of Threats and challenges.
- Necessary legal documents.
Some states may require licensure for the distribution of medical devices, although the devices aren’t taken into consideration DME specifically. Again, it is important to verify the licensure necessities of your own home state and any nation in that you plan to operate earlier than starting to do business. Durable medical equipment .DME market is large and growing and profitable too .Increase in aging population and the need of serving more patients at home increased the demand of DME. To start the business you need to complete the regulatory process, operon strategist medical device consulting help manufacturer ,importers and exporters in regulatory and licensing process. We provide cost effective services to our clients and walk with them in their journey of success!
