How To Start A Medical Appliances Export Business?
Starting your own Medical Appliances Export could be a lucrative option. Today, machines involved in operations costs a lot of money to set up.
Medicine has evolved like never before. From surgeons operating on non-anesthetized patients in ancient times to today’s surgeries requiring different levels of anesthesia, modern medicine has given a lot to human beings and animals alike. Modern medicine has helped people lead better lives by discovering various methods for surgeries for childbirth, removal of tumors, fat and diseased parts, organ replacement, brain surgery, heart surgery—the list is endless. Needless to say, high-end equipment is required by the Medicine/Hospital industry to set up hospitals and clinics. Medical devices vary greatly in complexity and function.
Looking To Make A Name As A Medical Device Exporter?
So if you are looking to make your name as a Medical device/appliances exporter, you are in for some serious buck. But don’t forget the standard for such appliances is really high and the export of such appliances is controlled by the export/import department of each country. The regulatory authorities recognize different classes of medical devices based on their complexity, their characteristics, and their possibility for harm if misused. Each country/region defines these categories in different ways.
Classification Of Machines And Getting Approvals
First, you need to classify your device. For this, you can go to the Classification database online and find the particulars. Once you find the classification for your device, you can import/export it under that classification. Your machines may range from simple devices like thermometers or scalpels to more complex machines like diagnostic equipment like imaging equipment and monitors, medical laboratory equipment, and anesthesia machines. According to the U.S Food and Drug Administration, there are three classifications:
Class I General Controls
- With Exemptions
- Without Exemptions
Class II General Controls and Special Controls
- With Exemptions
- Without Exemptions
Class III General Controls and Premarket Approval
The class to which your device is assigned determines the type of premarketing submission/application required for clearance to market, amongst other things. Each and country has its own set of rules and regulations when it comes to exporting medical devices.
Many good established hospitals typically have their own Operating Room Purchasing and Materials Management staff. Contact their department and find out what their requirements are. Establish contacts with medical machinery retailers as well.
India’s medical equipment market—valued at $2.7 billion in 2008—is Asia’s fourth-largest (behind Japan, China, and South Korea) and is projected to reach $6 billion by 2015, as health insurance becomes more widely available and the country’s middle-class consumers continue to demand better healthcare services. India is one of the biggest destinations for medical tourism. To encourage medical tourism, the Indian government now issues special “medical” visas for medical tourists (in order to expedite entry into the country) and has established public-private partnerships to build highly specialized medical facilities in cities such as New Delhi.
India hosted an estimated 450,000 medical tourists in 2008. In India, cardiac surgery or Kidney transplant would cost much less than what it is in, say, UK. This makes India a hotspot for medical tourism. Sources: “India: Healthcare and Pharmaceuticals Report,” EIU, November 12, 2009; “Healthcare in India,” PriceWaterhouseCoopers, 2007; “India’s Device Market Defies the Recession,” Medical Device Network, August 13, 2009; “India, World Diabetes Capital,” Hindustan Times, May 4, 2010; “Medical Devices Industry Assessment,” USDOC, March 2010.
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I am a U.S. Certified Export Compliance Officer with over 10 years in export compliance and even more experience with specialized CNC machine shops. I am interested in any other information regarding how to start a medical device export business. Send me more information if you have any and I will contact you.
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