Healthcare is a global and ever-growing industry, especially as the world population ages. While this presents opportunities for medical device and equipment manufacturers looking to export abroad, numerous hurdles—differing healthcare systems, government bureaucracies, and product compliance—can be vast. Medical OEMs can overcome such hurdles by preparing and partnering with the right agencies and departments in their target countries.
Paying Providers: Private vs Public Healthcare
In sharp contrast to the US healthcare system, where funding is driven primarily through the free market like private health insurance (PHI), governments of many countries are the primary source of funds fueling their public healthcare system or PHS. In Canada, funding is gathered and shared between the provincial and federal governments. German and Japanese citizens support theirs through mandatory governmental health insurance. The UK offers a hybrid system in which the government covers most healthcare expenses, with PHI available for more coverage.
Navigating Exports Through Government Bureaucracy
Because the government is intimately involved in the PHS, original equipment and design manufacturers and sellers looking to export to those countries must determine which departments and agencies are involved in the decision-making process.
Unsurprisingly, these vary from country to country and even within a country's borders. As mentioned above, the Canadian healthcare system splits funding among its provinces. US healthcare computer sellers must approach each province separately and discuss their products' benefits and advantages, such as fanless design. Each may have a tier system of departments and agencies where one handles procurement while another handles the servicing of your products.
Under such a system, you and your staff may never directly work with the client like a hospital. To ensure you're able to find the right solution for the client, here are some of the questions you should be asking:
- What is the governing body or bodies where we must register our product to sell within the country?
- Which agencies or departments are involved in determining whether your product, like a medical box PC, is the right solution for the medical offices and hospitals in the area?
- What Vendor of Record (VOR) do you use? VORs are suppliers and service providers recognized and authorized by governments and corporations. In many countries, your company must be part of a VOR to have orders processed by the purchasing agency or department.
- Will products need to go through agencies or departments when they need servicing? If so, what are the names of those governing bodies?
- Do you have labeling and instructional requirements? If so, which agencies or departments will provide the details and forms? Examples include:
- Language requirements like English and French.
- Any Instructions for Use (IFU).
- Safety instructions.
- Product labeling specifics like types of barcode information.
- Any "green" initiative like the percentage of recycled material in packaging your products.
- What are the logistics costs? You should discuss shipping costs with each agency and department involved with your product. The costs can get hefty as Customs adds import duties and taxes to the figures, for example. You'll want to know who is responsible for payment, including even simple services like sending your products back to your facilities for servicing.
Medical Device Compliance Through Certifications and Licenses
Certifications are official documents that your medical device or equipment complies with a particular country's standards. They differ from each country. For example, "medical-grade" or 60601-1 in the US emphasizes fire safety. This is unsurprising, given that many buildings in the country use wood as a significant part of their construction.
On the other hand, Canada's medical-grade version, CSA C22.2 No 601.1, contains clauses ensuring that markings on its medical devices and equipment are not rubbed out or damaged by cleaning agents or disinfectants. Precise formulas of those substances are provided to ensure compliance.
Finally, medical-grade for Japanese medical devices and equipment (JIS T 0601-1) regulates power cord colors and materials as well as specific rulings on enclosure leakage current measurement.
A license legally allows you to market your products in that country and specific industry. Nearly every country has an official registration process for obtaining these valuable documents. The Medical Devices Bureau of the Therapeutic Products Directorate, Health Canada, licenses medical devices in that country, while the Therapeutic Goods Administration handles similar in Australia.
Successfully Export Internationally With Cybernet
Healthcare is a growing concern worldwide, and many medical device and equipment manufacturers are looking to expand onto new shores as a solution. However, each country has unique requirements, many of which are driven by public healthcare systems dominated by government agencies and departments.
Contact the team at Cybernet Manufacturing if you're looking to export your medical devices and equipment overseas. Team members will happily go over how our medical computers and tablets have been built from the ground up to meet global standards like IEC 60601. We have offices in EMEA, the Asia Pacific region, and Australia, with staff knowledgeable in the various government requirements and regulations in those areas.
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