International Wireless Approvals: An Overview for Medical Device Manufacturers
Medical device manufacturers interested in selling their wireless products internationally face two sets of regulatory hurdles: medical and wireless. Medical devices using wireless components must be approved by both medical and wireless authorities in most markets.
The authority overseeing a country’s radio frequency (RF) spectrum or communications infrastructure typically makes the rules for wireless products in that country. Some rules are simpler than others, but knowing those rules in advance leads to more efficient market access—specifically, knowing what the rules mean for your device. The principal factors to grasp are lead time, technical parameters and cost. Knowing these factors can help avoid surprises and delays as you make your global product launch.
Different countries can have vastly different lead times for wireless medical device approvals. Some market regulators will approve wireless devices in days or weeks, while others can take months. Typically, though, wireless approvals go faster than medical approvals. Some market regulators require testing of your device at local laboratories, which involves shipping products to testing sites, going through customs, actual testing and then preparing test results. Unnecessary delays, however, can be avoided through efforts such as knowing your test parameters and preparing all necessary documents ahead of time.
Chief among technical parameters to bear in mind are frequency and output. What you may think of as a license-free frequency may require certification or approval in certain medical device markets. You should not assume that the frequency and output power your device uses in one country will be automatically allowed in another—always check the regulatory process for telecommunications equipment when entering a new market.
Costs to obtain regulatory approval for your wireless device vary from country to country. Countries that require local product testing tend to have the highest market entry costs; manufacturers expecting to sell a limited number of devices may want to seek markets with lower regulatory costs.
Michael Cassidy is Senior Consultant, Wireless Compliance at Emergo Group.