Frequently Asked Questions
Which countries require wireless certification for medical devices using wireless technology?
Almost every country and all major markets require wireless certification. Popular markets like China, Korea, Japan, Mexico, and the USA all require certification for most wireless products.
What does the wireless certification procedure entail for most countries?
The details vary from country to country. Some countries will require local wireless testing, meaning they won’t accept test reports from other countries as part of the application process; the applicant must send samples to a local lab, in country. This is often a government run lab or a lab closely affiliated with the government. Emergo has strong connections at these types of labs across the world.
Other countries will allow foreign test reports as part of the application process. This means that a manufacturer can test the product to FCC (USA) or European standards, depending on the country, and submit those reports as proof of acceptable wireless performance.
Is a local representative required for wireless approvals?
Many countries require a local representative for wireless approval. The application must come from a business registered in the country and with the wireless approval body. Emergo can provide this service as needed in dozens of countries.
How long does it take to obtain wireless approvals?
Generally, the procedure is much faster than medical approval, but it can vary greatly. Some countries take three months while other take only three days. Most major markets take approximately eight to nine weeks for approval, assuming everything is in order when the applicant submits documents and samples to the regulatory body.
Are wireless frequencies harmonized across the globe?
Generally, it is best to check the wireless spectrum of each market. Harmonization exists across countries for certain technologies like Bluetooth, but for others, like RFID, the manufacturer will find different frequency allocations, allowed output powers etc. In those cases, a wireless transmitter used in Mexico might not be allowed in China. We recommend the client check the technical parameters for any country of interest as early as possible, ideally before even integrating the wireless transmitter into the product.