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Wireless Compliance Consulting for Medical Device Companies

Many medical devices companies are adding wireless functionality to their products. However, many do not realize that this adds another layer of complexity to the regulatory approval process. Not only does the device need to comply with national health regulations published to ensure patient and user safety, they must also comply with issues related to use of the wireless spectrum in a specific country.

Medical device manufacturers whose products rely on wireless and mobile technologies must deal with these additional complex regulatory requirements. More often, manufacturers of medical devices with wireless functionality (such as Bluetooth) must now address information security and electrical safety requirements in addition to standard regulations in some countries. Emergo has assisted several clients achieve regulatory approval for their wireless medical devices, and can fully support your marketing authorization effort as well.

“Regulatory Roadmaps” for Wireless Technology Compliance

If you have already added or are considering adding wireless technology to your medical device, Emergo can identify pertinent regulatory requirements you will need to address in specific countries. For example, if you’re a wireless device manufacturer who has added radio frequency identification (RFID) to your product, we can point out requirements of given countries’ communications regulators such as the US Federal Communications Commission (FCC) in addition to standard medical device regulatory requirements.

As part of our wireless medical device technology consulting service, we can identify technical parameters including allowable frequencies, output power and other related issues associated with wireless and mobile products.

Registration of wireless medical devices

Once you have decided on which markets to seek approval for your wireless medical device, Emergo can prepare and manage your registration from start to finish. Our service includes support for spectrum or radio frequency approval from your chosen markets’ communications authorities, as well as for meeting requirements of medical device market regulators.

Please contact us for additional information on wireless medical technology consulting in specific countries.

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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. 

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Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Learn more here.