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Wireless Compliance for Medical Manufacturers 101

Integrating a Third-Party RF Module in a Global Market

As a medical manufacturer, you may be adding a wireless component to your device for the first time. Perhaps you have an existing model and you’re excited to finally ditch the cords. Even if you’ve used wireless technology for years, you may need new capabilities or be looking at a new RF module supplier. In each of these scenarios, you should apply similar guidelines to streamline your international compliance efforts. While numerous technical and operation aspects — from engineering to costs — of integrating a third party module into your device will influence your decision, this article will focus on global wireless compliance. More specifically, it will discuss what to consider if you intend to certify your device with an integrated third-party module internationally.

This article is geared towards medical device manufacturers. They may be new to global wireless requirements (although they have dealt with a number of regulatory issues). They may also not have established, longstanding relationships with a third-party module manufacturer. In that sense, we can look at their module integration as a fresh start. One can, however, still apply the following lessons to other device categories, such as consumer or industrial products.

Where You’re Going

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Sales opportunities come and go at different rates depending on the industry, economy, and countless other factors. It can be difficult to evaluate opportunities in distant markets. Once your team has developed a list of potential countries to enter, you can begin to understand the compliance efforts needed for each country. This will dictate what you need for the third-party module manufacturer. If, for example, you intend to sell the wireless version of your device only in the United States, there are fewer compliance hurdles. It is safe to say that most RF modules will have FCC certification. However, if you are considering a global launch, hitting major markets in Asia, South America, Africa, and Europe, for example, there is more to consider.

Ask your potential module supplier for a list of countries in which their unit has been certified. This may sound obvious but too often it isn’t considered until after the supplier has been selected, and knowing the answer in advance could help when deciding between two suppliers. If, for example, you are integrating Bluetooth into your medical device and have the choice between one Bluetooth module manufacturer who has approvals in several countries and one with approvals in none, this should influence your decision. While the final decision will depend on a variety of additional factors, a manufacturer should nonetheless investigate this issue early on in the evaluation process.

Modular vs. End System Wireless Certifications

Global market access or international certifications for all wireless devices, including medical devices, are often casually discussed in terms of “modular vs. system level “approval. At it’s most basic, this issue is generally framed as follows:

“If I want to sell in a country X, do I have to approve my end unit, a medical device, with the wireless authority? Or can I just use an approved Bluetooth module, purchased from a third party, and integrate it into my device?

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If the latter is the case, then you might follow up and ask:

“If I’m using an approved Bluetooth module, are all devices that use the module now compliant? We have several versions of our units. Since they use the same module and the country only requires approval of the module, in effect we approved them all, right? Therefore, if my Bluetooth supplier already has wireless approval, is my work is done?”

This line of thinking will help frame your strategy towards wireless compliance but the details and idiosyncrasies of various markets complicate the picture. The goal is to understand how an RF module’s regulatory certifications will impact your compliance efforts.

Although a good starting point, asking if a country allows modular or system level approval risks over-simplifying the compliance roadmap. For example, you may reach out to a test lab that will send you to their international approvals group. You’ll ask a project manager “we saw on our RF module manufacturer’s website they have wireless certification in country X.” The project manager will glance at the country’s profile and respond, “yep, you’re good to go. Country X allows ‘modular’ approval.”

While this is undoubtedly good news, there may be additional details that remain unanswered. Therefore, you should follow up with the following questions:

  • Where does it say modular approval is sufficient? Do you have a copy of the country’s law stating this?
  • Co we need to register our company or brand name with the wireless authority?
  • Does our importer need to be on the certificate?
  • What about the labeling?
  • Do you we need permission to use the certificate from the module manufacturer?
  • Does the medical application of the device restrict or impact the RF/Wireless application? For instance, are there restrictions on sending medical data?

While a certified RF module may not always be sufficient, it will often help. There are instances where the government telecommunications approval body will need to evaluate the EMC and safety aspects of your medical device. Once they see you are using an approved integrated RF module, they may wave RF testing requirements, saving cost and effort. You may still need to certify your medical device with the government agency or authority, and could even need to test to EMC/safety standards in country. By choosing a certified module, you’ve greatly reduced your workload.

What You Need From the RF Module Supplier

When establishing initial communications with an RF module supplier, provide them as early as possible in your discussions with a list of items that you’ll potentially need. I stress the word “potentially” because the response you receive could determine whether or not you use that supplier for the RF modules in your device. For example, if you approach an RF module supplier with a list of items, and they ignore you, equivocate or state they don’t provide that information, consider another vendor. Some RF module manufacturers will provide a login to request items. Others may assign a sales person or project manager to answer your questions and requests.

The documents you require from an RF module supplier ultimately depends on the destination countries. There are, however, some standard items if you are seeking wireless compliance on multiple continents. You will need test reports that verify a module’s compliance with current European (and/or U.S. FCC) RF, EMC and safety standards. You will also need basic documents, such as user manuals, possibly translated to various languages, and data sheets.

Some countries will require authorization from the RF module manufacturer. These are often a statement that your medical device can use the RF test reports as part of your application for wireless compliance (or something along those lines). Some RF suppliers will promptly review these authorizations while others will run them through a vast network of internal lawyers. Then there is the big ask: circuit diagrams/schematics. The RF module manufactures are often reluctant to provide this information and, in a few instances, it will be unavailable. You want to know right away if there will be a potential problem.

You may also need samples of the RF module to test in a given country. The in-country testing details could cover several articles, but suffice it to say that most medical device manufacturers prefer to test the RF module alone since it is less expensive than an entire medical device.

Many countries do not require local testing. Of those that do, some will allow an applicant to test only the RF module. Even in some cases where the end unit will be certified, the certification body may just need to see the RF performance of the module. There are also cases where government-affiliated labs don’t even test the module, but simply inspect it. You should always verify the local testing procedure and crosscheck with your RF module vendor that the module will not only meet the standards but also comes with the necessary support equipment, software, and translated instructions.

General Restrictions for Use

Before integrating a third-party module, you should check that the module meets the technical specifications of the countries you intend to enter.

Since this is often not an issue, it is easily ignored; however, one must consider it early in the integration process. We can say it’s not often an issue because many technologies and frequencies are harmonized (Bluetooth is an obvious example), and the spectrum applicable to industrial scientific and medical (ISM) devices is practically universal. You may also be able to adjust the frequency of your module to meet country specifications. For example, cellular modems can typically be modified to operate within a country’s designated spectrum.

However, there are instances where an RF module may be incompatible with national wireless regulations. The frequency could be unavailable or allocated for a different purpose. Or regulators may stipulate an output power level that is too low for your intended use. You could be using the wrong modulation or channel bandwidth.

Often, only one or two countries, out of dozens in global product launch, will have technical legislation that prevents certification. In such circumstances, a manufacturer may choose to not sell the wireless version of its medical device in these countries, or may look for an entirely different module if a given market is extremely important. Too often a sales person will find an opportunity in a new market (typically, a positive development for any manufacturer), only to learn the product cannot be used in that country under its existing specifications.

As always, the key is to know early. An open dialogue with the module manufacturer can also be helpful. Ask if they sell other models in the market where the primary model is restricted. Check what their other customers have done, if anything, for a substitute.

Restrictions on the Module as a Medical Application

Medical manufacturers should ask if there are limitations on how they can use the wireless module. For example, can the device send medical data off-site? An increasingly interesting question is which authority has jurisdiction over a given device. Does this fall under the wireless/telecommunications authority or medical/health body, or is there joint jurisdiction?

In general, national telecommunications authorities still dictate all things wireless including specific absorption rate (SAR) requirements. The proximity to the body, frequency and output power are more consequential to the regulatory decision than the use. That is, it often seems they don’t care if it’s medical or consumer; they are looking at the numbers. Nonetheless medical manufactures need to be acutely aware of SAR requirements and determine if the performance of an integrated module meets country specifications.

One should also investigate who owns the wireless certification of an integrated module. As mentioned, the module manufacturer ideally has as many country certifications as possible. The device may be compliant, but the question remains: do we need to transfer the certification to our medical company, the importer or the end user?

Take the example of on-site paging at a medical facility in a European country. The device may be fully-compliant with EU’s Radio Equipment Directive, but the end user at a medical facility would still need to register the device with an individual EU country in order to operate on specific frequencies.

To take another case, your importer or distributor is bringing a medical device with wireless technology through customs. Can he simply show the certificate, which is issued to the wireless module manufacturer? What if the certificate is issued to local representative for that manufacturer, an entity with no ties to you? There are cases where this is still acceptable. The device is compliant with wireless regulations and that’s enough. Importers will often say they want to transfer the certificate to their name anyway to ensure a smoother process. Customs isn’t always on the same page as the wireless authority and now you are adding in the medical body too. So, despite what the wireless regulations say, it’s often wise to listen to your importer as well.

Often, medical and wireless regulatory bodies are almost completely separate, especially in second or third tier markets, and there is little to no coordination between them. We can look at the United States for signs this could change. Increased coordination between the FCC and U.S. Food and Drug Administration (FDA) seems to point to increased regulatory attention to wireless transmission in medical applications. We could see this expand to other countries, especially with issues such as privacy in medical data and wearable devices.

While these issues pertain more to the general convergence of wireless and medical regulatory, as they develop they will impact specific considerations for your module. The key is to understand the regulations for each market, evaluate potential module suppliers and start the compliance process as early as possible in product development cycle of your medical device.

author_cassidy-michael-2Michael Cassidy has been involved in international compliance since 2007 when he started as a project manager with Intertek. Michael moved to TUV Rheinland where he was operations manager for their International Approvals team. He then formed M.C. Global Access LLC which helps medical, consumer, and industrial manufacturers certify their products overseas. Michael can be reach at mcassidy@mcglobalaccess.com. 

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