Medical device manufacturers are well aware of the benefits cellular technology can bring to their products. A cellular link, for example, can send patient data off-site to enable remote monitoring. Although cellular technology adds exciting new possibilities for healthcare, it also adds regulatory burdens. Despite these obstacles, the benefits of cellular technology outweigh the brief pain of certifying a wireless product, even in the most onerous countries.
Let’s explore the example of an imaginary medical manufacturer. A fictitious company, Saturn Medical, has decided to integrate a cellular modem in its product so it can monitor a patient’s vitals remotely. Saturn, a US company, wants to sell their product internationally. They would like to enter several countries immediately. What are the next steps?
Saturn must first outline the wireless certification requirements and processes in these countries. This sounds obvious but because requirements vary the earlier Saturn understands what is required the less likely it is to run into trouble. Also, understanding the requirements may determine if the manufacturer decides to add the cellular modem. Often, a manufacturer considers adding wireless in dozens of countries but ultimately proceeds with only a few. A look at each country’s cellular certification requirements offers a window into how product approvals vary around the world. Although these countries may seem like a random selection, they represent many others with similar processes.
Cellular certification in Indonesia requires the smooth navigation of a complex bureaucracy. SDPPI, or the directorate general of posts and telecommunications, oversees the certification process for wireless devices. Saturn must certify its end unit with SDPPI. It cannot certify only the modem. Indonesia also requires testing in country. Therefore, Saturn will have to send two full units of the medical device to the Indonesia.
Saturn must configure the two samples in accordance with Indonesian standards and testing procedures. This is the case for any wireless transmitter used in a medical device. Indonesia standards are generally not published in English but can, of course, be translated as needed. It is beyond the scope of this article to get into details of Indonesia cellular testing. It is important to note, however, that pre-testing in the U.S., to the applicable standard, is crucial. Any testing failure in Indonesia will cause significant delays. Shipping alone can take over a week and samples often must be cleared from customs. Saturn’s engineers should be prepared to speak directly with Indonesian test engineers in case the local lab has any questions on the test procedure or the modem itself. SDPPI will also likely ask for the IMEI (international mobile station equipment identity) number for the cellular modem during the certification process. They could also have questions about the SIM card, connectivity, or numerous other issues.
Many of the officials at SDPPI do not speak English and the approval process can appear murky to novice applicants. SDPPI does, however, have a long-standing system in place for cellular certifications and they are well organized. Still, it is important to have a bilingual partner in Indonesia in order to determine the status of the application. The language barrier alone can be a show-stopper. Saturn’s partner should be familiar with the certification process so as not to constantly barrage SDPPI with questions. They should have a realistic timeframe for how long each step takes and know that SDPPI does not always alert the applicant the second there is a delay. One must follow the procedure carefully and determine any obstacles without becoming an annoyance to the regulators.
United Arab Emirates (UAE)
If Saturn Medical decides to sell its wireless medical device in UAE, it can prepare for a stress free type approval process. Despite its relatively small size, UAE is a major market for U.S. exporters. The Telecommunications Regulatory Agency (TRA) oversees spectrum affairs and type approvals for wireless devices. The certification process is clearly outlined in published TRA documents, in English, and the regulators often respond quickly to questions. Many TRA officials speak and write quite well in English. UAE will accept test reports to European standards. They have, however, recently begun to require a sample for in-country inspection. That is not a typo; in international approvals we should distinguish in-country sample inspections from in-country testing. The TRA typically completes a visual inspection only and Saturn can avoid the hassle of configuring its sample to unique country configurations. Still, the question arises if the manufacturer must send a complete ‘end-unit’ or just the modem itself. For UAE type approval, Saturn can send a sample of the modem only. The applicant can expect to complete the certification process in about two weeks from the time the sample arrives and the TRA receives all documents.
First time applicants must also complete a one-time ‘brand registration’ with the TRA. In our hypothetical situation, Saturn has never approved a wireless device in UAE. Therefore, Saturn will need to register its brand with UAE. In many cases, the brand is simply the company name but there are always exceptions and Saturn should know in advance which brand name it would like to operate under in UAE. All of this, of course, assumes Saturn is registering the modem in its own name. We will address this in the concluding section. The brand registration process takes about a week and requires minimal effort from the applicant.
Wireless Approvals in Paraguay are administered by CONATEL, Comision Nacional de Telecomunicaciones. The regulatory approval process is straightforward and although it takes several weeks to complete, requires minimal effort for the applicant.
Saturn must have an in-country representative in Paraguay. This is not unique; for the registration of cellular modems, many countries require that a foreign applicant has a local office or affiliated partner. This can be an international office, supplier, or even a third party set up to provide the local representative service. For Paraguay, Saturn will need to provide a power of attorney letter to its local representative. This letter must be notarized by the nearest Paraguay consul in the U.S. If, however, Saturn decides to use a third party approval service, that provider will likely already have a registered in-country representative. Saturn may be able to avoid the hassle of sending documents to the Paraguayan consulate. Paraguay has recently begun to tighten these requirements and further steps may be necessary for authorization.
Paraguay does not mandate testing in-country and will instead accept international test reports. This is also not unique; while some countries, like Indonesia, require local testing, many others, if not the majority, will allow FCC or European (R&TTE) reports as part of the application package. In this case, Saturn can submit FCC or R&TTE reports for the modem to Paraguay. The test reports often come from the modem manufacturer. It is important that Saturn check with the manufacturer of their modem to see what testing has already been done. Ideally, the modem will have already undergone FCC, European and possibly testing for other countries. The application for Paraguay typically takes 8 to 10 weeks to complete. Once Saturn submits the application, they need only to follow up on occasion and wait for it to go through CONATEL’s queue.
Saturn can likely avoid wireless registration in India altogether for their cellular modem. The service provider of, for example, a 2G/3G modem, may already have the necessary registrations in place and further approval would not be necessary. For a non-cellular short range device (SRD), the registration process in India is generally quite simple. The manufacturer can submit test reports to European standards to the Wireless Planning Coordination (WPC) wing of the Department of Telecommunications. A local representative is required for the submission process and the review usually takes four weeks to complete before the authority issues type approval. Although Saturn may not have to complete this for their cellular modem, it helps to understand the processes in place and the relevant authority in a given country. Further, if Saturn decides to add other wireless transmitters in the future, they will already understand what regulatory hurdles to meet.
As long as the cellular modem does not transmit voice, it is exempt from certification with the Comision de Regulacion de Telecomunicaciones (CRT). Bluetooth, 802.11 and RFID are also exempt from certification assuming they are operating in accordance with Colombian frequency allocations. Saturn may want a voluntary letter of exemption from the CRT confirming the device is exempt. This could be for Saturn’s internal due diligence or to prove to a customer the device is acceptable for use in Colombia. The CRT is usually quick to respond and issue a letter of exemption. They do not charge for this service. It is helpful to send them a few documents for review, including the product specifications, and the FCC/TCB Grant. Saturn does not want to burden the CRT with too many documents as this may slow the review process.
Wireless certification for South Korea can be intense and time consuming compared with many other countries. Yet, Saturn should not let this stop it from entering a major international market. Korean approval is achievable. The cellular modem will require MSIP, ministry of science, ICT and future, certification.
Korean approval for a cell modem is a multi-faceted project. Saturn will need two samples for testing to Korean standards. One sample should be configured for conducted testing and one for radiated. It may be possible for Saturn to avoid sending complete medical units. Testing can be performed on the wireless card if it has the right casing. If not, EMC (Electromagnetic compatibility) testing will need to be performed on the end-unit because without the casing electrostatic discharge could damage the wireless card. In addition to EMC, Korea will also test for RF emissions and product safety. Saturn will need to provide detailed documents on the modems like block diagrams and schematics. Occasionally, a cellular manufacturer will be hesitant or even refuse to share these types of materials with the medical manufacturer integrating its modem. Saturn must confirm that the modem manufacturer will be willing to share these items before starting the Korean approval process.
If Saturn is using a modem with multiple interfaces, it is important to note that Korea has restricted GSM. Saturn should check for similar restrictions in other countries, which may emerge in coming years. Korea also requires a local representative and the user manual for the product must be in Korean. If Saturn properly configures samples, and works with a competent partner in Korea, they can approve their modem in as fast as four weeks. The process, however, often takes longer—especially if questions or failures arise during testing. Although it can be completed faster than Paraguay, it requires more hours of effort from the applicant.
Although these countries look like a random selection, they illustrate several themes one can find around the world. This article deals with a hypothetical situation of a medical manufacturer incorporating a new modem. It assumes the modem manufacturer did not have type approval in any of the aforementioned countries. A manufacturer should always attempt to leverage existing approvals, where possible, from their supplier. When the modem manufacturer does not have any approval in a country that requires end unit approval for any wireless product, even medical, the manufacturer most often must obtain approval on its own.
For medical devices, the ‘end unit’ is often expensive and the manufacturer cannot always be certain it will be returned. Therefore, one must determine if the modem alone is sufficient for in-country testing or in-country inspection. Cost is also a major consideration. If a medical manufacturer is looking to use a third party to help with its wireless registrations, it should contact more than one provider to compare quotes, response time and quality of service.
A medical manufacturer must also confirm that the vendor of its modem is responsive and helpful. The required documents vary across countries. The applicant may need to submit sensitive information such as Schematics or Bill of Material (BOM). Even basic items such as test reports can be hard to obtain if the modem manufacturer is unresponsive. Therefore, one should speak with the modem manufacturer or meet in person to determine they will be an engaged partner during the certification process.
Medical manufacturers are often used to complicated regulations and bureaucratic procedures. Now, they have to deal with wireless registrations. Many who have gone through the medical regulatory process, however, insist that wireless registrations are easier and more straightforward. Of course, it will depend on the product and country. But, for the most part, if you can conquer a medical registration you can conquer wireless.
Michael Cassidy is the founder of MC Global Access LLC (MCGA). He lives in Menlo Park, California. Prior to forming MCGA, he was the operations manager for TUV Rheinland’s international approvals group. Michael also worked as project manager with Intertek’s global market access program. He has worked with a variety of clients and obtained product certifications in over 100 countries.