Build your BUSINESS in the
global markets
Introduction Regulatory Product Compliance is a critical part of achieving and maitaining market access for your product. Ensuring and proving that your products meetthe requirements, issued by the regulatory agencies of the countries where you plan to sell, is necessary to avoid your product being prohibited from that marketplace and the responsible parties for the product being fined or penalized. Ultimately this can involve: • Product Testing and reports that offer evidence of compliance • Certifications and Type Approvals – certificates issued that demonstrate compliance
Define your dependencies on other parties if you areusing any compliance affecting modules. come from your customers or be market driven, rather than legislation.
• Self-declarations – and other supporting documentation that may be examined when requested by a regulator Demonstrating compliance will also typically involve the use of certification marks or logos on your product and/or packaging and statements in the user documentation. Exactly what steps you take will depend on your product and the countries you are marketing to. Not dealing with compliance issues early on can result in a missed market or being too late to compete effectively or achieve premium pricing.
problems & Challenges
will cover some or all of the following areas:
• Product Safety • Electromagnetic Compatibility (EMC) Regulatory product compliance • Telecommunication or Radio-communication regulahas the potential to absorb tions significant time and can be seen as a diversion from the • Environmental or other regulations core objectives of the business, but getting the product launched ON-TIME with com- Over time these regulations do pliance demonstrated from the change and others may be outset will pay dividends in the introduced; so the challenges presented and presumably marketplace. solved for past products may Determining exactly which not apply going forward. The regulations apply to your intended use of the product may product can be very complex also change the scope of these and difficult without expertise in this area. Regulators in each regulations, for example devices used in medical systems or country have set specific environments may be subject to technical regulations for elecdifferent or further regulation. tronic and Information Technology products that need It is also useful to separate mandatory requirements from to be met in order to place products on that market. These those that are driven by marketing or customer requirements (as these may be negotiable). Some certification marks and logos are optional, or there are alternatives. You may want to consider some of these because they are either demanded by your customers or are highly recognized in the market and will help your product compete. As examples: • Many NRTL markings for product safety are available (CSA, MET, TUV, UL, etc.), but your market may favor one or some of these over others. • The WiFi CERTIFIED logo is owned by the Wi-Fi Alliance who set the rules for its use on products. While its use may be of benefit and achieve better sales, it would not normally be a mandatory requirement for market entry.
NuZeal Corporation is based in the San Francisco Bay Area and has been offering Product Regulatory Compliance expertise to clients for more than 15 years. Our network of experts has been offering guidance and certification/ approval services for a global market for many IT product types, including: • Short Range Radio Devices • Tablet and laptop computers • Cellular and portable devices • Consumer products • Infrastructure products – switches and routers
SCOPE Will depend on product functionality and countries involved.
COMPLEXITY
environments may be subject to different or further regulation. It is also useful to separate mandatory requirements from those that are driven by marketing or customer requirements (as these may be negotiable). Some certification marks and logos are optional, or there are alternatives. You may want to consider some of these because they are either demanded by your customers or are highly recognized in the market and will help your product compete.
Knowing what regulations you face can be difficult.
WHICH ARE MANDATORY? Some requirements may actually come from your customers or be market driven, rather than legislation.
As examples: • Many NRTL markings for product safety are available (CSA, MET, TUV, UL, etc.), but your market may favor one or some of these over others. • The WiFi CERTIFIED logo is owned by the Wi-Fi Alliance who set the rules for its use on products. While its use may be of benefit and achieve better sales, it would not normally be a mandatory requirement for market entry.
OVERCOMING THESE Challenges
and manage the schedule for this important area of work. Start by determining the scope of current regulations and what will apply to your product, and also make note of how each regulator will assess a requirements is met (the rules or process for Conformity Assessment). Will this involve product testing and/or applications for certification or type approval? Of course, information about your target market is critical here as the regulations vary by country. It may be useful to split these targeted countries into tiers so that
Planning Early How to demonstrate Product Regulatory Compliance can be very complex, and it is important to get an early start. Planning early is the foundation of a successful product regulatory compliance strategy. Knowing what regulations apply, and how to comply in your specific situation is extremely critical. Obtaining guidance early can allow a company to design products that meets latest and anticipated compliance requirements. It will also help choose or source components or modules that will shorten or simplify your complianceproblems for the finished product. Companies without sufficient in-house expertise should consider finding a partner who is experienced in this field and can help with complex web of rules and regulations. A preliminary review for compliance will identify the challenges ahead, determine aspects that will affect your design and help you establish a budget
the most important markets are addressed first and the regulations of a much smaller or less important market do not overwhelm your product strategy and design. The alternative to this early start strategy is to leave compliance for later and perhaps as an afterthought just before you plan to ship your product. This is risky when some regulatory requirements may need to be designed in or you need special engineering support or operational modes to get your product through compliance testing. This is also a high pressure time when further obstacles to product launch are unwelcome, especially when there is little time to overcome these challenges. Product regulatory compliance is a critical part of your development cycle and some thought should be given to this area from the initial stages and throughout product development. It will also need to be managed and maintained once a product is released and in the marketplace.
Developing and Executing a Regulatory Strategy The initial planning will feed into your design elements that will be critical for achieving and maintaining product compliance, allowing you
to incorporate the necessary features and design goals. It will also be critical for managing any aspects that are dependent on other vendors or service providers, especially when you are using modules and components from other vendors. If you are using ODM services you will be able to specify the requirements that affect product compliance at an early stage rather than be left with these problems to fix later. Other components that are often outsourced such as power supplies or AC adapters and telecom/radio modules will be critical for achieving your compliance goals and you can make the compliance requirements and the necessary support part of the deal being negotiated with these vendors.
Define your dependencies on other parties if you areusing any compliance affecting modules. come from your customers or be market driven, rather than legislation.
As your design phase progresses it is also necessary to expand your
Consider certification validity periods and the new for renewals or recertification.
compliance summary into a full strategy and plan. This plan will take into account the desired certifications that need to be applied for and the testing and documentation that will be needed to support them. This is also the time to decide on what responsibilities you are placing on your ODM or component vendors, how to leverage existing certifications for outsourced components and a plan for dealing with product families or similar models to identify any efficiencies that can be exploited. It is also important to consider how you will name your product from a compliance perspective and the branding that will be used. Most regulators are used to issuing certificates or approvals on a one model one certificate basis. You will
want to avoid certification problems because of later changes in model naming and use a consistent approach for model naming during your testing and certifications.
Achieving the necessary certifications and approvals Once you have a prototype product ready it is time to start the certification and testing phase of your plan, although it is important to have a design that is representative of what you intend to ship. Any compliance critical changes made will require further compliance evaluation or even retesting. It is also possible to have preliminary tests or reviews before submitting the product for formal testing to make sure you are on track. Testing and certification will usually start with the major and most critical
Use a model naming strategy that is consistent for your test reports, labeling and certificates. As part of its service NuZeal maintains information on spectrum allocation that identifies unlicensed bands that type approved devices can use.
aspects because this will typically be a prerequisite of later items. For example, with product safety testing it is common to complete a CB Scheme report that can cover many different country variations. It is also a good idea and more efficient to test for many EMC standards at the same time as some of the same test data can be reported for different countries. Product compliance will also have an impact on labeling and the documentation provided to the user. Some compliance marks are mandated on your product and/or packaging and statements that are necessary in the documentation. The exact content here is dependent on the exact plan and certification themselves (some require approval/ product specific identification numbers which you will not know until the certification is completed).
Use accurate and up-to-date spectrum information to ensure that your radio products always operate within allowed ranges.
You may also wish to keep some of the information regarding your product confidential, especially as the first certifications will be before launch. There is limited scope to do this but it is important to understand what is and is not possible if this is an important concern.
Maintaining Compliance Some of your certifications may be dependent of collection compliance records (sometimes called a Compliance Folder or Technical Construction File [TCF]), especially those that are based upon self-declarations. These records will need to be made available to the appropriate authorities on request within a short time period (a few business days) so you need to be prepared for this. Sometimes you will need to have a local entity (an importer/distributor or agent for the country concerned) have access to these records. Some certifications will also expire because they are issued with a set validity period. Sometimes these certificates can be renewed and in other cases it is necessary to recertify. You may also face new
requirements if the regulations have changed since your original certification was issued. There is also the possibility of market surveillance, where regulators will examine whether your product (as placed on their market) actually meets the compliance requirements. This can be due to random selection or complaint driven. This kind of action often strikes panic into your importers or distributors (since they often hear about this first) and it is often accompanied by the threat of penalties for non-compliance that can include removal of the product from the market and/or severe fines. If you have planned well, this panic is often unwanted and the issues can be resolved by dealing with the regulator concerned. The problems do not go away if ignored and the worst outcomes typically occur for manufacturers that are unwilling to open a dialog with the regulator. Radio products will also have the complication of dealing with spectrum management issues. It will be important for radio devices to correctly use the
spectrum that is authorized in each country and maintain compliance with the technical requirements for the band and application. This is true even for unlicensed (or Class Licensed) bands, since the lack of licensing just applies to the end-user not needing a radio license and does not absolve the manufacturer from certification requirements or helping ensure that the user meets all the spectrum usage requirements. Sometimes spectrum management will be integral to the certification process, in other cases less so. However, misuse of spectrum is likely to provoke surveillance activities, especially is your users happen to interfere with licensed operations.
Maintain good records ofyour product compliance, especially for those that are based upon declarations.
Your plan will help you start the critical testing and apply for certificates. Some countries will also have longer lead times especially if in-country testing is needed. US and European test reports are also used for many other certifications and approvals.