To be able to market their products in multiple countries, manufacturers and importers must ensure the conformity of these products with the relevant regulatory framework as well as with the national requirements of the countries in question. Over recent years, significant progress has been made towards harmonising such requirements and the mutual recognition of conformity tests and certifications, with European and North American standards being taken as the starting point for this process.
Even so, the formalities required by individual countries differ greatly, which proves problematic when it comes to managing global conformity programmes. These wide-ranging requirements relate not only to the technical specifications that must be met, but also to the specific paperwork and procedures required to obtain regulatory approval at a national level.
As such, navigating the regulatory landscape to obtain global market access for electrical and electronic products is an immensely complex task for those charged with product quality and sales. This is why many companies miss out on internationalisation and wider market access.
This document is a practical guide to managing global conformity programmes.
Be realistic and restrict your target markets
Being over-ambitious can lead to problems when it comes to running conformity programmes for global market access. It is essential to define precise, realistic objectives regarding the countries you are aiming to access in the short, medium and longer term, carrying out a detailed cost-benefit analysis of the formalities involved.
Identify the conformity requirements applicable to the product and target market in question
Requirements relating to electrical and electronic products fall chiefly into the following categories:
- Electrical safety: ensuring that the product poses no danger to consumers by minimising electrical and mechanical risks
- Electromagnetic compatibility: ensuring appropriate levels of emissions of, and immunity to, electromagnetic fields
- Radio: ensuring an appropriate use of the radio spectrum
- Energy efficiency: ensuring that the device uses energy efficiently
- Other: sustainability and recycling, use of materials, use of chemicals, etc.
In each of these fields, requirements can differ vastly from one country to the next. Something that is mandatory in one market may not even be regulated in another, and vice versa. As a general rule, electrical safety and radio requirements are those most commonly regulated.
Conformity assessment process
Even when a particular field is regulated in a number of countries, the conformity assessment process can vary widely.
- Unregulated (Bangladesh)
- Conformity testing against an internationally recognised standard (Paraguay, Colombia, Morocco)
- Approval of product documentation and testing reports by a local body (Saudi Arabia, Turkey, Russia)
- Mandatory quality mark granted according to national or sector standards with testing undertaken only by recognised laboratories (which may include foreign laboratories). The involvement of a certification body may or may not be required (European Union, United States, Canada, Japan, South Korea)
- Mandatory local quality mark granted following testing by local laboratories (Brazil, China)
Some countries may enjoy the specific requirement of having a legal representative in the target market country, which is in fact unrelated to that market’s conformity assessment process.
In the field of electrical safety, the CB Scheme provides a conformity framework based on mutual recognition that is accepted by most countries. This scheme sets out a package of basic tests that apply to all countries belonging to the scheme, plus a list of “national deviations”. In this way, a product’s electrical safety conformity can gradually be broadened, with test reports reusable in new markets.
In countries with an unclear or not-yet-fully-developed regulatory framework, local authorities enjoy a fair amount of discretion over the criteria involved in validating product documentation. It is vital to bear this in mind as it may have time and cost implications when seeking the requisite approvals.
Finally, it is also important to consider the more idiosyncratic requirements that may be in place in a given market. While not set out in law, these carry great weight and cannot be circumvented. Some examples of things that could sit in this category are insurance company requirements or deeply entrenched voluntary marks.
Turn to experts in international regulation to manage your product conformity
As we have shown, identifying the relevant international requirements and certifications and managing the necessary approvals and documentation demands an in-depth knowledge of the regulatory landscape.
Often this information is not publicly available and can only be acquired by getting in touch with a country’s supervisory body. Cultural factors also play a part as there are certain countries in which the importance of personal, face-to-face contact cannot be overstated.
It is therefore indispensable to turn to experts in regulation, testing and certification, such as Applus+, who have the capacity to manage global market access programmes. Our experts will help you assess the costs and opportunities involved in accessing a particular market and will take charge of managing the process.