Global market access requires businesses to navigate a complex web of international, national, regional and even local regulations, requirements and mandated protections.
This complexity challenges even the most sophisticated of companies as more players, demands and options result in more angles to consider, understand and manage.
Bottom line? Because everyone seems to want something different, forming and maintaining an effective business development strategy has become more difficult, not less, with modernity.
UL’s team of Global Market Access experts wants to help you make sense of the global marketplace. They’ve assembled the basic information that every business needs to know to achieve its strategic objectives.
The stakeholders
For a business to grow, it needs to keep innovating. Embracing new markets is one form of innovation. However, this requires fortitude, knowledge and a clear understanding of six key compliance stakeholders.
Code Authorities – Regulatory authorities are agencies acting under power granted by a government. They enforce statutes, develop regulations and assist the public with regulatory compliance. Not every agency is equal, though. Some agencies have broad control, while others are more limited. U.S. Customs and Borders Protection Agency, the State Administration for Market Regulation in China, and Brazil’s National Institute of Metrology, Standardization and Industrial Quality are examples of regulatory authorities.
Industry special interest groups (SIG) – SIGs bring together individuals interested in common technical challenges in an industry or specific technology area. Many SIGs — Bluetooth®, Thread and EMVCo are a few examples — develop their own protocols, testing programs and qualification processes for market access.
Conformity Assessment Body (CAB) – Conformity assessment bodies offer the certification of products, processes or services as a means of assuring that they comply with specified requirements in standards and other normative documents, which may be mandatory or voluntary. CABs offer third-party conformity assessment services such as testing, inspection/auditing and certification.
Standards Development Organization (SDO) – An SDO is an organization that facilitates the development of standards and publication of standards.
Standards Technical Panel (STP) – An STP is a group responsible for developing and revising a standard or group of standards.
Technical Harmonization Committee (THC) – A group responsible for developing the proposed draft of a harmonized standard, specifically focusing on technical requirements to be included in the harmonized standard. The group consists of an industry representative of each involved country and representatives of involved SDOs, if applicable.
The challenges
Whether expanding globally or managing the fluidity of current market demands, doing business always demands fortitude. According to our Global Market Access team, the list below represents the common challenges businesses face today.
Growing uncertainty around regulatory compliance
Market uncertainty is growing as regulatory interest in technologies, such as the Internet of Things, autonomous vehicles, electric vehicles and concerns around consumer privacy, data protection and environmental protection increase globally. Many companies are worried that regulations will take precedence over innovation.
Keeping up with regulatory changes
Each country passes and enforces its own laws and regulations governing business. In some cases, laws and regulations can be tied to regions, provinces or even continents, such as regulations passed by the European Commission. What isn’t as well known is how often requirements change, regardless of when, where or who passed the law.
In a review of regulatory changes over an 18-month period (January 2020 - June 2021), UL’s Global Market Access team found more than 1,300 changes impacting products and conformity assessment schemes — that’s roughly 2.3 regulatory changes per day! However, tracking these changes and understanding how they apply to your business can be challenging. These fast-paced shifts can leave many companies struggling to catch up and surpass competitors.
Note: Data taken from regulatory news affecting UL’s Appliances, HVAC and Lighting (AHL) and Consumer Technology divisions for the period stated above. The current average for the same industries was six changes per day between August and September 2021.
Lacking in-house expertise
Whether you’re adding new products or distributing to a new country, globally expanding your business becomes more complicated with each subsequent expansion.
Unfortunately, compliance layoffs and budget cuts due to the global pandemic have stretched compliance programs, with nearly 40% of respondents in the AlixPartners 2020 Global Anti-Corruption Survey reporting budget and/or headcount reductions to corporate compliance programs.
Furthermore, the current compliance job market remains challenged by labor shortages. Reuters reported on Aug. 26, 2021, that “debates over remote working and return to office plans have added a new variable in compliance hiring.”
When we combine the ever-increasing regulatory environment with a lack of qualified regulatory compliance employees, many companies are left struggling to act upon regulatory obligations.
Overlooking local insights
While internal knowledge is valuable, local market knowledge is often far more helpful. Not having local insight into the market can make it difficult for companies to interpret or even estimate their regulatory compliance lead times. Moreover, regulatory compliance usually requires product notices — labels and Safety Data Sheets — be written in local languages.
The solution
Regulatory risk in terms of additional laws and changing regulations will never go away. As the world gets seemingly smaller due to advanced communication and transportation technologies, building up your market intelligence becomes even more critical to achieving global market success.
Whether a global market novice or internationally savvy, incorporate these four solutions into your market access strategy:
- Learn more about your market destination – Research the size of the market, the competition and the country’s regulatory compliance requirements.
- Partner with a company experienced in global market access – They’ll have the knowledge, contacts and experience to help navigate global compliance complexities.
- Leverage data solutions – Businesses have a better chance at meeting compliance requirements if they invest in the proper tools and work diligently to understand the local market.
- Keep the information flowing – Sign up for compliance updates and newsletters to stay informed.
Compliance checklist:
☐ Supplier – Can your supplier prove that they can manufacture your product(s) in compliance with applicable standards and regulations?
☐ Product standards – Do you know the applicable requirements needed to enter your product’s target market? Such as which regulations and conformity schemes apply to your product(s)?
☐ Substance regulations – Do you know which chemical and/or heavy metal restrictions apply in your target market?
☐ Document requirements – Which documents can be self-issued? Which documents must be issued by a third party? How long do you need to maintain the file?
☐ Labeling requirements – Do you know how your product must be labeled, marked and packaged for market entry?
Keeping up with regulatory changes can be challenging, but also necessary. Download our e-book to gain insight on global market complexities and solutions.