ORBIS Compliance: Your Trusted Partner for Global Insights in Telecom, Safety, Energy Efficiency, and Healthcare
Happy Thanksgiving, Compliance Industry!
As the fall season is coming to a close, it is a time of transformation, the ORBIS Team is excited to share the latest Regulatory Updates and key news shaping the compliance landscape. Get ready for an insightful experience, packed with the newest developments, strategic guidance, and innovative trends that will help refine your compliance strategies as the season changes. From the intricacies of telecommunications to evolving safety standards, medical, energy efficiency, and more—we’re here to equip you with the tools and expertise for success.
As we reflect on the season of gratitude, let’s embrace the renewed energy and focus that comes with it. Together, we can tackle the upcoming compliance challenges and look forward to a season of growth, empowerment, and outstanding achievements in compliance.
Wishing you all a joyful and fulfilling holiday!
Telecommunications
Japan: Innovation in the Automotive Sector - Technical Advances for Pressure Monitors and Remote Key Access
Big news for car tech enthusiasts and the automotive industry! Japan is making an important shift in wireless technology that could have a major impact on road safety and vehicle convenience. The country’s Ministry of Internal Affairs and Communications has just released a report from the Information and Communications Council, laying out the technical steps needed to advance low-power wireless systems for tire pressure monitoring (TPMS) and remote keyless entry (RKE) systems. And here’s the catch: starting November 12th, these systems will be moving to the 433 MHz frequency band, which is quickly becoming the global standard.
Right now, TPMS and RKE systems in Japan use the 315 MHz band, which is a low-power, unlicensed frequency. But as the 433 MHz band gains global traction, Japan is jumping on board to align its tech with international trends. This isn’t just about keeping up with the rest of the world—it’s about making sure these systems work seamlessly across markets and modernizing the country’s wireless infrastructure for maximum efficiency.
What does this mean for you? First off, it’s great news for road safety. More reliable tire pressure monitoring and smoother remote vehicle access will help reduce accidents and make driving more efficient. Plus, this change supports the broader growth of low-power wireless tech, paving the way for even more innovation in the automotive industry and beyond.
This move will affect a wide range of stakeholders—automakers, parts suppliers, consumers, and even regulators. As more countries adopt the 433 MHz band, the global wireless network will become even more connected, benefiting industries and consumers alike.
In short, Japan’s shift to the 433 MHz band starting November 12th not only aligns the country with global standards but also strengthens its position as a leader in automotive tech and safety. It’s a big step forward that will bring smoother, safer, and more efficient experiences for consumers everywhere.
Published November 12th
Australia: Radio Frequency Spectrum Plan Updates
Big changes are coming to Australia’s Radio Frequency Spectrum Plan, with updates set to take effect on December 16th. Why should you care? These updates, based on decisions from the 2023 World Radiocommunication Conference (WRC-23) in Dubai, will bring new frequency allocations for mobile telecommunications (IMT) and revise rules for maritime, aviation, and satellite services. But what does this mean for you?
The goal of these updates is to make better use of the spectrum and keep Australia in line with international standards set by the International Telecommunication Union (ITU). So, how will this affect your daily life? If you rely on mobile services, the changes are designed to help meet growing demand for wireless communication, meaning faster and more efficient service.
But the impact isn’t limited to just telecoms. These updates will also affect industries like defense, research, and emergency services. Whether you’re involved in space research or maritime communication, the changes will ensure your sector has the spectrum it needs to function smoothly. Are you ready for those adjustments?
The new rules will affect a wide range of stakeholders, including telecom providers, government agencies, and consumers. So, what do you need to do? If you’re in one of these sectors, it’s time to start preparing for these changes and understanding how they’ll affect your operations.
In short, these updates to Australia’s Radio Frequency Spectrum Plan will not only keep the country in sync with global standards but also boost technological growth and improve spectrum management across industries. Are you ready for the new era of wireless communication? Make sure you’re prepared before December 16th!
Published November 8th
Mexico: Chamber of Deputies Approves Proposal to Dissolve IFT Telecommunications Regulator and CRE Energy Regulatory Body
The Mexican Chamber of Deputies recently approved a proposal to dissolve the Federal Telecommunications Institute (IFT) and other key regulatory bodies as part of a larger effort to streamline the country’s administrative structure. This move is part of a set of reforms that also include changes to the Constitution—specifically to the article that guarantees citizens’ rights to access information, communication technologies, and broadcasting services.
So, what’s actually changing? Under the new plan, the regulatory responsibilities currently handled by the IFT would be taken over by the Federal Executive Powers. This means more centralized control over areas like telecommunications, broadcasting, and energy regulation—this includes bodies like the Energy Regulatory Commission (CRE) and the National Institute of Transparency (INAI).
The idea behind these reforms is to simplify governance and foster competition in these sectors. However, there are concerns about what this could mean for the independence of regulatory bodies. With more power concentrated in the hands of the Federal Executive, some worry that it could impact decision-making, potentially lead to uneven regulation, and alter the dynamics of the market. Changes to the radio spectrum bidding process and the creation of a new National Infrastructure Information System could also affect companies in the sector and the market as a whole.
Who’s affected?
In short, these reforms could dramatically reshape Mexico’s telecommunications and broadcasting industries. By consolidating regulatory power in the hands of the federal government and changing key processes like bidding for radio spectrum, the reforms could have a lasting impact on both industry players and consumers. The big question is whether this shift will improve efficiency or risk undermining the independence that these bodies once had.
Published November 7th
Saudi Arabia: Exciting News for Wireless Technology with New 6 GHz Licensing Rules
Great news for the future of wireless technology! The Telecommunications Services Committee (CST) is rolling out a new regulation aimed at making better use of the 6 GHz frequency band. This change, effective November 20th, introduces a light licensing approach designed to optimize spectrum use for Wireless Local Area Networks (WLANs), offering more flexibility while ensuring interference-free operation.
What’s changing? The 6 GHz band is now open for both indoor and outdoor WLAN applications. For indoor use, low-power devices will be able to operate without restrictions, while outdoor devices can run at higher power levels, but only under a new Automatic Frequency Coordination (AFC) system. This system will help make sure that new devices can coexist with existing services without causing interference.
To keep everything running smoothly, devices using the 6 GHz band will need to meet certain requirements, such as power limits, emission standards, and the ability to pinpoint their location. Before operating, devices must also register with the AFC system and stay in daily communication to receive updates on available channels and power limits.
Why does this matter? The regulation paves the way for better access to crucial spectrum, which is essential for the growth of next-gen wireless technologies. It creates a more flexible regulatory environment that fosters innovation and competition in the telecommunications space, while ensuring quality of service is maintained.
In short, this new framework will help unleash the potential of the 6 GHz band, supporting the development of advanced WLAN technology and benefiting telecom operators, equipment makers, and end users alike. Get ready for some exciting changes starting November 20th!
Published October 23rd
Safety
Canada: AI Revolution Launches Artificial Intelligence Security Institute
Canada is taking a big step toward responsible AI development with the launch of the Canadian Artificial Intelligence Security Institute (CAISI) in Montreal. Announced by Minister Fran?ois-Philippe Champagne, CAISI will focus on managing the risks associated with AI, such as disinformation, cybersecurity threats, and election interference, while ensuring the safe and ethical use of these technologies.
This initiative is part of a broader $2.4 billion investment outlined in Canada’s 2024 federal budget, aimed at advancing AI innovation responsibly. Drawing on Canada’s strong AI research ecosystem and top-tier talent, CAISI will help the country remain at the forefront of global AI leadership.
In addition to working with international partners through the new International Network of AI Safety Institutes, CAISI aligns with Canada’s support for the Bletchley Declaration—an international pledge for AI safety. The institute’s efforts will also complement key Canadian regulations, like the Artificial Intelligence and Data Act, which aim to balance innovation with public trust.
With an initial $50 million budget, CAISI will support Canadian researchers, startups, and businesses working in AI, driving both innovation and economic growth. By addressing AI risks and increasing public confidence in these technologies, CAISI will play a crucial role in ensuring AI’s responsible and ethical use.
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In short, CAISI is set to position Canada as a global leader in AI safety, shaping a future where AI benefits society in a secure and responsible way.
Published November 12th
Argentina: Alert to the new Provision 1/2024 Innovation in the Conformity Assessment Framework
Argentina’s product certification process is getting a significant update with Provision 1/2024 under Resolution No. 237, which introduces new guidelines for product conformity assessment aimed at enhancing safety. These changes give manufacturers and importers more flexibility while ensuring stronger safety standards for consumers.
One of the key updates is that businesses now have the option to retain their existing security seals or switch to the new “CONFORMITY MARK,” which includes a QR code linking to product safety and compliance documentation. This allows businesses to transition smoothly while meeting the updated requirements until the deadline set in Article 4 of the provision.
The update also clarifies important terms like “certification” and “conformity,” emphasizing that accreditation must align with the technical standards required for product safety. To ensure ongoing transparency, the Argentine Accreditation Body (OAA) will provide monthly updates on accreditations to the National Directorate of Technical Regulations (DNRT).
These changes impact industries ranging from electronics to toys and industrial equipment, and they stress the importance of safety and compliance. Manufacturers and importers must meet the new requirements to avoid penalties and ensure their products are safe for consumers. The Conformity Mark, along with the QR code, will improve product transparency, allowing consumers easy access to critical safety information.
Additionally, the introduction of the Remote Procedures Platform (TAD) will simplify the certification process, reducing response times and making it easier for businesses to meet compliance requirements.
Overall, these updates aim to create a safer, more transparent market in Argentina, protecting consumers while promoting trust in the marketplace. Businesses should start preparing now to comply with the new safety-focused regulations.
Published November 7th
European Union: Cyber Resilience Act Strengthening Cybersecurity for Digital Products
Exciting updates are coming for digital products in the European Union! On October 23, 2024, the European Parliament and Council officially introduced the Cyber Resilience Act, a new regulation designed to strengthen the cybersecurity of products with digital elements. This law targets products connected to devices or networks, ensuring they meet essential cybersecurity standards to protect both users and organizations across the EU.
The new regulation applies to most digital products on the market, though there are some exceptions, such as medical devices and defense equipment, which fall under other specific EU regulations. For manufacturers, this means assessing cybersecurity risks, maintaining technical documentation, and managing vulnerabilities. They’ll need to identify potential cybersecurity risks, keep detailed records for compliance, and ensure their products are free from known vulnerabilities. Manufacturers will also be required to provide timely security updates and report any actively exploited vulnerabilities or significant cybersecurity incidents to authorities like the Computer Security Incident Response Teams (CSIRTs) and the European Union Agency for Cybersecurity (ENISA).
The Act also outlines responsibilities for authorized representatives, importers, and distributors, who will need to collaborate with market surveillance authorities and ensure products meet cybersecurity standards. The regulation took effect 20 days after publication in the Official Journal of the EU, with full enforcement set for October 23, 2027. However, some obligations, such as vulnerability notifications, will kick in 21 months after publication, while conformity assessment body requirements will begin 18 months post-publication.
To demonstrate compliance, products will need to carry a CE marking, indicating that they meet the required cybersecurity standards. The CE marking must be visible, legible, and indelible, and if it’s not practical to affix it directly to the product, it can appear on packaging or the EU declaration of conformity. The marking can be as small as 5 mm in height, as long as it remains visible, and must be placed on the product before it enters the market. If a notified body is involved, their identification number must also be included.
Overall, the Cyber Resilience Act is designed to fortify the cybersecurity framework for digital products, helping to protect consumers and businesses throughout the EU. While full enforcement is still a few years away, businesses should start preparing now to meet the upcoming compliance deadlines. Stay tuned for more updates as the timeline unfolds!
Published October 23rd
Energy Efficiency
Brazil: ANATEL Enhances Electronic Processes for Greater Efficiency
Great news for anyone navigating electronic processes with the National Telecommunications Agency (ANATEL)! The agency has officially approved updates to its Electronic Process Regulations, first set out in Resolution No. 682 in August 2017. These changes, which will take effect on December 2nd, are all about making things quicker, safer, and more efficient for everyone involved.
The revised regulations bring several important updates designed to speed up administrative procedures and boost security. By simplifying operations for all parties, the goal is to reduce delays and make processes smoother for users while improving the Agency’s workflow.
One of the major changes is the increased agility of the system. By removing temporary measures and shortening citation deadlines, ANATEL can process cases much faster, allowing for quicker resolutions. This means users will see faster response times and better service overall.
Security and transparency also get a major upgrade. The new regulations require stronger control of representation within the Electronic Information System (SEI), ensuring that all processes are more secure and transparent. This change helps foster greater trust, both for users and for the Agency.
Overall, the updates will lead to smoother, faster interactions with ANATEL, improving the experience for users while helping the Agency manage a higher volume of cases more effectively. With these changes, ANATEL is setting a new standard for efficiency and security in its electronic processes. If you’ve been waiting for faster, more reliable service, this is the update you’ve been hoping for! Keep an eye out for these changes starting December 2nd.
Published November 4th
European Union: New Emission Limits for Wireless Power Transmission Devices
Have you heard about the new draft recommendation for low-power, beamless Wireless Power Transmission (WPT) devices? These devices use electromagnetic fields to transmit power from a transmitter to a receiver, and the power can either be stored in a battery or used to directly power a device. Sounds pretty futuristic, right? But what does this mean for the industry and for you?
The new recommendation lays out updated emission limits for these devices, with a clear focus on preventing harmful interference in the radio frequency spectrum. After all, the last thing we want is for WPT devices to disrupt other communication systems. These limits are designed to ensure that low-power WPT devices—like inductive coupling and magnetic resonance—play nicely with existing radio services.
Why is this important? The recommendation, developed by CEPT, ETSI, and CENELEC, seeks to harmonize emission standards across CEPT countries. By aligning with established ETSI standards, it simplifies regulatory compliance. This means manufacturers can more easily develop and market WPT devices, especially in Europe. But what about other parts of the world? Will this affect you if you’re outside the CEPT region?
The focus is on low-power, beamless WPT technologies like inductive coupling and magnetic resonance, so the regulations will mostly impact manufacturers and users of these specific devices. If you’re using or producing other types of wireless power transmission technologies, the changes may not affect you much. But if you are in the WPT space, how will these new emission limits change your business or product?
While the update doesn’t represent a major shake-up in the industry, it’s still a key step in ensuring that WPT technologies integrate smoothly with other communication services. For manufacturers and users in the CEPT region, these harmonized standards will make product development and compliance much easier. But for everyone else, the impact may be less significant.
So, if you’re a manufacturer of low-power, beamless WPT devices or a regulator in the CEPT region, these updates will be something to pay attention to. For the rest of us, we may see improved product compatibility and reduced interference in the long run. But either way, it’s an exciting step forward in the world of wireless power! Are you ready for the future of power transmission?
Published October 21st
Medical
Brazil: Law No. 15,022 A Decisive Step in Chemical Substances Management and Environmental Protection
Big news for businesses and industries in Brazil! A new law has just been published in the Diário Oficial da Uni?o (DOU), marking a major step forward in regulating chemical substances in the country. Law No. 15,022 establishes the National Inventory of Chemical Substances and sets out clear regulations for assessing and managing the risks of chemicals used, produced, or imported in Brazil.
The law takes effect immediately, with the goal of enhancing oversight and control to protect both public health and the environment. It applies to all chemicals used, produced, or imported into Brazil, impacting a wide range of industries, from manufacturing to agriculture. However, it does not cover radioactive materials, chemicals still in development, research-only substances, waste products, or those related to national defense.
While the law is already in effect, public authorities have 180 days to issue the necessary regulations, and the full implementation of information systems for monitoring and enforcement must be completed within three years. This means businesses will need to act quickly to comply with the new requirements.
For manufacturers and importers, Law No. 15,022 introduces strict obligations, including registering chemicals in the National Inventory and following detailed risk management practices. Non-compliance can result in severe penalties, underscoring the importance of meeting these new standards.
This legislation is a transformative step in Brazil’s approach to chemical substance management. With a strong focus on public health, environmental protection, and long-term sustainability, it will have wide-reaching effects on businesses, government authorities, and the general public. Companies will need to prepare for these changes and ensure they are fully compliant as the regulations take shape over the coming months. Stay tuned for more updates as the law moves toward full implementation.
Published November 14th