Have you heard of AI-powered medical devices? As technology advances, this term is becoming increasingly common. And, as a result, it is drawing the attention of regulatory authorities worldwide.
In this context, the FDA is advancing its regulatory framework for AI-powered medical devices. But beyond the U.S. market, there are also important updates related to sustainability requirements and post-market surveillance.
Below, we’ve gathered the latest regulatory highlights and explain why they deserve manufacturers’ attention.
FDA advances regulatory framework for AI-powered medical devices
The United States represents one of the largest medical device markets in the world. As such, we can expect regulatory developments to follow the pace of technological innovation.
In this regard, the Food and Drug Administration (FDA) has recently been working on its regulatory framework for artificial intelligence and machine learning technologies applied to healthcare.
The latest guidance addresses the entire product lifecycle, from development to post-market activities. The focus is on data governance, transparency, cybersecurity, and the use of real-world evidence.
One of the key highlights is the Predetermined Change Control Plan (PCCP), which allows manufacturers to plan and obtain prior authorization for certain future modifications to algorithms—without the need for a new submission for each update.
This model provides greater predictability for companies developing AI-powered medical devices, while reinforcing responsibilities related to safety and ongoing performance.
Sustainability becomes a key factor in access to public tenders in Brazil and Chile
In Brazil and Chile, environmental criteria are now playing a decisive role in public procurement processes in the healthcare sector.
Even if a product is properly registered with the health authority, it may be eliminated during the technical evaluation phase if it does not meet sustainability requirements.
In Brazil, Law No. 14,133/2021 allows for the assessment of environmental impact throughout the product lifecycle, including requirements such as life cycle assessment (LCA) and proof of reverse logistics.
In Chile, environmental criteria have been gradually incorporated into technical scoring, reinforcing the need for manufacturers to align regulatory and commercial strategies.
Tip: The Latin American market has been gaining traction as a destination for medical device manufacturers. At Sobel, our regulatory specialists focus on these markets—why not explore opportunities to access Mercosur countries?
Anvisa establishes Cosmetovigilance Technical Committee
Anvisa has announced the creation of a Cosmetovigilance Technical Committee. The goal is to strengthen the monitoring of cosmetic product safety after they are placed on the market.
This initiative aims to expand data analysis, support regulatory decision-making, and promote greater integration among different stakeholders in the sector.
This move reinforces the importance of robust post-market surveillance systems and signals a trend toward greater regulatory maturity in the cosmetics sector, aligned with international practices and RDC No. 894/2024.
China discusses new mandatory safety standard for cosmetics
Still on cosmetics, the Chinese health authority has opened a public consultation for the first mandatory national safety standard applicable to toothpaste.
The proposal establishes clearer technical requirements and strengthens regulatory control over cosmetic products marketed in the country.
For manufacturers operating internationally, the advancement of mandatory standards in China highlights the importance of closely monitoring local regulatory changes and quickly adapting technical documentation and compliance strategies for each target market.
Artificial intelligence, safety, and sustainability
Every week, a series of changes takes place across regulated markets worldwide.
From AI-powered medical devices to sustainability requirements and cosmetic safety, these developments can directly impact manufacturers.
Taken together, these updates show that market access no longer depends solely on formal regulatory approval.
They also highlight the importance of staying ahead and well informed. That’s where Sobel’s regulatory newsletter makes a difference.
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Remember: information is essential to reduce risks, avoid rework, and maintain competitiveness in an increasingly complex regulatory landscape.
