Innovation, post-market surveillance, and evolving compliance expectations are reshaping the regulatory landscape worldwide. And, as regulatory authorities adapt to new technologies and market demands, manufacturers must stay alert to changes that can directly impact market access strategies.
In this context, Anvisa has taken an important step forward with its new Regulatory Sandbox initiative focused on personalized cosmetics. But beyond Brazil, there are also relevant updates involving post-market surveillance in China, discussions around MDR and IVDR requirements in Europe, and changes to ISO 10993-7.
Below, we’ve gathered the latest regulatory highlights and explain why they deserve manufacturers’ attention.
Anvisa advances Regulatory Sandbox for personalized cosmetics
Anvisa has announced the results of the preliminary selection stage for its Regulatory Sandbox focused on personalized personal care products, cosmetics, and fragrances.
Four innovative projects were considered eligible to move forward to the next phase, which includes a detailed technical evaluation of the proposals submitted by participating companies.
The initiative is part of Anvisa’s Experimental Regulatory Environment. It was designed to allow companies to test innovative business models under supervised regulatory conditions.
The new Regulatory Sandbox may allow companies to develop and test personalized cosmetic solutions at the point of sale. These activities may operate under temporary regulatory flexibilities and tailored protocols.
This movement reflects a growing trend in the cosmetics sector: increasing demand for personalization, digitalization, and customized consumer experiences.
China strengthens post-market surveillance requirements
China has issued new guidelines reinforcing post-market surveillance requirements for medical devices.
The updated rules place greater emphasis on risk assessment activities and stricter reviews of periodic reports, raising compliance expectations for both local and foreign manufacturers.
This means companies operating in the Chinese market may need more robust post-market surveillance systems, stronger documentation practices, and closer monitoring of local regulatory obligations.
Post-market activities are becoming increasingly strategic for maintaining compliance and long-term market access.
Notified Bodies raise concerns over MDR and IVDR revision
Team-NB has expressed concerns regarding proposed revisions to the MDR and IVDR frameworks in Europe.
According to the association, reducing post-market surveillance requirements could create regulatory risks and potentially impact patient safety over time.
The discussion highlights how post-market surveillance remains one of the central pillars of the European regulatory system, especially under MDR and IVDR.
For manufacturers, this serves as an important reminder that the European regulatory landscape continues to evolve. It also requires constant monitoring of legislative and regulatory discussions.
ISO 10993-7:2026 introduces updates to biological evaluation
International Organization for Standardization has officially updated ISO 10993-7:2026 with revised criteria related to sterilization residues.
The updated standard introduces a stronger risk-based approach, taking into account factors such as patient population and duration of use when defining acceptable limits.
Additionally, the new version provides expanded guidance for product release and assessment methodologies.
This update reinforces the growing expectation for manufacturers to provide more robust scientific justifications throughout biological evaluation activities and risk management processes.
Tip: Biological evaluation often raises questions among manufacturers, especially when compared to clinical and toxicological evaluations. In our latest blog post, we explain the differences between these assessments, how they relate to each other, and why they are essential throughout the regulatory process.
Innovation, post-market surveillance, and regulatory adaptation
Every week, regulatory authorities around the world introduce updates that can directly impact manufacturers in the medical device, IVD, and cosmetics sectors.
From the advancement of the Regulatory Sandbox in Brazil to stricter post-market surveillance requirements and evolving international standards, these changes reinforce how regulatory strategies must continuously adapt to innovation and global compliance expectations.
More than ever, staying informed is essential to reduce risks, avoid delays, and maintain competitiveness in increasingly complex regulated markets.
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