How can the Passarini Group ecosystem help your company?

At Passarini Group, we understand that regulation is only one part of the strategy. Our ecosystem offers an integrated solution (One Stop Shop) so that your company not only complies with the law but also gains efficiency.

We offer support from the technical interpretation of the IN approved in ROP 2/2026 to assistance in structuring files for API integration. Our mission is to transform the regulatory challenge into a competitive advantage for your business.

The future of traceability has arrived. Is your company ready for SIUD?

ANVISA has digitized; your regulatory management needs to keep up. Contact Passarini Group and ensure the efficiency of the new system works in favor of your business.

contato@passarini.com.br

Furthermore, the FDA has ceased using the old “Quality System Inspection Technique (QSIT)” and adopted a new inspection model aligned with QMSR, reflecting the agency’s commitment to modern oversight and quality assurance practices.

Passarini Group is prepared to support medical device companies in this regulatory transition, offering compliance analysis services, adaptation of quality management systems, and personalized technical-regulatory support to meet the new FDA requirements.

Contact us to learn more about our services and how we can facilitate your sales in Brazil. Reach out to us at contato@passarini.com.br

Company Registration and Prior Compliance: The Shortest Path to ANVISA

The first and most fundamental step to enable the sale of your product in the Brazilian market and gain access to ANVISA’s services is to ensure Company Registration and Prior Compliance.

The notification of Class I and II products, although faster (routinely processed within up to 30 days after protocol), requires the company to be legally apt to operate, demonstrating its compliance even before product submission.

Conclusion: Stop Losing Time and Money

The regulatory path for Class I and II products, although seemingly simple on the surface, is full of technical requirements that, if ignored, lead to significant losses and frustration. Attempting to save money on proper regulatory advice almost always results in higher costs, launch delays, and unnecessary business risks.

Stop losing time and money with fees and more fees, and truly seek a specialized company like Passarini Group.

Contact us so we can present our services and enable your sales in the Brazilian market, now: contato@passarini.com.br

Your Solution is Compliance 4.0: Passarini Group at the Forefront

The New ANVISA System is a gatekeeper of processes. To navigate this more rigorous environment, Passarini Group offers strategic solutions that transform these challenges into competitive advantages:

• Strategic Pre-Hearing Consulting: Avoid programmed refusal. Our team precisely maps the technical competence for your agenda, ensuring successful scheduling on the first attempt.
• Integrated Document Management Platform: Solve the 5-year retention challenge. Our RegTech securely stores and indexes recordings and minutes, ensuring full compliance with Ordinance 54/2021 and LGPD.
• Proactive Regulatory Alert Service: Eliminate the risk of inaction. Receive instant alerts about status changes (“Awaiting submission”), ensuring immediate responses and keeping your process always moving.

ANVISA has digitized; your regulatory management needs to keep up. Contact Passarini Group and ensure the efficiency of the new system works in favor of your business.

contato@passarini.com.br

The Authorization to Operate (AFE) and Special Authorization (AE) are foundational documents for any company seeking to operate in a market regulated by the Brazilian Health Regulatory Agency (ANVISA), covering sectors such as pharmaceuticals, medical devices, cosmetics, and sanitizing products. Historically, the waiting time for the issuance of these certificates — even after approval — has been a bottleneck directly impacting companies’ time-to-market.

In a move that marks a significant step forward in Digital Transformation and Bureaucracy Reduction, ANVISA has announced that the issuance of AFE and AE certificates will now be carried out automatically through the Solicita system. This change represents a true revolution in the relationship between the regulated sector and the Agency, eliminating manual intervention in the issuance process and ushering in a new era of agility.

The Impact of Automation on Your Business

Automatic issuance is more than a technological upgrade — it’s a strategic factor for improving predictability and operational efficiency.

Passarini Group: Your Partner in the ANVISA 4.0 Era

This ANVISA initiative reflects Brazil’s commitment to regulatory modernization. For companies looking to enter or strengthen their position in the Brazilian market, having a strategic partner who understands this new regulatory dynamic is essential.

Passarini Group is at the forefront of monitoring these transformations. Our team is fully prepared to ensure that your AFE and AE petitions (and all subsequent processes) are submitted with the precision required to take full advantage of automation efficiency.

Don’t waste time on bureaucracy — focus on scaling your business.

Contact our experts today and get your company ready for ANVISA’s new pace!

contato@passarini.com.br

The term “tarifaço” refers to the steep tariffs imposed by the United States on certain imported products — in this case, Brazilian medical devices — which increase the cost of direct access to the U.S. market. As a result, Brazilian companies have been seeking alternative markets to channel their products.

After the tariffs took effect, Brazilian exports of medical devices to the U.S. recorded a decline of approximately 30.04% on a monthly comparison basis. In August, sales to that destination totaled around USD 21.2 million, the lowest value of the year. In contrast, exports to Europe grew significantly between July and August, by 44.51%. Highlights include Spain (+632.59%), France (+238.77%), and Switzerland (+130.72%). In Latin America, countries such as Bolivia (+56.18%) and Mexico (+28.34%) also became more relevant destinations.

Segments with higher added value felt the impact of the tarifaço more strongly when it came to the U.S. market. For example, dentistry, rehabilitation, and medical equipment registered sharp declines in exports to the U.S. Another critical point is Brazil’s dependency on imported inputs, many of them sourced from the U.S. For the medical device sector, this creates risks, as costs and supply chains become more vulnerable to external tariff policies.

The growth of exports to alternative markets demonstrates existing demand, but maintaining this new flow requires Brazil to remain competitive — whether in terms of cost, regulation, quality, logistics, or predictability. The sales crisis in the U.S. market is forcing exporters to explore different destinations — Europe and Latin America, for instance. The more diversified the export markets, the lower the risk of being impacted by the policies of a single country. A key factor mentioned is the need for international agreements and regulatory reciprocity. In other words, if regulatory standards between Brazil and its partners are more closely aligned, trade and bureaucratic barriers can be reduced, facilitating exports.

The most complex, higher value-added medical devices are disproportionately affected by higher tariffs, as their costs already involve specialized raw materials, advanced technology, and strict regulatory compliance. Dependency on external components and inputs — particularly from the U.S. — creates vulnerability: exchange rate fluctuations, logistics costs, and external tariff and regulatory barriers can all impact the final cost and competitiveness of Brazilian products.

📺 Watch the full CNN report here:

The U.S. tarifaço created an immediate shock for the Brazilian medical device sector, especially in higher value-added categories. However, this shock also acted as a catalyst for exporters to seek alternatives: more markets in Europe, Latin America, and potentially beyond. To ensure that this change of route is not merely temporary or superficial, Brazil will need to improve its competitiveness conditions — through public policies, infrastructure, tax incentives, international regulatory harmonization, and diversification of export destinations.

In this context, Passarini Group acts as a strategic partner for Brazilian companies, providing comprehensive support to expand business operations and ensure regulatory compliance in new markets. With international expertise, Passarini Group facilitates the entry of medical devices into alternative destinations, helping transform challenges into opportunities for global growth. Click the button below and get in touch with us.

Contact our experts and find out how we can accelerate your sanitary registration in Mexico. Send an email to contato@passarini.com.br

ANVISA has recently published the new Import Manual, confirming that the Declaration of the Registration Holder (DDR) will remain valid. This document allows the holder of a product registered in Brazil to authorize third parties to carry out direct imports, ensuring greater agility, flexibility, and legal certainty in operations.

In recent months, the industry had been concerned about potential regulatory changes, especially with the implementation of the Single Import Declaration (DUIMP) and new customs requirements. Many importers feared that the DDR would be discontinued or become more bureaucratic, leading to delays and increased costs. ANVISA’s confirmation has brought predictability and reassurance to companies and distributors, ensuring that this well-established model continues to function.

Although the DDR remains valid, companies must pay attention to certain adjustments. It is important to understand how it integrates with new electronic systems, such as DUIMP and LPCO, and to verify possible additional documentation requirements. Furthermore, alignment between registration holders, importers, and distributors remains essential to ensure efficient and compliant operations.

The maintenance of the DDR reinforces the stability of the regulated market, allowing already registered products to be imported in a practical and legal manner. For the sector, this means security, operational continuity, and greater predictability in imports, even in light of the changes introduced by the new Import Manual.

At Passarini Group, we closely monitor all updates in the regulatory market and ANVISA’s decisions, ensuring our clients have access to accurate, up-to-date information and specialized support to operate safely and efficiently in the regulated import sector.

To better understand all the changes and check details about the procedure, watch the explanatory video here.

To download the complete import manual (in Portuguese), click here.

Contact our experts and find out how we can accelerate your sanitary registration. Send an email to contato@passarini.com.br

The regulatory landscape for the entry of medical devices into Mexico has just undergone a significant transformation. On July 18, 2025, the “Acuerdo por el que se emiten los Lineamientos generales para la aplicación de la vía regulatoria abreviada para el otorgamiento de los registros sanitarios de insumos para la salud” (Agreement issuing the general guidelines for the application of the abridged regulatory pathway for granting sanitary registrations for health supplies) was published in the Official Gazette of the Federation. This document establishes a new abridged regulatory pathway for obtaining sanitary registrations, representing a crucial step forward for companies seeking agility and efficiency in the authorization process.

The main objective of this new regulation is to allow the Federal Commission for the Protection against Health Risks (COFEPRIS) to recognize evaluations, tests, and requirements already approved by other reference regulatory authorities (RRAs) and by the World Health Organization (WHO) prequalification program.

This mechanism is based on the principle of “Reliance,” a global concept of Good Regulatory Practices recommended by the WHO. Reliance is the act of a regulatory authority considering and giving weight to evaluations conducted by another trusted authority to make its own decisions. By means of these new guidelines, COFEPRIS optimizes its resources and increases efficiency, avoiding the duplication of evaluation processes that have already been carried out by renowned agencies abroad.

The abridged pathway does not compromise the safety, quality, or efficacy of the products. COFEPRIS ensures that the health supply is identical to the one approved by the RRA, with the same essential quality characteristics and components. The RRA approval must have been issued no more than five years ago.

What changes for companies?

The new procedure applies to a wide range of products, including medicines such as generics, new molecules, innovative biotechnological products, biosimilars, biological products, and vaccines. Medical devices are also included.

The document also specifies which are the Reference Regulatory Authorities (RRAs) recognized by COFEPRIS. For medicines, these include the founding members or permanent regulators of the ICH (International Council for Harmonisation), such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). For medical devices, COFEPRIS recognizes the decisions of the member countries of the International Medical Device Regulators Forum (IMDRF) Management Committee and the Medical Device Single Audit Program (MDSAP).

One of the biggest advantages is the resolution timeframe. With the new guidelines, COFEPRIS will have a maximum of 45 business days to issue a sanitary registration resolution for medicines and 30 business days for medical devices. This represents a huge reduction in waiting time, which can be a crucial competitive differentiator.

Navigating the complex regulatory environment in Mexico requires knowledge and experience. With a deep understanding of the new regulations and COFEPRIS’s requirements, Passarini Group can help your company take advantage of this opportunity.

Our team is ready to guide you through every step of the process, from preparing the necessary documentation to submitting and following up on your sanitary registration application. Avoid delays and ensure your entry into the Mexican market is a success by following the new abridged regulatory pathway.

Contact our experts and find out how we can accelerate your sanitary registration in Mexico. Send an email to contato@passarini.com.br

The Brazilian Health Regulatory Agency (ANVISA) has published a crucial update that directly impacts the industry and regulated sector, bringing more clarity and legal certainty to certification processes. From now on, the way the validity period for Good Manufacturing Practice Certificates (CBPF) and Good Distribution and/or Storage Practice Certificates (CBPD) is counted has been changed, with a specific rule for renewals.

The new rules work as follows:

Here is a practical example:

If a certificate expires on December 31, 2025, and the renewal is published on October 31, 2025, the new 2-year validity period will only begin on January 1, 2026, and not on October 31, 2025, as was the previous rule.

This change demonstrates ANVISA’s effort to align its processes with the needs of the sector, eliminating possible discrepancies and ensuring the full validity of certificates. Passarini Group emphasizes the importance of closely monitoring ANVISA’s regulatory updates. Remaining in compliance is essential for the success and safety of operations in the sector. Our team is available to help your company understand and adapt to this and other regulations.

ANVISA’s changes require attention and careful planning. Don’t let the complexity of the new rules compromise the validity of your certificates.

Count on Passarini Group to ensure your company is always in compliance. Contact us and discover how we can simplify your regulatory routine. Send an email to contato@passarini.com.br

Keeping up with constant regulatory updates is essential for any company in the sector. The Passarini Group highlights the recent publication of ANVISA’s Collegiate Board Resolution (RDC) No. 982, from July 28, 2025, which arrives to enhance risk management and compliance monitoring processes.

This new resolution does not represent a radical change, but rather an evolution. It optimizes how ANVISA will use health risk management and compliance monitoring criteria for the initial granting or renewal of Good Practice Certificates.

What Does RDC 982/2025 Mean for Your Company?

In essence, the new RDC establishes a more modern and efficient framework for company evaluations. Instead of being a one-time process, risk management and monitoring become more integrated and continuous criteria in the agency’s decisions. This means that ANVISA will have a more complete and proactive view of each company’s compliance.

For you, this translates into the need to maintain a robust and up-to-date management system that demonstrates a constant commitment to quality and safety.

Key Points for Your Attention

The Passarini Group is attentive to all updates and ready to help your company navigate these changes. Understanding and adapting to these enhancements is crucial to ensuring compliance and success in your regulatory processes.

For a complete understanding of the resolution and its implications, the Passarini Group encourages reading the full document. Access Collegiate Board Resolution (RDC) No. 982/2025 directly to delve deeper into the risk management and monitoring criteria.

Need Help Adapting to ANVISA’s New Rules?

Understand how RDC 982/2025 can impact your company and ensure a smoother and more secure certification and renewal process.

Contact our team of experts and guarantee your business’s compliance. Send an email to contato@passarini.com.br