The healthcare and pharmaceutical industry is one of the most heavily regulated sectors in the world. For international companies looking to enter the Brazilian healthcare device market, ANVISA plays a crucial role in this puzzle, and it’s essential to master the stringent regulations it has established.

However, when these companies expand their operations to Brazil, the legalization of documents becomes a crucial part of the process.Let’s explore how to navigate this step to ensure a smooth entry and compliance with local rules.

🌎 Consularization: Consularization is an option when you need to authenticate ANVISA documents for countries not part of the Hague Apostille Convention. This involves a authentication process at a consulate or embassy of the destination country. It’s a necessary path for many companies operating in markets that do not adopt Apostille.

How It Works: To carry out Consularization, you must present the original document to the consulate or embassy of the destination country. The consular authority will verify the authenticity of the signature, seal, and content of the document. After verification, they issue a certification or authenticity seal, making the document legally valid in the foreign country.

🏛️ Apostille: On the other hand, if you’re dealing with countries that are signatories of the Hague Apostille Convention, Apostille is a simpler and more cost-effective option. It validates documents effectively and is widely accepted in many countries, saving time and resources.

How It Works: When a document is Apostilled, an authority designated by the signing country of the Convention issues a certificate called an “Apostille,” which is attached to the original document. This certificate attests to the authenticity of the signature, seal, and the issuing authority of the document. The document, now Apostilled, is considered valid in all Convention signatory countries.

Note: It’s important to emphasize that the choice between Consularization and Apostille depends on the destination country and its specific regulations. On the website of the National Council of Justice (Conselho Nacional de Justiça – CNJ) in Brazil, you can check which countries are signatories to the Hague Apostille Convention and the contact information of competent authorities in these countries, facilitating the Apostille process. Visit : https://www.cnj.jus.br/paises-signatarios/

📑 📑 ANVISA Regulatory Documents: Good Manufacturing Practice Certificates (CBPF), Operating Authorizations (AFE), Product Registration Certificates, and technical reports are vital documents for any company in the healthcare industry. However, when it comes to using them internationally, questions arise about how to make them valid in other countries.

🧪 Technical Reports: Often, companies in the healthcare and pharmaceutical industry need to prepare comprehensive technical reports to document tests, clinical trials, stability studies, and other scientific data. These reports are crucial for regulatory approvals and proving the efficacy and safety of products. When intended for foreign countries, these reports may require legalization, either through consularization or apostille.

🧪 Analysis Certificates: Analysis certificates are documents that attest to the quality of medical devices and other health-related products. They are frequently used in import operations and may eventually need to be legalized for international recognition.

🧪 Clinical Trial Registration Documents: When conducting clinical trials for medical devices, associated documents such as trial protocols, trial reports, and informed consents may need to be legalized for international use. This is especially important for companies seeking approval in multiple countries.

🧪 Free Sale Certificates: To register Class III and IV products, ANVISA requires manufacturers to submit the relevant Free Sale Certificates issued by the health authorities of the countries of origin, indicating that the products to be registered are

freely sold in those countries. The legalization of this certificate represents international recognition.

🧪 Authorization Letter: For imported medical devices, one of the required documents by ANVISA is a statement issued by the legal manufacturer, consularized or apostilled, written in Portuguese, English, or Spanish or accompanied by a sworn translation, issued no more than two years ago when there is no explicit validity indicated in the document, authorizing the requesting company to represent and commercialize their products in Brazil. This letter must be issued by the Legal Manufacturer and affirm compliance with the Good Manufacturing Practices for Health Products established in the Collegiate Board Resolution – RDC No. 665, dated March 30, 2022, or any regulation that may replace it.

✍️ Sworn Translation: Remember that, in addition to authentication, sworn translation may be necessary to ensure that documents are correctly understood in the language of the destination country. For your information, ANVISA accepts all documents written in Portuguese, English, and Spanish. Documents written in other languages must be submitted for sworn translation, as per RDC 36/2015 and 751/2022.

Handling the legalization of ANVISA documents is crucial to ensure compliance and successful international expansion. It’s a complex terrain, but understanding the available options can simplify the process.

When considering the internationalization of your healthcare products and services, consider not only ANVISA regulations but also the legalization and translation requirements for target markets. Regulatory compliance is essential to ensure patient safety and product performance.

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*Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br.