Updates in Medical Device Regulation!   Today, on December 11, 2023, RDC 830/2023 was published in the Official Gazette, introducing significant changes. It will revoke RDC 36/2015 and modify Normative Instruction No. 3, dated August 26, 2015, as soon as it comes into effect.  Essentially, this new RDC consolidates and updates aspects related to risk classification, notification and registration regimes, along with labeling requirements and usage instructions for in vitro diagnostic medical devices and their instruments. Important note: It will only come into effect starting from June 1, 2024.  🔍 Check out the English translation firsthand in the attachment!  RDC  830-23 – EN  ⏳ Stay tuned! Tomorrow, our team of experts will present a detailed analysis of this new regulation. Send an email to contactBR@brisa.com.br to receive the Gap analysis firsthand!  📌 Comment below if you have any considerations about this announcement!  #RegulatoryAffairs #BrisaAdvisors #BPOinRA #MedicalDevices #MedicalDeviceRegulation #RDC830 #PublicHealth #MedicalInnovation #InVitroDiagnostics #HealthRegulations #HealthUpdates #MedicalTechnology  Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

“In 2023, the medical devices industry faces significant environmental challenges. The environmental impact of the healthcare sector as a whole is a pressing concern. This industry faces stringent regulations, making the transition to more sustainable practices a challenge. The waste generated by hospitals and healthcare facilities is a major issue due to the use of disposable devices like masks and gloves, and high energy consumption.  Researchers emphasize the importance of adopting renewable energies as an environmentally positive solution. The transition to more sustainable energy sources in hospitals can have a significant impact. Additionally, telemedicine and digital health reduce the environmental footprint by allowing healthcare professionals to efficiently attend to patients, avoiding unnecessary travel.  When it comes to innovation in environmental technology, companies like Philips and Siemens Healthineers stand out. Philips is committed to reducing its CO2 emissions and maximizing the lifespan of its devices. Siemens Healthineers is also dedicated to emissions reduction and adopting sustainable practices.  In the social and governance aspect, the medical devices sector must address challenges related to corruption, transparency, data security, employee safety, and work standards. As digitization progresses, data security becomes especially critical due to the vulnerability of medical information.  Many companies in the sector are believed to be committed to improving their ESG performance, although stringent regulations demand a cautious approach. However, several companies have already set ambitious goals to achieve, demonstrating their continued commitment to sustainability.  This is an exciting time for the medical devices industry as it strives to balance innovation and social and environmental responsibility. Together, we can work towards making this industry more sustainable and ethical.  “Let’s continue the conversation and seek solutions that benefit everyone. If you have any ideas or comments on the subject, please share with us in the comments.”  #RegulatoryAffairs #BrisaAdvisors #BPOinRA #MedicalDevices #ESG #Sustainability #Innovation #SocialResponsibility #DigitalTransformation”  Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

🤝🔬 The collaboration between Anvisa (National Health Surveillance Agency) and ANMAT (National Administration of Drugs, Foods, and Medical Technology) is streamlining access to medical devices between Brazil and Argentina! 🌎✨  Recently, the regulatory agencies signed an agreement to facilitate the approval and trade of low-risk medical devices. This agreement allows for the mutual recognition of certificates of free sale and certificates for foreign countries for medical devices classified as Classes I and II, as well as In Vitro Diagnostic medical devices A and B, between Anvisa and ANMAT, based on Law No. 9782/1999. Medical devices that will benefit from this bilateral agreement must meet the following regulatory requirements:   • Low-risk medical devices that do not pose significant health or life risks to individuals.   • Medical devices classified according to the classification rules established by Anvisa and ANMAT.   • Medical devices must be regulated with Anvisa or ANMAT, as appropriate, through notification or registration procedures, depending on the risk class.  •Medical devices must comply with labeling and instructions for use defined by Anvisa and ANMAT, following international standards.   •Medical devices must have a certificate of free sale and a certificate for a foreign country issued by the health authority of the country of origin, which will be mutually recognized by Anvisa and ANMAT, without the need for apostille and translation into Spanish, reducing time and cost.  •Medical devices must comply with good manufacturing practices, control and distribution standards, as well as post-market surveillance standards, as per the legislation of each country.  This partnership aims to optimize resources, processes, and regulatory outcomes, avoiding rework and fostering mutual trust. The mutual recognition of decisions and documents issued by national authorities seeks to simplify bilateral trade and regulatory cooperation. Together, we are building a more agile and efficient path for the regulation of medical devices, benefiting the health and well-being of our communities.  If you have any questions, please share them in the comments below; our team is available to assist! To access the official announcement, click here.   #RegulatoryAffairs #BrisaAdvisors #BPOinRA #MedicalDevices #PublicHealth #InternationalCollaboration #Anvisa #ANMAT #InnovationInHealth  Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

In March 2023, China took a significant step on the international stage by joining the Hague Convention. A decision that will have wide-ranging implications in the legal world and international business. 🌐  Link to the Official Announcement – GOV   Starting today (November 7, 2023), the legal effects of this accession will come into force, bringing with it a fundamental change in the authentication process for documents destined for China. 📜✍️  Here are the key changes you need to know:  1️⃣ Apostille, Not Legalization: From November onwards, documents originating from and/or destined for China will no longer require legalization but will instead need to be apostilled. This will significantly simplify the authentication process, making it faster and more accessible.  2️⃣ Brazilian Apostille: Apostilling Brazilian documents destined for China can be done at any authorized notary office. To check the list of authorized notary offices for apostilling documents in Brazil, click here  . This is great news for businesses and individuals dealing with international documents.  3️⃣ Chinese Documents for Brazil: For Chinese documents intended to have legal effect in Brazil, apostilling must be carried out with the competent authority in the People’s Republic of China (Signatarios Countries ).  The aim of this change is to replace and simplify the act of document legalization, making international business more agile and straightforward. This is excellent news for anyone operating in the global market. 🌐  We are here to answer your questions and assist you in adapting to these important international environment changes. Be prepared to make the most of this new era of streamlined international processes and business. 👍🤝  If you still have questions about the difference between apostille and consularization, don’t miss reading our newsletter (International Document Legalization: Consularization or Apostille?) and leave your comments.  #RegulatoryAffairs #BrisaAdvisors #BPOinRA #MedicalDevices #HagueConvention #China #InternationalBusiness #Apostille  Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

In the age of technology and medicine, MEDICA stands out as a platform where the brightest minds come together to explore the present and future of healthcare.  Why is MEDICA so vital?  🌍 Global Perspective: The event brings together experts and healthcare professionals from around the world, offering a global perspective on best practices and innovations in medicine.  🔬 Innovation: Advances in medical technology, innovative devices, and cutting-edge healthcare solutions are showcased in the exhibitions. This is where the most revolutionary ideas come to life.  🤝 Powerful Networking: MEDICA creates an environment conducive to establishing valuable connections with colleagues, forming strategic partnerships, and collaborating on projects that can change the way healthcare is delivered.  📚 Continuous Learning: The standout educational programming covers topics shaping modern medicine. The knowledge gained here can inspire innovations and significant advancements.  🗓️ Save the Dates: MEDICA will take place from November 13 to 16 in Düsseldorf, Germany. Mark it on your calendar and be prepared for an experience that can change your professional path, for more innovative and effective healthcare.  The presence of leaders in the medical field provides a unique opportunity to share ideas and visions. If you’re there too, we’d love to meet up to exchange ideas and visions.  Together, we are paving the way for a bright future in healthcare. 🌟  Find out more about BPO in RA!   #RegulatoryAffairs #BrisaAdvisors #BPOinRA #MedicalDevices #MEDICA #WorldMedicalForum #MedicalInnovation #HealthandTechnology #GlobalMedicine #HealthandTechnology #MedicalNetworking #Düsseldorf #Germany   *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

Dear LinkedIn connections,  It’s time to start planning ahead for the next year! 2024 promises to be an exciting year for the medical technology industry, with significant innovations in fields like diabetes, cardiology, orthopedics, and more. The top medical technology conferences in 2024 will play a crucial role in unveiling the latest trends, discoveries, and challenges that will shape the future of the industry.As the industry prepares to confront new disruptive technologies, evolving regulations, and ever-changing global economic issues, these events are vital for keeping leaders informed and inspired. From regulatory complexities to groundbreaking discoveries, there will be much to discuss and learn.  Here is a list of the top medical technology conferences you won’t want to miss in 2024:  📅 J.P. Morgan Healthcare     – Date: January 8-11     – Location: San Francisco, California  📅 Consumer Electronics Show (CES 2024)     – Date: January 9-12     – Location: Las Vegas, Nevada  📅 American Academy of Orthopedic Surgeons Annual Meeting     – Date: February 12-16     – Location: San Francisco, California  📅 RAPS Global Regulatory Strategy Conference 2024     – Date: March 5-7     – Location: Baltimore, Maryland  📅 HIMSS     – Date: March 11-15     – Location: Orlando, Florida  📅 American College of Cardiology’s Annual Scientific Session (ACC.24)     – Date: April 6-8     – Location: Atlanta, Georgia  📅 American Association of Neurological Surgeons Annual Meeting     – Date: May 3-6     – Location: Chicago, Illinois  📅 Society of Robotic Surgery Annual Meeting     – Date: June 20-23     – Location: Orlando, Florida  📅 American Diabetes Association’s 84th Scientific Sessions     – Date: June 21-24     – Location: Orlando, Florida  📅 North American Spine Society Annual Meeting     – Date: September 25-28     – Location: Chicago, Illinois  📅 American Society for Therapeutic Radiology and Oncology (ASTRO) Annual Meeting     – Date: September 29-October 2     – Location: Washington, D.C.  📅 AdvaMed’s The MedTech Conference     – Date: October 15-17     – Location: Toronto, Canada  📅 Cardiovascular Research Foundation’s Transcatheter Cardiovascular Therapeutics (TCT  2024)     – Date: October 27-30     – Location: Washington, D.C.  📅 American Heart Association Scientific Sessions     – Date: November 16-18     – Location: Chicago, Illinois  📅 Radiological Society of North America Annual Meeting     – Date: December 1-5     – Location: Chicago, Illinois  Each of these events offers exceptional opportunities to interact with industry leaders, explore the most innovative technologies, and gain invaluable knowledge. Be prepared to engage with the top professionals in the field, discover the latest technological innovations, and enrich your understanding.  Don’t miss the chance to be a part of these conferences that will play a pivotal role in shaping the future of medicine and technology. As Brisa Advisors, we reaffirm our commitment to providing expert regulatory support for the medical devices industry in Brazil and internationally.   Stay updated on the latest trends, regulations, and discoveries. Join us in 2024 to actively contribute to shaping the future of medical technology.  #RegulatoryAffairs #BrisaAdvisors #BPOinRA #MedicalDevices #MedicalTechnology #MedicalConferences #Innovation #Health #MedicalTrends    *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

Dear LinkedIn colleagues,  The medical devices industry continues to be a dynamic field of innovation, driven by the growing need for home care, preventive treatments, early diagnosis, and improved outcomes. Technologies such as Artificial Intelligence (AI), Augmented Reality, 5G, and digitalization play a crucial role in this evolution.  In the past three years, more than 450,000 patents have been registered and granted in the medical devices industry, as reported by GlobalData on Artificial Intelligence in Medical Devices: Treatment Assessment Models.  Check out the report here.  However, innovations in this industry do not follow a linear trajectory. Instead, they follow an “S”-shaped curve, representing their lifecycle, from emergence to maturity.  Identifying where an innovation stands on this journey is essential to understand its current adoption and future impact. According to GlobalData’s Technology Foresights, there are more than 150 areas of innovation that will shape the future of the medical devices industry.  In the emerging phase, technologies like AI-assisted radiology, motion artifact analysis, and treatment assessment models are revolutionizing the sector.  In rapidly advancing innovation areas, AI-assisted magnetic resonance image (EHR/EMR) smoothing and AI-assisted computed tomography are gaining momentum.  In maturing innovation areas, computer-assisted surgeries and 3D endoscopy are well-established.  AI is a driving force behind these innovations, and AI-based treatment assessment models are excelling. They enable physicians to recommend precise treatments, saving time and resources. Furthermore, GlobalData’s analysis identifies leading companies in this field, assessing the geographical reach and diversity of applications of their patents. More than 40 companies, including technology providers, established medical device companies, and emerging startups, are driving the development of these models.  Some of the key players include Smith & Nephew, Stryker Corp, Johnson & Johnson, Motorika, AlterG, and Novartis. AI is revolutionizing medicine, improving data collection, and treatment effectiveness.  This is an exciting time for the medical devices industry, with AI as a transformative force. The application of AI will lead to better clinical outcomes and more efficient allocation of healthcare resources, especially in times of budget constraints.  For a deeper understanding of these revolutionary trends and technologies, check out GlobalData’s latest thematic research report on Medical Devices.  #RegulatoryAffairs #BrisaAdvisors  #BPOinRA  #MedicalDevices #Innovation #ArtificialIntelligence #MedicalDevices #MedicalTechnology #AI #Healthcare #MedicalTrends  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br. 

Currently, in Chile’s regulations, there is no need for registration for medical devices except for a few cases. There are only 8 medical devices that must have mandatory registration in Chile, which are:  For products that do not require registration in Chile, we must obtain a Customs Destination Certificate (CDA), accompanied by the shipping document, commercial invoice, quality certificate, and a form that includes batch/serial numbers and expiration dates, if applicable.  Here is the information regarding latex rubber condoms:  INCORPORATES THE PRODUCTS INDICATED IN THE SANITARY CONTROL REGIME ESTABLISHED IN ARTICLE 111 OF THE HEALTH CODE AND SUPREME DECREE NO. 825, 1998, OF THE MINISTRY OF HEALTH  Exempt No. 93: Santiago, July 24, 2018.  “… incorporated into the sanitary control regime the following elements for medical use: single-use rubber surgical gloves, rubber gloves for medical examinations, and latex rubber condoms.”  “… verification of compliance with medical devices consisting of latex rubber condoms, incorporated by exempt decree No. 342, 2004, was carried out using the technical standards contained in Standard NCh 2224/1-2224/10of93, which have expired and it is necessary to accept the internationally valid version up to that point, which incorporates aspects related to primary packaging integrity, stability, incompatibility, and microbiological contamination studies.”  “… The said document also informs that exempt decree No. 342 defines mandatory control only for latex rubber condoms but does not include synthetic male condoms (nitrile, polyurethane, etc.) or female condoms, which is why the latter are not subject to sanitary control. The report also adds that it confirmed the technical and operational feasibility of the authorized certifying body to perform the analyses required by the new proposed standards.”  The products and elements for medical use listed below are incorporated into the control system established by Article 111 of the Sanitary Code and its regulations, approved by Supreme Decree No. 825, 1998, of the Ministry of Health:  The conformity assessment of these products must be conducted in accordance with the technical standards and specifications indicated and approved by this administrative act and the class assigned to them:  The above products can only be manufactured, imported, marketed, or distributed in the country if they have the corresponding certification of compliance with the applicable standards, granted by an entity authorized by the Institute of Public Health for this purpose.  #RegulatoryAffairs #BrisaAdvisors #BPOinRA #ChileanRegulations  #MedicalDevices #InternationalStandards #RegulatoryCompliance #PublicHealth  #HealthcareRegulation #QualityAssurance #TechnicalStandards #MinistryOfHealth  #SanitaryRegulation #ProductCertification #Condoms#ISOStandards  #MedicalCompliance #ExportToChile  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br. 

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. InternationalRegulation #ANVISA #InternationalDocuments #Consularization #Apostille #GlobalBusiness #RegulatoryCompliance #ForeignTrade #RegulatoryAffairs #BrisaAdvisors #BPOinRA *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br.

Hello, connections!  Today, I would like to share important information about the transfer of ownership in products or services certified by INMETRO. The National Institute of Metrology, Quality, and Technology is vital for product safety and quality in Brazil, but the transfer of ownership is not something directly regulated by INMETRO.  Ownership transfer is a crucial procedure to ensure that products continue to meet safety and quality standards. This is essential for both manufacturers and consumers, as it helps maintain the reliability of certified products.  To transfer ownership of a product certified by INMETRO, your company typically needs to follow legal and administrative procedures, such as updating the ownership record with the manufacturer or seller. INMETRO focuses on quality and compliance, while ownership transfer is a matter of property and contracts between individuals or companies.  Remember to check local laws and relevant regulations, as well as the policies of the specific product’s company or manufacturer, to ensure that your company is following the correct process. Typically, this involves updating registration information and providing appropriate documentation for the ownership transfer.  ✅ Why is it important?  Ownership transfer is necessary when a certified product changes ownership. This includes transfers from manufacturers to distributors, importers, or other manufacturers. It ensures that the new owner is responsible for the ongoing compliance of the product with INMETRO regulations.  ✅ How does it work?  The process of ownership transfer at INMETRO involves a series of steps, including updating documents, verifying product compliance, and issuing a new Certificate of Conformity. It is vital to follow all guidelines and deadlines established by INMETRO to ensure a smooth transition.  ✅ Benefits:  • Ongoing Compliance: Ensures that the product continues to comply with regulations.  • Clear Responsibility: Defines the new owner as responsible for compliance.  • Transparency: Facilitates tracking of certified products.  Make sure you are familiar with the procedure for transferring ownership of products certified by INMETRO. If you have any questions, please leave them in the comments.   below. Additionally, if you find this post informative, share it so that more people can understand the importance of ownership transfer in this context.  #INMETRO #Certification #OwnershipTransfer #Compliance #Safety #Quality #Regulation  *Schedule a meeting at MEDICA Düsseldorf, Germany 13 – 16 November 2023   *Budget for the registration ownership transfer, Market Access Strategy and BPO in RA services for your company: www.brisa.com.br