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 

The medical device industry is rife with complex regulations that vary by geographical region. Understanding the differences between the leading regulatory agencies is essential for success in the global medical device market. Here’s a comparative analysis of FDA, ANVISA, and MDR classifications and regulations.  ASPECT  FDA (USA)  ANVISA (Brazil)  MDR (EU)  Classifications  Class I, II, III, IV  Class I, II, III, IV  Class I, IIa, IIb, III  Approval Process  Pre-Market (510(k), PMA)  Registration, Authorization  Conformity Assessment  Clinical Evaluation  Required for some classes  Required for some classes  Required for some classes  Labeling Requeriments  Strict  Strict  Strict  Registration Validity  Not Required  Class I and II – Indeterminate  Class III and IV – 10 years  Periódica (5 anos)  Local Technical Responsible  Not Required  Required  Required  Post-Market Requeriments  Surveillance e Recalls  Surveillance e Recalls  Surveillance e Recalls  Regulatory Authorithy  FDA  ANVISA  European Comission  Jurisdiction  United States  Brazil  European Union  Legend:  Class I: Low-risk medical devices. Class II: Moderate-risk medical devices.  Class III: High-risk medical devices. Class IV: Maximum-risk medical devices.  Observations:  It’s crucial to understand these differences when bringing medical devices to specific markets. Regulatory compliance is essential for ensuring patient safety and product success.  ANVISA ultimately determines the classification of a medical device for marketing in Brazil. Materials, equipment, orthopedics, and IVDs have their respective standards, RDC 751/2022 and RDC 36/2015, which determine how products should be classified and how models should be grouped into families, kits, or systems. At BRISA ADVISORS, we offer a free classification service and determination of the regulatory pathway upon receiving product usage instructions at contactBR@brisa.com.br.  #MedicalDevices #Regulations #Health #FDA #ANVISA #MDR  Disclaimer: This post is for informational purposes and does not replace consultation with the official regulations of the corresponding regulatory agencies. Always consult official sources for precise and up-to-date guidance.  *Schedule a meeting at MEDICA Düsseldorf, Germany, from November 13 to 16, 2023.  Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br  * Budget for the registration ownership transfer, Market Access Strategy and BPO in RA services for your company: www.brisa.com.br 

The National Health Surveillance Agency (ANVISA) plays a vital role in Brazil, regulating products and services related to health. In an ever-evolving world, regulatory compliance is the backbone of patient safety and business success. When it comes to regulatory compliance, choosing the right Hosting Service is crucial.  In the recent past, it was common for foreign manufacturers to delegate this strategic function entirely to their local distributor. However, over time, it became evident that the consequences of this choice could be very costly for the manufacturer. During these last three decades of regulatory consulting, we at Brisa Advisors have witnessed cases of manufacturers being pushed out of the market due to commercial conflicts with their distributors. Some were unable to expand their distributor networks, missing out on significant market opportunities. We’ve seen instances of techno-vigilance where distributors chose to defend themselves before ANVISA instead of the manufacturer’s interests. We even followed a case where a competing manufacturer acquired the local distributor, holding the registrations of their global competitor, and canceled existing ANVISA registrations, taking that player out of the Brazilian market for several years and capturing their market share.  Professional Hosting Service options emerged back in 2003 with the publication of RDC No. 1 on January 6, 2003. This resolution regulated the Importation of Goods by companies without product regularization documents before ANVISA, through a declaration from the company holding the registration authorizing another importer to use its registration. Since then, many consulting companies have established import companies with the goal of hosting medical device registrations in Brazil.  Amidst numerous options in the market, it’s important to consider some key points:  1. How many years of regulatory market experience does the company have?  2. Financial stability.  3. Ability to transfer ownership at any time as specified in the contract.  4. Secure Document Storage: ANVISA requires companies and organizations to submit regulatory documentation for product approval or registration. A hosting service should offer secure and reliable storage for these documents, ensuring they are accessible and protected.  5. Compliance with Brazilian Regulations: The hosting service must comply with relevant Brazilian regulations, such as ANVISA standards, to ensure that the stored data and documents align with legal requirements.  6. Data Security: ANVISA deals with sensitive health-related information. Therefore, data security is critical. Ensure that the hosting provider has stringent data security measures in place, including encryption, user authentication, and access control.  7. Data Backup and Recovery: Having an effective data backup and recovery strategy is important to ensure that regulatory documentation is not lost in the event of hardware failure or other incidents.  8. Availability and Performance: The availability and performance of hosting systems are essential to ensure that documents can be accessed and submitted to ANVISA in a timely manner, especially when dealing with regulatory deadlines.  9. Specialized Technical Support: It is important that the hosting provider has knowledge and experience in dealing with ANVISA regulatory matters to provide proper technical support and assistance in resolving compliance-related issues, as well as supporting INMETRO and ANATEL certifications.  10. Audit and Tracking: The ability to audit and track activities related to regulatory documents is crucial to comply with compliance requirements.  Whether you are seeking product approval, assistance in maintaining compliance, or simply want to better understand the ever-changing regulatory landscape, we are here for you.  At Brisa Advisors, we understand the challenges you face, and we are committed to simplifying this challenge for you!  Contact us today and discover how we can be your trusted partner in regulatory affairs.  #ANVISA #Regulation #Compliance #PublicHealth #Hosting #DataSecurity #LinkedIn #RegulatoryConsulting  *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 

The term “BPO” refers to “Business Process Outsourcing,” and in the context of regulatory compliance services within an organization, there is a growing trend of Regulatory BPO services. This service model involves outsourcing some or all of the regulatory and compliance functions of a company to an external service provider. These services can include regulatory document management, compliance reporting, monitoring evolving regulations, and other activities related to compliance with government standards and regulations.  Outsourcing these activities can allow companies to focus on their core competencies and reduce costs, as regulatory compliance experts can handle specific tasks related to regulations, standards, and industry-specific requirements. Regulatory BPO is common in highly regulated industries such as pharmaceuticals and medical devices, where regulatory compliance is critical to business success and can be complex and constantly evolving.  While they have similarities, BPO and outsourcing are not the same thing. Outsourcing refers to delegating a specific task to another company. On the other hand, BPO goes beyond delegating one or two tasks and involves outsourcing entire business processes. For example, if a company wants to create a new logo for its business but doesn’t want to hire a designer, it can outsource the logo creation to an agency or a freelance professional. This is outsourcing. BPO, on the other hand, would involve hiring another company to handle all aspects of visual communication and graphic design.  This is the essential difference between the two. Additionally, BPO often comes with a higher cost than outsourcing since it encompasses a broader range of services. Also for this reason, BPO providers typically offer more innovative solutions with a higher degree of technological sophistication.  With BRISA’s BPO in RA, your company gains access to all possible regulatory services, including:  * Budget for the registration ownership transfer, Market Access Strategy and BPO in RA services for your company: www.brisa.com.br 

Among medical products, the orthopedic category refers to a broad range of devices and equipment designed to assist in the prevention, diagnosis, treatment, and rehabilitation of conditions related to the musculoskeletal system. These products are developed to support mobility, alleviate pain, correct deformities, and enhance the quality of life for patients with orthopedic injuries, illnesses, or disorders.  Some examples of orthopedic medical products include:  Just like medical devices, orthopedic materials are classified by risk according to RDC No. 751/2022. Therefore, it is necessary to assess the usage instructions and their specificities in order to determine if conformity certificates, such as INMETRO certification, are required.  Regarding orthopedic implants, this category encompasses all implantable medical products with orthopedic purposes, which are directly used for joint replacement, bone synthesis, ligamentoplasty, and functional maintenance of the human spine. Similar to in vitro diagnostic devices, it is possible to group them into   families and systems for registration purposes, with RDC No. 59/2008 being the resolution that establishes the procedures to be followed.  Concerning the registration of orthopedic products with ANVISA, the technical dossier is assembled based on the product’s risk class. It is crucial to construct well-prepared documents in order to avoid rejection of the process by the Health Surveillance. Among common causes of rejection, the following can be listed:  Ensuring that the technical dossiers and information meet the required specifications is essential to prevent the loss of financial resources in new processes and also to save time, especially as of September 2023, when the waiting time for the analysis queue for the registration of implantable orthopedic materials is 9 months.  * Budget for the registration ownership transfer, Market Access Strategy and BPO in RA services for your company: www.brisa.com.br 

Health products play a crucial role in modern society, directly contributing to the well-being and quality of life of individuals. These products range from medical devices to dietary supplements and over-the-counter medications, providing a wide array of therapeutic and preventive benefits. The significance of these products lies in their ability to treat illnesses, alleviate symptoms, and promote health, enabling people to lead healthier and more productive lives. However, due to their direct influence on public health, it is imperative that these products be rigorously regulated. Regulation ensures the effectiveness, safety, and quality of the products, safeguarding consumers from potential risks and ensuring that the benefits outweigh any potential harm.  Among medical devices, we have products for in vitro diagnostics, equipment, instruments, and also software as a medical device. According to RDC No. 751/2022, Software as a Medical Device (SaMD) is considered a medical device that performs its functions without being part of the hardware of a medical device, having the following specificities:  Just like medical devices in general, SaMD needs to undergo a risk classification to determine the type of documentation that must be submitted for registration with ANVISA – ensuring its commercialization. The classification follows RDC No. 751/2022, and depending on the intended use of the device, the risk classification can vary between Class I, II, III, and IV.  Regarding the regularization of SaMD, RDC No. 657/2022 is used as a reference, and it outlines the requirements for labeling and instructions for use, as well as the requirements for assembling technical dossiers – according to the associated risk class.  In the case of Class III and IV SaMDs, the technical dossier must include a declaration of conformity with international standards or their national versions. Among these requirements, the declaration must contain at least the following versions:  On October 19, 2022, ANVISA also provided a file with the main questions and answers regarding RDC 657/2022, which can be accessed at this link: https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2022/software-como-dispositivo-medico-perguntas-e-respostas