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 

Medical devices play a fundamental role in the practice of modern medicine, offering a variety of essential tools for diagnosis, treatment, and monitoring of health conditions. These devices range from simple equipment such as thermometers and glucose monitors to advanced technologies like magnetic resonance imaging and medical implants. By enabling early disease detection, enabling less invasive procedures, and ensuring more efficient monitoring, medical devices contribute significantly to the advancement of health and well-being of the population.  Among the various types of medical devices – as defined by RDC nº 751/2022 – in vitro diagnostic medical devices stand out due to their multiple applications in the healthcare field. Because it is a complex and specialized regulatory subject, in vitro diagnostic products (IVDs) are governed by a specific resolution: RDC nº 36/2015.  By definition, an IVD is a reagent, software, sample collector, or other article used for the in vitro analysis of samples derived from the human body, exclusively or primarily, with the purpose of providing information for diagnostic, monitoring, compatibility, screening, or determination of physiological status.  The classification is carried out following the guidelines of RDC nº 36/2015, according to the most applicable rule for the product. Following this analysis and determination of the class, the process of petitioning for notification or registration with ANVISA begins.  The classification establishes the type of process that will be submitted: IVD products of Class I and II are subject to notification, while those of Class III and IV are subject to registration. In the case of notifications, the technical analysis of documents by ANVISA constitutes a more simplified process. Specifically for Class I, it is not   necessary to prepare a technical dossier, only to submit certain information. For products targeted for registration, it is necessary to submit, in addition to the technical dossier, a Good Manufacturing Practice (GMP) Certificate process to ANVISA as a prerequisite.  According to Regulatory Instruction nº 3, dated August 26, 2015, in vitro diagnostic medical devices that are included in a grouping list for IVD families can be registered or grouped as a family, provided that a series of requirements are met. These include the stipulation that they must be products of the same composition, technology, legal manufacturer, and intended for interdependent and exclusive use.  Furthermore, besides the mentioned documents, an IVD product may also require a Conformity Certificate (ANATEL, INMETRO) or a pre-analysis report deemed satisfactory by a unit of the National Network of Public Health Laboratories. This applicability should be evaluated on a case-by-case basis, according to the specificities of the product.  * Budget for the registration ownership transfer, Market Access Strategy and BPO in RA services for your company: www.brisa.com.br 

The INCQS (National Institute for Quality Control in Health) is an entity linked to the Oswaldo Cruz Foundation (Fiocruz) in Brazil, dedicated to quality control in health-related products and services. The institute conducts analyses, tests, and certifications to ensure the quality and safety of products regulated by the National Health Surveillance System, which is part of the Unified Health System (SUS), such as medicines, health products, food, diagnostic kits, dialysis articles and supplies, cosmetics, among others.  The Institute carries out its responsibilities by conducting laboratory analyses of products subject to health surveillance; establishing new quality control methodologies; promoting regulatory actions in partnership with Health Surveillance; training professionals and providing technical assistance to the quality control laboratory network. These competencies are provided for in Article 28 of Decree No. 4,725, dated 06/09/2003, which approves the Statute of the Oswaldo Cruz Foundation – FIOCRUZ.  The analyses carried out at the Institute (chemical, physical, physicochemical, toxicological, immunological, pharmacological, microbiological) can be classified as regulatory, preliminary, control, guidance, and special analyses.  At the conclusion of laboratory analysis for any product and for any of the aforementioned modalities, a report is issued and sent to the requester.  Among the conformity certificates mentioned in other articles, such as INMETRO and ANATEL, the INCQS certificate differs in that it does not need to be submitted as a prerequisite for product notifications or registrations in the healthcare sector. This certificate is required by ANVISA during the submission analysis, where the type of analysis to be performed is indicated, along with the necessary steps. 

Conformity certificates are documents issued by certification bodies or accredited entities that attest that a product, process or system complies with certain norms, regulations or specific standards. These certificates are used to demonstrate that a product and/or service meets quality, safety performance and other criteria established by technical standard or applicable regulations.  Evaluating the conformity of a product means verifying that it is produced according to the minimum necessary requirements. INMETRO, a Brazilian federal agency linked to the Ministry of Economy – is, Brazil, the Brazilian body responsible for establishing conformity assessment programs.  INMETRO is responsible for implementing metrology, quality and compliance policies in Brazil. It designs, develops and applies the technical standards necessary to guarantee the safety, quality and efficiency of the products and services offered in the Brazilian market.  The INMETRO Certificate is often associated with products that are subject to regulation and mandatory certification, such as home appliances, toys, tires, safety equipment, light bulbs, among others, including electromedical equipment, through Ordinance 344/2020. Obtaining the certificate involves laboratory tests, conformity analyzes and evaluations according to the norms established by INMETRO or by bodies accredited by it.  In the Brazilian Conformity Assessment System, there are two types of certification: Voluntary Certification – which the company defines whether or not to certify its product – and Compulsory, in which a regulation determines that the company can only produce/market a product after it is certified. The specific legislation dealing with Certification is RDC No. 27, of June 21, 2011.  The Resolution 27/2011 establishes that the procedures for compulsory certification of equipments under the Sanitary Surveillance regime for:  Equipment outside these classifications is voluntarily certified.  ABNT NBR IEC 60601-1 discusses the general requirements for basic safety and essential performance of medical electrical equipment, not being applicable to in vitro diagnostic equipment that does not fit the definition of ME EQUIPMENT, which are addressed by the IEC 61010 series and implantable parts of active implantable health products, addressed by the ISO 14708 series.  The Regulatory Standard deals with the basic safety requirements and essential performance of electrical medical equipment and serves to ensure that no individual electrical, mechanical or functional failure poses a risk to whoever is operating or the patients who will receive treatment or will undergo an examination or procedure. 

Conformity certificates are issued by accredited organisms and attest the compliance of products, processes or systems with specific standards. They prove quality, safety and performance following applicable regulations. Among the different types of certificates of conformity, ANATEL certification is also widely used in health products.  ANATEL is the regulatory agency responsible for supervising and controlling the telecommunications sector in the country, and its certification guarantees that devices meet the quality and safety standards established by Brazilian technical standards. The certification process aims to guarantee that these products do not interfere or harm the operation of other devices and telecommunications networks, as well as that they are safe for consumers to use.  The Regulation for Conformity Assessment and Homologation of Telecommunications Products, approved by RDC No. 715 of October 23, 2019, establishes that the issuance of the homologation document is a mandatory prerequisite for the marketing and use of telecommunications products in Brazil.  In addition, with regard to health products, the ANATEL certificate is compulsory for products that contain specificities, including:  The products are classified into 3 categories (1, 2 and 3) and the Designated Certification Bodies (OCD) are responsible for evaluating the product and classifying it according to the classifications already defined by the agency. Only organizations listed on ANATEL’s official website can issue such certification – they can be accessed at this link.  Medical products that fit into the above categories must present an approval certificate from Anatel (National Telecommunications Agency) or a test and test report that proves the safety of these devices, ensuring that the radiofrequency and electromagnetic field emissions are within the limits established by regulation.  Anvisa even warns that manufacturers and importers follow the duty to comply with all obligations determined by Anatel, such as Resolution No. 680, of June 27, 2017, which approves the Regulation on Radiocommunication Equipment with Restricted Radiation. 

The Hospitalar, the main health sector fair in Latin America, is moving towards its 29th edition, to be held from May 21 to 24, 2024, at São Paulo Expo. The event brings together professionals from the health market – both national and international – and aims to boost the technological advances achieved in the sector, foster new business opportunities and promote numerous spaces for debates, lectures and forums on the main issues and trends in the health sector.  Why exhibit at Hospitalar?  However, how to expose a medical product that is still not registered or notified by ANVISA?  In this case, it is possible to carry out a temporary admission – as established in ANVISA’s RDC No. 208/2018. By preparing a document for each product to be displayed, the applicant must enter some information, such as date and location of the event in which the medical product will be displayed, proof of purpose, in addition to having an associated technical manager during the stay of the product in the national territory.  Once it is authorized, it is then possible to exhibit your products at the fair informed during the request. This procedure provides numerous benefits to the applicant, including:  Upon obtaining the authorization document provided by ANVISA, it is important to emphasize that it does not allow any commercialization or use of the medical product until the due regularization (registration or notification) with ANVISA is made.  Be sure to exhibit at the largest medical products fair in Latin America. Get in touch with us to obtain temporary admission with ANVISA and leverage your business!