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! 

FAQ  The word “dismissed” may appear during some process request from ANVISA, so it is important to know what the term means so that you have the tools to act appropriately, in order to gain registration with the regulatory agency.  When a request is dismissed it means that it has been denied. Therefore, you will not be able to finalize your order because some problem prevented it from continuing. The reasons for the rejection can vary greatly, depending on the type of request or the proposed action.  Lack of proof of safety and efficacy requirements in accordance with RDC No 546/21.  Health products must be designed and manufactured in such a way that its use does not compromise the clinical status and safety of patients, nor the safety and health of operators or -  where applicable, other people, when used under the conditions and purposes provided.  The existing possible risks must be acceptable in relation to the benefit provided to the patient and must be reduced to a degree compatible with the protection of health and safety of people.   Failure to comply with RDC No 185/01 due to the absence of document required by current regulations (free trade certificate applicable to all models object of the petition)  RDC No 185/01, replaced by RDC 751/22, establishes that, for imported medical products, it must be presented for registration purposes, proof of registration or free trade certificate or equivalent document, granted by the competent authority of countries where the medical product is manufactured or commercialized.  It should be observed whether the document was prepared by the competent authority of countries where the medical product is marketed or manufactured, as recommended by the current resolution. Thus, not having been issued by the competent sanitary authority, the document does not meet the criteria established by the same.  We emphasize that the document must be submitted to Hague Apostille or Consularized at the Brazilian Embassy in the country of origin and, if the document is not fully written in Portuguese, Spanish or English, it must be accompanied by a sworn translation into Portuguese.  A copy containing the apostille or consular legalization of the following documents indicated in Part 3 of Technical Regulation of the RDC No 185/01, mandatory for the purposes of registration of imported medical products, was not presented: proof of registration or free trade certificate or document equivalent; and manufacturer’s declaration.  The Manufacturer’s Declaration is the document by which the Legal Manufacturer expressly authorizes the registration holder company to represent and commercialize itsr products in Brazil, in addition to declaring that it knows and meets the requirements of Good Manufacturing Practices for Health Products established in the RDC No 665/22, or regulation that replaces it. This statement must:  Did not comply with Circular Letter No. 1/2022/SEI/GGTPS/DIRE3/ANVISA, not presenting the documents digitally signed by the Legal and Technical Officers in accordance with the company’s AFE.  In 2022, ANVISA determined through the Circular Letter No. 1/2022/SEI/GGTPS/DIRE3/ANVISA that the signatures of the Legal and Technical Responsible for all submitted documents should be replaced by the Digital Certificate in the ICP-Brasil standard, in order to guarantee the integrity and authenticity of the documents object of the submissions. To ensure that the signatures are duly valid, we recommend that the documents have their signatures validated on the website http://validar.iti.gov.br, which is the official validator of the Brazilian Government. This is the only way to ensure that summary rejections due to signature errors will be avoided.  On the other hand, there are some cases where we can have a rejection for the same reason, with a valid signature on iti, but that was signed by someone else, other than the RT or the current legal representative. This can occur when the AFE is not yet up to date, and the Technical Representative has changed recently. 

FAQ  1 – What is the Brazilian Good Manufacturing Practices (BGMP) Certificate? Who does the BGMP Certificate apply to?  BRISA ADVISORS: The Brazilian Good Manufacturing Practices Certificate is the document issued by ANVISA attesting that a given establishment complies with Good Manufacturing Practices. The Certificate is issued per manufacturing unit, covering the production lines, pharmaceutical forms, special therapeutic classes and/or risk classes of products for which the company was inspected, and applies to companies manufacturing Medicines, Health Products, Cosmetics, Perfumes, Personal Hygiene Products and Pharmaceutical Supplies located in the national territory, in Mercosur or in other countries, as defined in specific norms.  2 – What ANVISA norm regulates the BGMP Certificate for products subject to sanitary surveillance?  BRISA ADVISORS: RDC No 665/2022: Consolidates the technical regulation  of Good Manufacturing Practices and Distribution and Storage of medical products and products for in vitro diagnosis.  RDC No 687/2022: Provides the criteria for granting or renewing of BGMP Certificate for Medical Devices.  The norm that regulates the GMP and Distribution and/or Storage Certificate is RDC No 497/2021. This resolution aims to establish administrative procedures for granting GMP Certificate for Medicines, Health Products, Cosmetics, Perfumes, Personal Hygiene Products, Sanitizing Products, Active Pharmaceutical Inputs and Food and also the Good Distribution and/or Storage Practices of Medicines, Health Products and Active Pharmaceutical Inputs.  3 – Is the Brazilian Good Manufacturing Practices Certificate mandatory for the operation of a company?  BRISA ADVISORS: It depends. Companies manufacturing products subject to sanitary surveillance must, obligatorily, comply with Good Practices, following the practices and procedures established in specific ANVISA rules.   If the company is manufacturing medical devices classified in class III or IV, the BGMP Certificate is mandatory  4 – What is the validity of a BGMP Certificate?  BRISA ADVISORS: The Brazilian Good Manufacturing Practices Certificate will be valid for two years, counting from the date of its publication in the Federal Official Gazette (DOU).  5 – What are the procedures adopted for granting the Certificate?  BRISA ADVISORS:  NACIONAL CERTIFICATE  In the case of national companies, the inspection is carried out by the Health Surveillance Offices of the States, Municipalities or Federal District.  1st STEP – Upon receiving the certification request, ANVISA’s technical area will consult the internal database to verify if there is a recent inspection carried out for that company.  2nd STEP – If no inspection is planned, the Agency sends an official letter to the Health Surveillance Office requesting an inspection.  3rd STEP – After the letter arrives at the local Health Surveillance, it will be up to it, according to its schedule and planning, to define the date of the inspection.  4th STEP – For the Certification, technical items from all sectors of the companies are evaluated. In the case of manufactures, for example, the warehouse, utilities (water and air systems, etc.), production, quality control, quality assurance, among other points addressed in the specific norms published by ANVISA, area analyzed.  5th STEP – Generally, the inspection team meets at the end of the inspection to consolidate the information and observations to support the preparation of the inspection report and conclusion regarding the inspection result.  6th STEP – After reaching a consensus, the report is delivered to the company, either at the inspected company or at the Health Surveillance, depending on local procedures.  7th STEP – Health Surveillance will send the inspection report to ANVISA according to its own procedures and schedules. The report is then evaluated by the Agency to support the analysis of the Certification petition.  ‘’ANVISA recommends that the interested party contact Health Surveillance, which will carry out the inspection in order to speed it up, informing: details of the company to be inspected; file number of the certification request at ANVISA; and lines, pharmaceutical forms, special therapeutic classes and/or risk classes of the products to be inspected.’’  MERCOSUR  In the case of companies headquartered in Mercosur countries that wish to sell medicines, biological inputs or health products in Brazil, the inspection is carried out only as a last resort, as there is a cooperation agreement in which the authorities exchange reports to be evaluated. If in doubt, questions are asked. If not answered, they are reiterated. Thus, only as a last resort is a joint inspection carried out with the health authority of the country where the manufacturer is headquartered.   Despite the exchange of information and reports between Mercosur member countries, there is no mutual recognition of certificates.  INTERNATIONAL  1st STEP – Upon receiving the certification request, ANVISA will analyze the requested documents, verifying if the documentation is sufficient to allow planning the inspection.  2nd STEP – If so, the inspection is scheduled. Otherwise, companies requesting inspection are required.  3rd STEP – Once the inspection can be carried out, a date for the inspection is negotiated. After that, the responsible area at ANVISA will set up the schedule and start defining inspection teams, usually composed of two technicians. The composition of the team and the performance of the inspection must be approved by the Collegiate Board of ANVISA (Dicol).  4th STEP – Once the inspection is approved, the teams are summoned and the removal process begins, that is, flight planning, hotel reservations, among others. After the inspection is planned, the team heads to the country where the company to be inspected is located.  5th STEP – During the inspection, technical items from all sectors of the companies are evaluated. In the case of manufactures, for example, the warehouse, utilities (water and air systems, etc.), production, quality control, quality assurance, among other points addressed in the specific norms published by ANVISA, are analyzed.  6th STEP – After the inspection, the report is delivered to the requesting company after the inspection team returns to Brazil, with one of the following technical opinion:  I – Satisfactory, being forwarded to Certification;  II – On demand, the deadlines set forth in RDC No 497/2021 must be complied with; or  III – Unsatisfactory. In this case, imports may be interrupted (in the case of products already registered) or