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

Being the registration holder itself, or having a company specialized in hosting these registrations in markets where it operates is strategic for any manufacturer of Medical Devices. In Brazil, it is fundamental to have a competent and reliable company that can defend the manufacturer’s interests with ANVISA regarding regulatory issues. An eventual dispute of commercial interests between distributors and the manufacturer can result in the loss of ‘’marketshare’’ by having to stay months or even years off the market until registration are reestablished. Since 1995, acting as consultants in regulatory matters, we have seen it all. Companies that were expelled from competition by purchasing the distributor in Brazil who was the registration holder for the entire product line of their main competitor, commercial conflicts that resulted in the cancellation of registrations and also companies that act as registration holders, but are more bureaucratic than ANVISA and make the simple issuance of an import authorization letter a barrier to the commercialization of products. It is for these and other situations that changes the daily routine of foreign manufacturers in a real challenge that the BRISA ADVISORS group – through its host registration company BIHS – launched the service of Business Process Outsourcing-BPO – which includes a full service through a simple service subscription. It is the embodiment of the One-Stop Shop term, with the advantage of previsibility of the annual budget that the subscription club model provides. To promote these services, we will publish the main doubts of our clients regarding different topics, starting with transferring ownership of registrations that allows you to guarantee and maintain access to the market safely and quickly! Brazilian legislation allows registers to be transferred to another company for reasons of corporate operations such as merger, spin-off, incorporation or even for the sale of assets. RDC No. 102/2016 which deals with transferring ownership of products subject to Sanitary Surveillance regulated the commercial operation defined as ‘’operation between companies resulting in the sale of assets or group of assets, without the occurrence of any corporate operation between the companies involved.’’ For more information on the subject, visit our FAQ on the subject.