RDC 850/2024 was published today, which amends RDC 497/2021 in its Article 8 with the inclusion of information that manufacturers adhering to the MDSAP program now have GMP Certification valid for 4 years, as long as they remain members of the program with certification valid for the same period. It is worth noting that RDC 497/2021 provided for a generic validity of two years for any manufacturer, whether or not part of the MDSAP. If your company has MDSAP certification and does not yet do business in Brazil, take the opportunity to sail into a blue ocean of opportunities! Our team of experts is ready to understand your expectations and operate your entry into the Brazilian market with excellence. Schedule a call today! To read the translated version of RDC, click here.

Anvisa has recently announced an update to safety and performance requirements for medical devices, including in vitro diagnostic devices (IVDs), through RDC 848/2024. This measure, approved in the last meeting of the Collegiate Directorate (Dicol) on Wednesday (06/03), brings significant advancements since the replacement of the previous standard, RDC 56/2001.  What’s Changing? With technological advancements over the last 23 years, the new resolution aims to adapt regulations to innovations in the field of medical devices. The updated requirements seek to enhance technical assessment by Anvisa, addressing the challenges posed by new technologies and the diversity of devices.  One of the benefits of this update is enhanced guidance for manufacturers: they will have clear guidelines on the studies and evidence required for product registration, increasing the robustness of the submitted documentation.  Regulatory Harmonization: This move by Anvisa also aligns with efforts towards regulatory harmonization in Mercosur, adopting the Mercosur Technical Regulation based on the guidelines of the International Medical Device Regulators Forum (IMDRF).  In addition to updating essential safety and performance requirements, the new RDC also incorporates the Mercosur Technical Regulation into the national legal framework, repealing Resolution GMC 72/98.  For manufacturers and healthcare professionals, this is a good time to familiarize themselves with the new guidelines and ensure their products and practices are fully compliant.   #RegulatoryAffairs #BrisaAdvisors #BPOinRA#Anvisa #MedicalDevices #Regulation #Health #MedicalTechnology  Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

Only in public bids mapped by our bid tracking system did we find more than 45 million in sales for this kit in 2023. This value does not include private institutions. Count on our team of experts to file your request for Good Practice Certification and register your products for Dengue detection. Schedule a call with us now! #ivd#medicaldevices#regulatoryaffairs#ANVISA#dengue Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

Recently, the National Health Surveillance Agency (Anvisa) issued an informative statement regarding the use of smartwatches for glucose monitoring. This news has sparked discussions about the applicability and safety of these devices in health management, especially for people with diabetes.  In the statement, Anvisa emphasizes that there are currently no registered or authorized medical devices in Brazil for glucose monitoring through smartwatches. This raises significant questions about the reliability and accuracy of the results obtained from these devices.  It is important to note that accurate and reliable glucose monitoring is crucial for proper diabetes control and treatment decision-making. Therefore, the use of unregulated devices may pose a health risk to users.  Anvisa reinforces the need to consult qualified healthcare professionals for proper glucose monitoring and for choosing appropriate and safe devices. Additionally, it highlights the importance of following current guidelines and regulations to ensure safety and effectiveness in healthcare.  In light of this, it is essential for users to be aware of the limitations and necessary precautions when using glucose monitoring technologies, always seeking up-to-date and reliable information.  For further details and information, we recommend reading the full official statement from Anvisa, available on our blog. Check it out!  https://lnkd.in/eaRRciFy  #RegulatoryAffairs #BrisaAdvisors #BPOinRA #MedicalDevices  #MedicalTechnology  Find out more about BPO in RA!  *Budget for registration ownership transfer, Market Access Strategy, and BPO in RA services for your company: www.brisa.com.br 

1 – I have products registered in the name of my distributor or even in the name of acompany that hosts registers. Is it possible to make another registration of these sameproducts, i.e., having the same product registered twice by different companies(registration holders)?BRISA ADVISORS: Yes, it is possible to have the same product registered by more thanone registration holder at ANVISA. But also, it is possible to transfer ownership of classIII and IV products when the current registration holder agrees with this procedure. 2 – In which cases can I request the transfer of ownership of registers?BRISA ADVISORS: In corporate and commercial operations between companies thatcarry out activities subject to sanitary control – ANVISA, which implies the change ofownership of product registration, since the conditions and technical-sanitarycharacteristics of companies, products and clinical trials are kept. 3 – Which are the definitions adopted by RDC No. 102/2016?BRISA ADVISORS:I – technical and health characteristics: regular conditions of the product, company, orclinical trial at ANVISA, immediately before the corporate or commercial operation;II spin-off: corporate operation in which a legal entity transfers parts of its property toone or more legal entities established for this purpose, or already existent, extinguishingthe demerged company if all its assets are transferred, or dividing the capital if thetransfer is partial;III – succeeded company: legal entity that transfers to the successor company the rightsand obligations on the product object of registration transfer, the establishment, or theresponsibility for clinical testing as a result of corporate or commercial operations;IV – successor company: legal entity that now has the rights and obligations on theproduct object of registration transfer, the establishment, or the responsibility forclinical testing as a result of corporate or commercial operations;V – merger: corporate operation in which two or more legal entities are merged to createa third one, succeeding them in all rights and obligations;VI – incorporation: corporate operation in which one or more legal entities are absorbedby another one, succeeding them in all rights and obligations;VII – commercial operation: operation between companies resulting in the sale of assetsor group of assets, without the occurrence of any corporate transaction between thecompanies involved;VIII – corporate transaction: corporate action involving the merger, spin-off orincorporation under Law no. 10,406, of January 10th, 2002, and, in a subsidiary manner,Law no. 6,404, of December 15th, 1976;IX – Mercosur representative: company located in the Receiving State Party [EstadoParte Receptor (EPR) in Portuguese], which is contracted to represent a registrationholder in the Producing State Party [Estado Parte Produtor (EPP) in Portuguese] andassumes the legal and technical responsibility in the EPR;X – global transfer of responsibility for clinical testing: modification characterized by thechange of the applicant of clinical trial dossiers, notification of clinical testing, dossiersof clinical development of drugs (DDCM), dossiers of clinical investigation of medicaldevices (DICD), expanded access programs, compassionate use programs and supply ofpost-study drug, in cases of corporate or commercial operations, without any change oftechnical and health characteristics contained in the Specific Special Communiqué[Comunicado Especial Específico (CEE) in Portuguese], Document for the Import ofProduct under Investigation or Special Communiqué), object of change;XI – transfer of registration holder: modification characterized by the change of theregistration holder of products subject to health surveillance, in case of corporate orcommercial operations, without any change of technical and health characteristics inthe registration of product object of transfer. 4 – In cases of commercial or corporate operations carried out abroad, does this RDCalso apply?BRISA ADVISORS: Only in cases where these operations carried out abroad imply theneed to update data at ANVISA by the registration holder in Brazil, such as updating theCBPF or in case of alteration in the registers of existing products to communicate withthe new manufacturer. 5 – Can the Certificate of Good Manufacturing Practices (CBPF) and the Company’sOperating Permit (AFE) be transferred along with the registration of the product?BRISA ADVISORS: In fact, already published BPF certificates can have their updatedregistration data for the new applicant, provided that the previously examinedtechnical-health characteristics, whenever the corporate or commercial operation ofregistrations of already deferred products. The validity of the certificate does notchange, it will remain the same as the initial order made by the succeeded company.For initial requests of CBPF that are still awaiting or with analysis not yet completed, itwill not be possible to update the registration data. The succeeded company mustpromote the addition of the petition to update the documentation, with a view toinstructing and continuing the analysis of the petition in progress.The AFE may be updated through a petition for amendment, cancellation, or concession,whenever there is a corporate transaction that will result in a new person legal entity,or when there is already a legal entity not regularized with the surveillance health,regularization will always be through an initial grant request for AFE.It is important to point out that the Certificate of Good Manufacturing Practices aregranted for each establishment, by production line. When the succeeded company’soriginal certificate must be maintained, the successor company must request on itsbehalf a new certificate for the line involved. This situation may lead to a new sanitaryinspection.6 – Which are the deadlines that must be watched?BRISA ADVISORS:a) 180 days: For requests for transfer of ownership and cancellation of registration ofhealth products, which must be concurrently filed with ANVISA, respectively by thesuccessor and succeeded company, the period is up to 180 (one hundred and eighty)days from the date of filing of the corporate act registered with the board of trade or ofthe celebration of the contractual instrument of the commercial operation, or, in thecase of a representative Mercosur, will be counted from the date on which theinterruption of the contractual relationship between the parties contained in theDeclaration (Annex I of the RDC 102/2016) is formalized.b) 180 days: Companies will have a maximum of one-hundred and eighty (180) days tosell out the remaining stock of finished products after the entry into force of Resolutionsof cancellation and transfer of registration.c) 90 days: Resolutions of cancellation and transfer of ownership registration of productssubject to health surveillance addressed in this resolution shall come into force ninety(90) days after its publication and