Important Update! In March 2024, the National Health Surveillance Agency (ANVISA) announced a crucial update: the list of technical standards for the certification of compliance of equipment under Health Surveillance has been revised. This measure is essential to keep pace with technological advancements and regulatory changes, ensuring that products marketed in the Brazilian market meet the latest safety and quality standards.  This update represents a significant milestone for the healthcare equipment industry and for all professionals involved in the regulation and oversight of Health Surveillance. It demonstrates Anvisa’s ongoing commitment to promoting the safety and efficacy of products available to Brazilian consumers.  📝 To understand all the changes and their implications, you can access the full text of Regulatory Instruction RDC 283/24:  It is crucial that companies and professionals in the sector are aware of these updates and adapt to the new requirements. Compliance with technical standards is essential to ensure the approval of registration, notification, revalidation, or equipment change requests.  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 

Resolution of the Collegiate Board (RDC) No. 39/2013, amended by RDC No. 15/2014, establishes that the granting of certification for Good Manufacturing Practices of health products (CBPF) may occur upon presentation of a valid audit report, issued by a third-party auditing organization recognized by Anvisa. ANVISA certifications via CBPF are valid for 2 years.  In contrast, the Medical Device Single Audit Program (MDSAP) was created to simplify and ensure rigorous standards of quality and compliance. Recognized by Collegiate Board Resolution (RE) No. 2,347/2015, MDSAP establishes important criteria and promotes efficiency in the auditing process. Certifications obtained through MDSAP are valid for 4 years.  Therefore, it is essential for companies to be aware of the available options and the validity periods associated with each type of certification, thus ensuring regulatory compliance and the quality of health products.  Check below the list of Auditing Organizations approved by the MDSAP Program and recognized by ANVISA along with their relevant information:   Audit Organization Resolution Resolution Link Validity of Recognition TUV Rheinland of North America, Inc. RE 2.851/2022 Link 15/08/2026 DQS Medizinprodukte GmbH RE 2.136/2023 Link 16/06/2026 GMED RE 1.7725/2023 Link 22/05/2026 SGS United Kigdom Ltd. RE 2665/2022 Link 07/04/2026 BSI Group America Inc RE 1.558/2021 Link 28/02/2025 Intertek Testing Services NA Inc. RE 1.181/2021 Link 23/02/2025 UL Medical and Regulatory Services of UL LLC RE 3448/2021 Link 25/08/2025 NCC Certificações do Brasil Ltda. RE 2909/2023 Link 25/07/2024 MedCert RE 1.329/2021 Link 19/03/2023 DEKRA Certification B.V. RE 1.054/2019 Link 06/02/2022 National Standards Authority of Ireland (NSAI) RE 1.754/2019 Link 05/09/2022 TUV USA, Inc. RE 2.654/2018 Link 04/09/2022 TUV SUD America Inc. RE 324/2017 Link 31/12/2020 It is crucial for companies to be aware of these Auditing Organizations recognized by ANVISA and to comply with the standards established by MDSAP. Ensuring the quality and safety of health products is a priority, and relying on recognized auditors is an essential step in this process.  Looking for guidance on how to comply with the requirements of RDC 850/2024? Contact us today.  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