MDSAP – Find Out Now: How to Double the Validity of Your BGMP Certificate and Which Auditing Organizations Are Approved by ANVISA! 

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 OrganizationResolutionResolution Link Validity of Recognition
TUV Rheinland of North America, Inc.RE 2.851/2022Link15/08/2026
DQS Medizinprodukte GmbHRE 2.136/2023Link16/06/2026
GMEDRE 1.7725/2023Link22/05/2026
SGS United Kigdom Ltd.RE 2665/2022Link07/04/2026
BSI Group America IncRE 1.558/2021Link28/02/2025
Intertek Testing Services NA Inc.RE 1.181/2021Link23/02/2025
UL Medical and Regulatory Services of UL LLCRE 3448/2021Link25/08/2025
NCC Certificações do Brasil Ltda.RE 2909/2023Link25/07/2024
MedCertRE 1.329/2021Link19/03/2023
DEKRA Certification B.V.RE 1.054/2019Link06/02/2022
National Standards Authority of Ireland (NSAI)RE 1.754/2019Link05/09/2022
TUV USA, Inc.RE 2.654/2018Link04/09/2022
TUV SUD America Inc.RE 324/2017Link31/12/2020

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 

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