June 12, 2025
The Ministry of Labor and Employment in Brazil, through Ordinance No. 672 of November 8, 2021 – Annex D, published the update and consolidation of the Conformity Assessment requirements for surgical and non-surgical procedure gloves, under health surveillance.
To keep our customers and partners always well informed, we highlight in this article the main differences and changes that impact certification.
Scope: Ordinance MTP No. 672/2021 expanded the certification requirements for surgical and non-surgical procedure gloves, subject to health surveillance. In addition to natural rubber gloves and natural and synthetic rubber blend gloves, synthetic rubber gloves and polyvinyl chloride gloves are now also included, which must follow the criteria established by the ordinance to ensure their compliance and safety.
Standards: In addition to the ABNT NBR ISO 10282, ABNT NBR ISO 11193 and NR 6 standards already considered by INMETRO Ordinance 485/2021, MTP Ordinance No. 672/2021 included the ABNT NBR ISO 37 and ASTM D3577, ASTM D3578, ASTM D5250, ASTM D6319 and ASTM D6977 standards in its evaluation criteria.
Initial Certification: In MTP Ordinance No. 672/2021, the provisional certificate was abolished, making only the issuance of the final certificate mandatory. Thus, the Certificate of Approval (CA) is no longer a requirement for initial certification.
Audit: According to MTP Ordinance No. 672/2021, the QMS audit must be carried out based on ISO 9001 or ABNT NBR ISO 9001.
INMETRO: The INMETRO seal and the Prodcert system cease to exist in the certification process in accordance with MTP Ordinance No. 672/2021.
Deadline for implementation of the program and adaptation
MTP Ordinance No. 672/2021 came into force on December 1, 2023, and already certified products will be analyzed for compliance with the new requirements in the next evaluation stage, whether in maintenance or recertification.
In the case of Certificates of Approval (CA) already issued for scopes that were not previously covered, the transition to the new regime must occur upon validity of the CA, or at the time of its alteration or correction.
How to adapt your products
UL Solutions offers a complete solution to ensure that all manufacturers, importers and suppliers comply with the program, in addition to providing all the support necessary for the applicant to obtain certification from the Ministry of Labor and Employment.
Do you have any questions?
Contact our sales team at healthsciencesla@ul.com.
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