List of Products That Require INMETRO Certification

ObjectProduct ListCompliance Assessment MechanismRegulatory BodyType of OrdinanceInmetro Ordinance
Sterile Hypodermic Needles for Single Use and Sterile Gingival Needles for Single UseSterile hypodermic needle for single use, Sterile gingival needle for single useCertificationAnvisaPACOrdinance No. 84 of 10/02/2021
PacifiersPacifierCertificationAnvisaPACOrdinance No. 301 of 12/07/2021
Equipment under Sanitary Surveillance RegimeEquipment under sanitary surveillance regime, including its parts and accessories, for medical, dental, laboratory, or physiotherapeutic purposes, used directly or indirectly for diagnosis, treatment, rehabilitation, and monitoring of humansCertificationAnvisaPACOrdinance No. 384 of 18/12/2020
Single-Use Transfusion Equipment, Gravitational Infusion Equipment, and Infusion Equipment for Use with Infusion PumpTransfusion equipment, Gravitational equipment, Equipment for use with infusion pumpCertificationAnvisaPACOrdinance No. 461 of 18/11/2021
Breast ImplantsBreast implantsCertificationAnvisaPACOrdinance No. 5 of 11/01/2022
Surgical and Non-Surgical Procedure Gloves under Sanitary Surveillance Regime, Made of Natural Rubber, and Mixtures of Natural and Synthetic RubberSurgical gloves made of natural rubber, synthetic rubber, and mixtures of synthetic rubbers; non-surgical procedure gloves made of natural rubber, synthetic rubber, and mixtures of synthetic rubbersCertificationAnvisa and MTPPACOrdinance No. 485 of 08/12/2021
Baby Bottles and Bottle NipplesBaby bottles, Bottle nipplesCertificationAnvisaPACOrdinance No. 216 of 06/05/2021

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