Object | Product List | Compliance Assessment Mechanism | Regulatory Body | Type of Ordinance | Inmetro Ordinance |
Sterile Hypodermic Needles for Single Use and Sterile Gingival Needles for Single Use | Sterile hypodermic needle for single use, Sterile gingival needle for single use | Certification | Anvisa | PAC | Ordinance No. 84 of 10/02/2021 |
Pacifiers | Pacifier | Certification | Anvisa | PAC | Ordinance No. 301 of 12/07/2021 |
Equipment under Sanitary Surveillance Regime | Equipment 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 humans | Certification | Anvisa | PAC | Ordinance No. 384 of 18/12/2020 |
Single-Use Transfusion Equipment, Gravitational Infusion Equipment, and Infusion Equipment for Use with Infusion Pump | Transfusion equipment, Gravitational equipment, Equipment for use with infusion pump | Certification | Anvisa | PAC | Ordinance No. 461 of 18/11/2021 |
Breast Implants | Breast implants | Certification | Anvisa | PAC | Ordinance 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 Rubber | Surgical 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 rubbers | Certification | Anvisa and MTP | PAC | Ordinance No. 485 of 08/12/2021 |
Baby Bottles and Bottle Nipples | Baby bottles, Bottle nipples | Certification | Anvisa | PAC | Ordinance No. 216 of 06/05/2021 |