ANMAT is a decentralized body, dependent on the Ministry of Health, which is in charge of registering, controlling, auditing and monitoring drugs, cosmetics, diagnostic reagents, medical devices, elaborated foods, dietary supplements, additives, sweeteners and ingredients; home-use products, disinfectants and insect repellents; oral hygiene products for dental use.

A medical device is a health product, such as equipment, apparatus, material, item or contrivance or medical, dental or laboratory application meant for prevention, diagnosis, treatment, rehabilitation or contraception, which does not use a pharmacological, immunological or metabolic means to fulfill its main purpose in human beings. However, it may be helped by such means to fulfill its purposes.

All medical devices registered with ANMAT must carry a label which includes the registration number of the medical device expressed in this way: “Authorized by ANMAT – PM (Company´s file number) – (Number of medical device registered by the company)

The registration of a medical device is valid for 5 years. It may be validated over and over again for the same period of time.

Those companies authorized by ANMAT, whose products are registered with ANMAT and who hold a valid Certificate of Good Manufacturing Practices (BPF) issued by ANMAT may sell medical devices. It is worth mentioning the authorization and its term of validity is determined by the BPF Certificate and not by the Authorization Certificate. In case of medical device distributors who sell such devices in the provinces, they must have an interjurisdictional transit permit issued by ANMAT.

Stability studies determine a device life cycle under certain storage conditions.

Biocompatibility is the ability a biomaterial has to generate an acceptable biological response in a specific application. The fact that the organism does not reject the medical device entails a biological acceptance, as well as chemical and mechanical. The international standard that regulates this important property is ISO 10993, which sets the tests to be carried out according to the type of biomaterial and to how long it will be in contact with tissues of a living organism.

The in vitro cytotoxicity test determines if a device or component will have toxic effects on tissue cells.

The acute systemic toxicity test provides general information about the physiological risks that may arise from acute exposure of a medical device or chemical material.

This test is used to determine a device ability to trigger sensitizing activity (hypersensitivity) where cellular and humoral immune mechanisms are involved, induced by a substance capable of affecting the immune system in a different way (cellular hypersensitivity). Sensitization occurs after one or several exposures.

This test is designed to determine the hemolytic properties (destruction of red blood cells) of a medical device or of its components.

The tensile strength test is designed to determine the maximum stress a body can withstand before breaking. It is synonymous of breaking load.

The sterility test is performed to verify that sterilized devices or devices prepared under aseptic conditions are free of microorganism contamination. The absence of microbe contamination revealed in this procedure confirms the device fulfills the test´s requirements. However, this is not enough to assume the whole tested batch has been sterilized, due to the limitations inherent to the sample´s statistics. A sterile condition is assured through the sterilization or the aseptic validation process.

The surgical gauze we manufacture brings in its pouch an indicator that changes colour when the product is subject to sterilization. The colour of the indicator is shown in the container as proof of sterilization.

The radiopaque thread in surgical gauze is not intended to be applied directly on patients, but to be x-ray or CT-scan detectable.