Phytosanitary treatments for quarantine purposes are regulated by Mapa
On August 27, the Ministry of Agriculture, Livestock and Supply (Mapa) published Ordinance No. 385, in the Official Gazette of the Federal Government, establishing the criteria and procedures for performing phytosanitary treatments with quarantine purposes. This measure is intended to meet the …
Managerial procedures required to obtain the Good Manufacture, Distribution, and Storage Practice Certificate
Anvisa issued the Resolution of the Collegiate Board of Directors (RDC) 497/2021, in which it establishes the managerial procedures required to obtain the Good Manufacture Practice Certificate and the Good Distribution and/or Storage Practice Certificate. The objective of this resolution is to …
How to add health product use instructions in Anvisa’s portal?
Anvisa requires the attachment of health product information during their registration in the regulating body’s portal. After the effectuation of the RDC no 431/2020, which enforces the upload of use instructions on Anvisa’s digital portal related to medical device notification or registration …
Anvisa’s Guidelines on Ultraviolet Light-Emitting Equipment
Anvisa issues a new technical note on ultraviolet light-emitting equipment, with clarifications and proof methodologies regarding its disinfectant effectiveness and the risks it may represent to human health. Get to know Anvisa’s guidelines, warnings and clarifications on the use of ultraviolet (UV) …
Which are the products that do not need to be regulated at Anvisa?
Did you know that some products do not need to be regulated at Anvisa? In our consultancy, we come across many customers who have this question, and in this blog post, you will understand better about the regulation of products and which …
Sale of Products for the Treatment of COVID-19 unregistered with ANVISA
The resolution RDC 483/21 extraordinarily and temporarily provides the requirements for the importation of health products and drugs identified as a priority for use in health services, due to the health urgency during the pandemic. According to the regulation of products and …
How to register needles with Anvisa?
Needles are health products employed by professionals to give injections, medications, vaccines, and to draw blood. They can be handled intravenously or intramuscularly. To make sure that the health professionals will be able to perform procedures that involve the use of needles …
How to register sanitizing products at Anvisa?
Sanitizing products are employed for sanitation, and they must be regulated at Anvisa according to the characteristics of each product and the requirements of Anvisa for them to be commercialized. In this blog post, you´ll find out how to register sanitizing products …
How to register hyaluronic acid with Anvisa?
Do you know how to register the hyaluronic acid with Anvisa? Hyaluronic acid is a pretty common substance, used in the aging fight. On this blog, you will learn more about how hyaluronic acid is registered with Anvisa. What is hyaluronic …
How can I know if a product needs to be registered with Anvisa?
Companies that manufacture and import food, pharmaceutical, correlate, sanitizing, and cosmetic products must register them with Anvisa. In other words, these products must be duly regulated to be commercialized. Read below how to find out if a product needs to be registered …