Anvisa Authorizes the immediate and emergency use of 24,000 units of Monkeypox diagnostic reagents, comprising two molecular kits produced by Bio-Manguinhos/Fiocruz.


Currently Brazil has eight reference laboratories for the diagnosis of Monkeypox, by molecular biology, which have shown limited capacity to meet the growing demand for testing requests.

By requesting the emergency use of the kits, the Ministry of Health intends to decentralize the diagnosis of Monkeypox to the Central Public Health Laboratory Network (Lacen) and provide a more timely diagnosis, reducing the time it takes for the results to be released to the patient.

The authorization was granted after a joint request from the Health Surveillance Secretariat of the Ministry of Health (SVS/MS) and the Bio-Manguinhos/Fiocruz Institute for exceptional authorization to use the aforementioned molecular kits, which are not registered with Anvisa.

About Emergency Authorization: Legislation

There is no commercial diagnostic test in Brazil with Anvisa approved registration. The protocols that have been used in the country for Monkeypox diagnosis have been based on proprietary methodologies developed by clinical laboratories (public or private), called in house methodologies regulated by Anvisa Resolution RDC 302/2005.

About the registration requests Anvisa remains alert and vigilant as to the regulatory and sanitary measures necessary to deal with the health emergency.

However, laboratory testing for cases under investigation is essential for the diagnosis and surveillance of this emerging infection and for access to drugs and vaccines to combat the disease.

Read more: Emegential Confrontation

Need Regulatory Affairs in Brazil or USA ? contact us!

GRP Brazil Services Brochure

GRP can act as your local Brazilian Registration Holder (BRH) and Support with your Market entry and product registration in Brazil.

GRP USA Services Brochure

GRP can act as your US Local Agent and help you with your registration of your products with the FDA.

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.

GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations. 

Follow GRP on Social Media !

Subscribe to our Blogs & Newsletter

Share This Post: