ANVISA RDC 59
ISO 13485 (ISO 14971)
FDA 21 CFR 820
Preparation for ANVISA inspections

Administrative rules:

ANVISA SVS/MS 686

EU Directives (CE Mark):

MDD 93/42/EEC
IVDD 98/79/EC

Medical device product registration in Brazil, USA, European Union and Australia

A medical device is generally considered to be “a product for human health, such as equipment, devices, materials, articles or systems that possess a medical, odontological ou laboratory use or application, intended for the prevention, diagnosis, treatment of disease or rehabilitation or contraception and that does not acheive its principal intended action via pharmacological, immunological or metabolic means, but which may be supported in its function by such means.”

If your organization manufactures or stores and distributes medical devices and isn’t in accordance with the required local or international legislation, enter in contact with our customer service center, or write to atendimento@ambientequalidade.com.br, and ask for a proposal to attend your business needs. We will treat your information with the utmost confidentiality.

Remember that since May 2010, the manufacturers of some classes of medical devices that are exported to Brazil must meet the Brazilian GMP requirements (RDC 59) and undergo an inspection by ANVISA inspectors prior to product registration, or registration renewal. If you require assistance in meeting the Brazilian requirements for medical devices please enter in contact with us.

Policy of Confidentiality: “We, at A&Q, protect all received and exchanged information in any commercial communication, independent of the person, the means or the stage of work, as a means of guaranteeing compliance with our code of ethics and professional conduct and to protect the interests and the property rights of our clients and future clients.”