The Medical Devices Introductory Course 2020

What is a Medical Device? Definition

Paragraph 13, Annex I (Definitions) of Resolution RDC No. 185 of October 22 nd , 2001, provides the following definition for a medical device in Brazil:

“Medical product: Health product, such as equipment, apparatus, material, device, or system destined for medical, dental or laboratory use or application, for prevention, diagnosis, treatment, rehabilitation or contraception, which does not utilize pharmacological, immunological or metabolic means to fulfill its main function on human beings, but however may have its functions enhanced by the use of such means.”

The Organisation for Professionals in Regulatory Affairs

What is NOT a medical device?

• According to Brazilian law (Law no: 5,991 of December 17 th , 1973), medicines (or “medical drugs”) are defined as being (pharmaceutical) products obtained or enhanced technically, with prophylactic, curative, palliative, or diagnostic purposes

Medical drugs fall into the following categories: • “New” drugs (innovative and others) • Synthetic and semi-synthetic drugs • Biologicals • Herbal drugs • Generic drugs • Similar drugs

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• Medical Devices are regulated separately from the above medical drugs

• Medical device legislation includes a specified list of products that are not considered to be medical devices, including (not exhaustive): • General laboratory equipment • General hospital support products • Physical training and sports products “RELAÇÃO DE PRODUTOS NÃO CONSIDERADOS PRODUTOS PARA SAÚDE (Lista Exemplificativa - versão 2.0, abril/2014)”

The Organisation for Professionals in Regulatory Affairs