Main comparative criteria for defining an equivalent

The concepts of similarity and equivalence are distinct, but these terms still generate confusion when choosing the product to be used as a comparator in a clinical evaluation. It can be said that a similar product is one that will be used for the same purpose, but will not necessarily have the same technical characteristics.

For a product to be equivalent to another, it will need to have, in addition to the same intended uses, the same technical and biological characteristics. More details on these aspects below:

According to ANVISA Guide No. 31 of 2019 (Guide for Clinical Evaluation of Medical Devices), the main criteria to be considered to determine if a device is equivalent to others are divided into three main parts:

? Intended use or indication for use: indications for use, including the disease or condition that the medical device will diagnose, treat, prevent, cure or mitigate; the severity and stage of the disease; patient population (e.g., age, sex, anatomy, physiology); site of application in the body (organs, body parts, tissues or body fluids that come into contact with the medical device); type of contact (e.g., contact with mucous membranes, invasiveness, implantation); duration of use or contact; environment of use (e.g., healthcare facility, home); intended user (e.g., use by healthcare professional, lay person); repeated applications, including restrictions on the number or duration of reapplications;

? Technical criteria: device design, composition, specifications and properties (e.g., physicochemical properties among others) critical performance requirements and principles of operation;

? Biological characteristics: biocompatibility of materials in contact with body fluids and tissues; biological action; degradation mechanism and profile; biological response.

In addition, in some cases, additional tests may be necessary to establish the degree of comparability, depending on the device under evaluation, such as in clinical evaluations for hyaluronic acids, where rheology tests are performed to prove their equivalence.

 

References:

1. https://www.gov.br/anvisa/pt-br/centraisdeconteudo/publicacoes/produtos-para-a-saude/manuais/guia-de-avaliacao-clinica-de-dispositivos-medicos/view