Resolution of the Collegiate Board of Directors-RDC No. 665, of March 30, 2022, consolidates the technical regulation of Good Manufacturing Practices and Distribution and Storage of medical products and products for in vitro diagnosis, contemplated until then in the Resolution of the Collegiate Board of Directors- RDC No. 16, of March 28, 2013, and Normative Instruction-IN No. 8, of December 26, 2013.
This Resolution applies to manufacturers, distributors, stockers and importers of medical products and in vitro diagnostic products that are marketed in Brazil.
According to RDC No. 185, of October 22, 2001, determines the following definitions:
Medical product: Health product, such as equipment, device, material, article or system for medical, dental or laboratory use or application, intended for prevention, diagnosis, treatment, rehabilitation or contraception and that does not use pharmacological, immunological or metabolic means to perform its main function in human beings, being able, however, to be assisted in its functions by such means.
The first major highlight of RDC 665 is the continuous improvements that are encouraged to be implemented.
The issue of quality is highly evident in the standard, which asks manufacturers to establish specific people to carry out the quality check. In addition, RDC 665 also advocates greater rigor in document management, in order to ensure that all processes required in the standard are correctly complied with.
RDC 665 also applies for distribution and import, which means that quality standards, training and management involvement need to be considered in the case of distributors and importers.