The INCQS (National Institute for Quality Control in Health) is an entity linked to the Oswaldo Cruz Foundation (Fiocruz) in Brazil, dedicated to quality control in health-related products and services. The institute conducts analyses, tests, and certifications to ensure the quality and safety of products regulated by the National Health Surveillance System, which is part of the Unified Health System (SUS), such as medicines, health products, food, diagnostic kits, dialysis articles and supplies, cosmetics, among others.
The Institute carries out its responsibilities by conducting laboratory analyses of products subject to health surveillance; establishing new quality control methodologies; promoting regulatory actions in partnership with Health Surveillance; training professionals and providing technical assistance to the quality control laboratory network. These competencies are provided for in Article 28 of Decree No. 4,725, dated 06/09/2003, which approves the Statute of the Oswaldo Cruz Foundation – FIOCRUZ.
The analyses carried out at the Institute (chemical, physical, physicochemical, toxicological, immunological, pharmacological, microbiological) can be classified as regulatory, preliminary, control, guidance, and special analyses.
- Fiscal Analyses: Carried out on products submitted to the National Health Surveillance System as a routine procedure, aimed at investigating infractions or verifying deviations regarding the quality, safety, and efficacy of products or raw materials.
- Preliminary Analyses: Conducted on specific products under health surveillance regulations, in order to determine if they are eligible for sanitary registration by the National Regulatory Authority.
- Guidance Analyses: Performed to monitor certain characteristics or conditions of products under health surveillance regulations. These analyses generally support government monitoring programs.
- Control Analyses: Carried out on products under health surveillance regulations after they have been introduced to the market, with the purpose of verifying the product’s compliance with the characteristics provided during sanitary registration. The product is received at the Sample Reception Center (CRA) and sent to the laboratories where the analyses are conducted.
At the conclusion of laboratory analysis for any product and for any of the aforementioned modalities, a report is issued and sent to the requester.
Among the conformity certificates mentioned in other articles, such as INMETRO and ANATEL, the INCQS certificate differs in that it does not need to be submitted as a prerequisite for product notifications or registrations in the healthcare sector. This certificate is required by ANVISA during the submission analysis, where the type of analysis to be performed is indicated, along with the necessary steps.
