Introduction:
Relevant Laws & Regulations:
- (RDC) 348/2020, which established extraordinary and temporary rules to speed up the evaluation of new products, by prioritizing the analysis of test registration requests for detection of the new coronavirus.
- Law 13,979 / 2020, exceptionally and temporarily authorized the import of products subject to health surveillance, as long as these are registered by a foreign health authority and are provided for in an act of the Ministry of Health (VIII, art. 3).
- Good Manufacturing Practices established by RDC 16/2013. [Relevant to registration requirements of IVD.]
What are ‘Rapid Tests’?
Anvisa defines a rapid test as easy to perform and do not require other support equipment (such as those used in laboratories), and can give results between 10 and 30 minutes.
Rapid tests for antibodies (IgM/IgG) can assist in mapping the “immunized” population (which have either already had the virus or has been exposed to it), but have NO diagnostic function.
When are Rapid Tests indicated?
As antibody production increases every day from the onset of virus infection, there must be a minimum amount of antibodies that the test can detect. Therefore, the rapid test is indicated from at least 8 days after the onset of symptoms.
The use of rapid tests before this period can lead to negative results even for people who have the virus and have produced antibodies, so-called “false negative” results.
How are Rapid Test Classified by anvisa?
Rapid Tests are In Vitro Device (IVD) classified as a High Risk ( Class III) .
Anvisa Registration Requirements:
GMP Requirements:
Companies that manufacture them must meet the criteria of Good Manufacturing Practices established by RDC 16/2013. Anvisa certifies the manufacturing units that meet the requirements indicated in this resolution, related to the quality system of the companies and to the controls applied in the development and manufacture of the products.
Product Performance Evaluation:
Product Evaluation information must be provided to Anvisa. This information enables the evaluation of the reliability of the results and the diagnostic effectiveness of the product. Manufacturers need to demonstrate how the performance tests were performed and the qualification of the samples used, in addition to clinical evidence, in view of the type of product, indication of use and methodology.
Labeling and Instructions:
Labeling and instructions for use are checked to ensure that they contain the information essential for its safe use and to provide guidance to the health care professional on the procedures for performing the test, the type of sample, interpretation of results, limitations and warnings, among other relevant information.
Local Representation:
In Brazil, the registration of imported products must be made by a national company that has the manufacturer’s authorization to represent it in the country. This documentation is also part of the evaluation process.
Who Evaluates the Rapid Tests in Brazil?
The National Institute of Quality Control in Health (INCQS/Fiocruz) and the Ministry of Health have been evaluating the products.
Who can market the rapid tests for Covid-19?
The tests for Covid-19 registered by Anvisa can only be supplied through authorized legal health product distributors . In this way, the companies that can provide these tests are those that operate in the field of activity that includes the “wholesale trade of products for health”, and must have a Company Operating Permit (AFE) and a health license that includes the activity of distribution of products for health.
Can health product distributors market tests for Covid-19 to any establishment?
The tests can be marketed to legal entities whose activities are intended to provide health services to the population, such as laboratories, hospitals and other health establishments, public or private. Because these products are only authorized for professional use, their trade is not allowed to the general population.
About Global Regulatory Partners:
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.. To learn more, please contact us at info@globalregulatorypartners.com
More Resources:
- GRP Video. Medical Device Registration in Brazil.