In tackling the Covid-19 pandemic ANVISA has been focusing on the transparency of data, and recently made available for consultation, through Business Intelligence (BI) platforms, the results from monitoring Covid-19 related products and diagnostic tests.

One of the platforms is the Post-Market Monitoring of the quality of Covid-19 related devices subject to health surveillance, which provides data on products that are or have been in an irregular situation.

The issues might be related to unsatisfactory performance on tested products, lack of Good Manufacturing Practices Certification (CBPF) or of the local ANVISA Operating Permit  (AFE), absence of registration, irregular labelling, amongst others.

The panel shows products divided into categories (medical devices, IVD, sanitizers and cosmetics), and brings informations such as the name of the company, product and actions taken.

Anvisa clarifies that, if the company complies with the rules and solves the problem detected, the measures can be revoked. For this reason, the panel also has information on the status of the product and a link to the publication of the measure adopted.

According to data available on the platform until August 26, most of the products targeted by restrictive measures were cosmetics (43.27%), such as hand sanitizers. Next are sanitizers (33.65%), IVD (17.31%) and other medical devices (5.77%).

There is also another panel solely with data from the Post-market Monitoring of the quality of Covid-19 IVDs achieved through laboratory analyzes. The data comes from a partnership established between ANVISA and the National Institute for Quality Control in Health (INCQS).

The goal is to assess, through laboratory tests, the accuracy and precision of  IVDs being marketed in the country, in order to guarantee the safety and effectiveness of diagnostic tests.

After ANVISA and the INCQS’ evaluation the following measures can be adopted: precautionary interdiction (preventive action); suspension of manufacture, commercialization, distribution, import and use; apprehension, destruction and withdrawal.

The panel provides organized data on the number of analyzes performed, results obtained and precautionary measures adopted. There is also a table with the commercial name of the device, the manufacturer’s identification, the number of the analyzed batch(s), the type of the report and its date of issue.

Of the 216 samples analyzed until August 26, 134 products were in compliance with the expected performance. Another 82 did not perform according to what was claimed by the supplier, being classified as “non-compliant”.

Routinely, the analytical data obtained from monitoring diagnostic tests and the measures adopted by ANVISA are updated on the public Analytical Panel. The list of regularized products is also updated daily.

According to the current rules, previous laboratory tests are not carried out by ANVISA or the INCQS before the Registration is granted. The Holder is responsible for the information provided and the production control must follow the precepts of Good Manufacturing Practices (BGMP).

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DOMO Salute Team