Know the numbers of ANVISA’s post-market monitoring of products in 2021.
Last year, 216,406 notifications were received by Anvisa’s monitoring area regarding adverse events, technical complaints and deviations in product quality, as well as reports of intoxications. Of these notifications, 124,523 were divided by the agency into specific surveillance, namely pharmacovigilance, techno vigilance , …
Publication of the proposal to review the Technical Regulation for Measurement of Oil and Natural Gas (RTM) of ANP and Inmetro
The Joint Resolution ANP/INMETRO 001/2013, with a proposal to review the Technical Regulation for Measurement of Oil and Natural Gas (RTM) is now available for public consultation. The document aims to establish the requirements and conditions to be observed by the oil …
Anvisa optimizes clinical research through new regulation
On February 16, Anvisa published in the Official Journal of the Union, the Collegiate Board Resolution (RDC) 601/2022, which deals with the simplified analysis, in an exceptional and temporary way, of clinical research petitions. This Resolution aims to optimize the release of …
Uncategorized More than 3 million non-approved handsets are withdrawn from circulation by ANATEL.
The year 2021 brought a heavy blow to the piracy of telecommunications products in Brazil. Throughout the year, the National Telecommunications Agency (ANATEL) removed approximately 3.3 million of irregular equipments from the market. This number is the highest since 2018, the year …
VigiMed has now new features.
As part of the improvement in pharmacovigilance, Anvisa announces that the VigiMed system has received new functionalities. The most awaited news is the Medical Dictionary for Regulatory Activities (MedDRA), which has been incorporated into the manual data entry module. This new measure …
Inmetro announces the Regulatory Agenda for Legal Metrology for the first time
Inmetro’s Legal Metrology Board (Dimel) announced in an unprecedented way its Regulatory Agenda for the years 2022 and 2023, as stated in the Federal Official Gazette. This publication had great popular participation and designates the main topics for the period, reviewing metrological …
Anvisa updates the codes of its Contingency Plan
Recently, Anvisa announced that it identified the need to include and change the subject codes for the Import Licensing petition, through the Request System, originating from the registration of LPCO – Licenses, Permissions, Certificates and Other Documents, in the Single Foreign Trade …
Inmetro makes two patent applications internationally protected
According to a statement from Inmetro (National Institute of Metrology, Quality and Technology), two of its patents, which already had deposits in Brazil, are now also protected abroad. Potential innovations are in the area of telecommunications and biotechnology. The first concerns data …
Norm on imports of medicines and medical devices reaches the end of its validity, according to Anvisa
With the emergence of the pandemic, Brazil needed to supply itself with essential products to face Covid-19 in hospital environments. For this, the RDC 483/2021 was created as an emergency, which aimed to supply the national market in order to meet all …
Change simplifies the provision of Inmetro’s identification seals
Previously, you had to obtain an approval in advance with Inmetro. Nowadays, though, the printers were authorized to provide the seals. All you need to do is request the file with the safety specifications for the necessary purpose. These seals’ issuance …