ANVISA has published the second trimestral GGTPS (Medical Device Technology General Management) performance report. The report presents data, results and metrics concerning the first two trimesters of 2019. The first report, published ion April, can be found on ANVISA’s website.

According to Leandro Rodrigues Pereira, General Manager of the GGTPS, the performance report is a management tool that attends to the Agency’s duty and commitment on being transparent and providing useful data to society and the industry. It also serves the purpose of monitoring the medical device sector’s services demands.

Check below DOMO Salute’s team analysis on the report and GGTPS’ more important results ion 2019:

Petition balance positive in 2019

The petition balance is calculated by taking into consideration the number of petitions completed (outcomes) and the number of petitions filed (incomes) at a set period of time. It is interesting to observe that the number of petitions waiting to be analyzed and/or under analysis, during the second trimester is lower comparing to the first trimester of 2019. The balance now is positive with 10.425 being the number of petitions entering GGTPS for analysis (incomes) and 11.823 the number of petitions completed (outcomes) in 2019.

The new regulatory path for lower risk products (Notification) is certainly one of the responsible for the better results achieved. Notification is a simple registration path for Class Risk I medical device, that came into effect on May 2019, and doesn’t require technical evaluation from the Agency. The measure has clearly impact positively on the balance.

Rejection rates are lowest since 2018

Rejection rates for the second trimester were 8,2%, the lowest since the beginning of 2018. Comparing to the first trimester of the year, the rejection rate is significantly lower, especially if we look at Registro submissions (Class risk III and IV) and secondary petitions.

ANVISA believes the good results are a reflection of a series of webinars that have been available at the Agency’s website as they might have helped companies to better understand the requirements, therefore reducing rejection rates.

Timeframe averages 

Regarding the timeframe to get ANVISA’s first response (being the approval issue or additional requirements) the average for the second trimester was 31.82 days – the lowest since the beginning of 2018. Certainly the good performance is also reflecting the advent of Notification path – which takes an average of 10 to 20 days to be issued by ANVISA.

Considering only the timeframe to get ANVISA to publish the approval (not their first response) – it rises up to 74.90 days. There’s been a small increase on the timeframe to issue Cadastro (Risk Class II) and Registro’s approval comparing to last year, but 2019 numbers are still satisfactory considering ANVISA’s performance throughout the years. The average is expected to decrease during the next semester due to Notification process reducing the workload and allowing ANVISA’s evaluators to focus on Cadastro and Registro petitions.

Taking a closer look on the different divisions’ performances (GEMAT – the division responsible for materials, GQUIP – division responsible for equipment and GEVIT – division responsible for IVDs) we can see that they share the same tendencies, which demonstrates they are working consistently and towards the same goals.

The performance report also presents a few highlights from the trimester such as:

• National and International Regulatory events with ANVISA’s participation;
• Important regulatory publications such as the Notification process and the public consultation on custom made devices.

To download the second trimester performance report for 2019, check ANVISA’s website.

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DOMO Salute Team