ANVISA publishes 2018 management results

Brazilian medical device market regulator ANVISA recently published the annual Management Report concerning 2018’s results. According to Willian Dib, ANVISA’s CEO, presenting the annual report to the society reaffirms the Agency’s commitment and transparency.

DOMO’s Team has evaluated the report and summarized the highlights and key results achieved by the agency regarding medical device:

Almost 16 new registrations per day

The management report highlights that 5.780 new medical device were approved in 2018, composed by 1.106 Registro (products classified as Risk Class III and IV) and 4.674 Cadastro (products classified as Risk Class I* e II). The amount of products being registered in 2018 corresponds to almost 16 new medical device per day. The numbers also represent new registrations increasing 11,4% in the past 3 years (2016 to 2018).

*Before May 2019, products classified as Risk Class I had to comply with the Cadastro route. Since then, a new path has been created, and Risk Class I products are now regularized by Notification. Learn more from our post about Notification. https://domosalute.com.br/blog-1/new-regularization-for-class-i-medical-devices-notification

Brazilian Good Manufacturing Practice Certification – 513 granted to foreign manufacturers

Manufacturers of Risk Class III and IV medical devices must be in compliance with the Brazilian Good Manufacturing Practice (BGMP). During 2018, 99 on-site audits were performed abroad in order to achieve the certification. Also, 513 BGMP certification were granted to foreign manufacturers (new certification and renewals), while 13 applications were rejected.

Technovigilance

Technovigilance is designed to ensure that approved medical devices function in accordance by early detecting problems related to use, and promoting measures to eliminate or minimize the risks. Adverse incidents must be reported in case of malfunction and inadequate labeling, for example.

ANVISA received 13.227 formal complaints through the system NOTIVISA. The majority (93,7%) were related to medical device, whilst 4,7% were related to medical equipment and 1,6% to IVD products.

The majority of adverse events reported to ANVISA were also related to medical device (73,7%), and 26,3% related to medical equipment.

Regulatory stock management 

Managing the regulatory stock means organizing the current rules, monitoring their effectiveness and generating inputs for their review. The main goal is making the stock more efficient, rational, clear and understandable. ANVISA has been working towards a more effective regulatory stock management since 2014, and has achieved significant results in 2018. Check our post about ANVISA’s Regulatory Guillotine to learn more.

Economic Studies and Regulatory Intelligence

Since May 2018 a health product pricing panel is available for consultation on ANVISA’s website. The pricing panel gathers information on more than 5,000 model-products. The data is available for consultation by business name, product model, registration number, among others.

In addition to the basic information, the price to be practiced in the domestic market and prices in other countries are also available. The information is consolidated in an interactive panel provided by ANVISA on their website.

Download 2018 Management Report (Portuguese only).

Check ANVISA’s Management Report summary folder 2018 (English).

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DOMO Salute Team