ANVISA has made available on their website the annual Management Report, concerning 2019’s results and the governance of the Agency. The report aims to make available to the society general data and specific information from technical departments.

The report shows that the Agency has achieved good results and an increasing number of medical devices registered, comparing to the previous year, and the lowest timeframe from the registration application to the final publication in 10 years. The good results in terms of deadlines can be attributed, in part, to the greater availability of the technical evaluation teams, since Risk Class I products started to undergo a Notification path, which does not require ANVISA’s technical evaluation. Learn more from our post about Notification.

Moreover, the report brings important data about the MDSAP program, which represented approximately 45% of the Good Manufacturing Practices certificates in foreign manufacturing plants issued by ANVISA in 2019. That suggests optimistic perspectives for the world’s regulatory convergence, a movement in which ANVISA aims to participate in a leading role.

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

21 medical devices approved per day

The Management Report highlights that in 2019 approximately 7,800 new medical devices were approved/registered  by ANVISA. The requests were distributed as follows: 200 orthopedic implants, 5,000 materials, 1,400 in vitro diagnostic devices and 1,300 equipment. The amount of new regularized products corresponded to the regularization of approximately 21 new devices per day. In addition to the large volume of approvals granted, the number also represented an important growth – increasing 35% when compared to 2018.

Brazilian Good Manufacturing Practice Certification

During 2019, 415 Good Manufacturing Practices (BGMP) application processes for medical device manufacturing plants were submitted to ANVISA through the regular procedure (in which ANVISA itself conducts technical inspection to ensure compliance with requirements), and 359 processes were requested to ANVISA via Medical Device Single Audit Program (MDSAP).

The MDSAP is a way through which medical device manufacturers can be audited once to be in compliance with the standard and regulatory requirements of the participants medical device markets. The main goal is to promote more efficient and flexible use of regulatory resources through worksharing and mutual acceptance among regulators while respecting the sovereignty of each authority.

According to ANVISA, with the increasing number of companies participating in the program, the Brazilian Agency was able to carry out a smaller number of international inspections, guaranteeing the efficient use of public money. In addition to saving resources, the MDSAP represents an increase in the sanitary safety of medical devices, since the auditing bodies inspect companies more frequently, sending annual reports to the Agency and to the other authorities participating in the program.

A total number of 462 BGMP certifications were granted by regular means (on-site inspection by ANVISA) to foreign manufacturers, while 48 had their application rejected. In addition, 374 certifications were granted through the MDSAP program, and only 2 requests were rejected. It is worth mentioning that automatic renewals granted are included in the amounts mentioned.

Deadlines and average time

The average time for the first manifestation from ANVISA in the processes during 2019 was of 36.88 days, or the lowest since 2009. The average time for the result’s publication for requests in 2019 was around 79 days, this being the second lowest average time since 2009.

Post-Market Surveillance

The surveillance of adverse events (harmful reactions to health, which occur under normal conditions of use, abuse or misuse) and technical complaints (notifications of suspected alteration or irregularity of a product or company in technical or legal aspects) in the post-use, or post-marketing, has as fundamental objective the early detection of problems related to use, aiming to trigger measures so that the risk is eliminated or minimized.

ANVISA received 15,224 technical complaints through the NOTIVISA system. The majority (92.47%) refer to materials, while 4.46% were related to medical equipment and 3.07% to IVD products.

Among the 3,286 adverse event notifications received, the majority were also related to materials (69.2%), and 30.8% to medical equipment.

It is worth noting that in numbers, the data related to post-market surveillance did not show a great variation, when compared to data collected by ANVISA in 2018.

Field Actions are carried out by manufacturers or medical device’s registration holders in order to reduce the risk of adverse events related to the use of products already on the market. Throughout 2019, 1,026 Field Action reports were received, which can be initial, monitoring and completion reports. Initial Field Action reports are evaluated and posted on ANVISA’s website in the form of Post-Market Surveillance Sanitary Alerts. In 2019, 356 alerts were released.

They are available here for public consultation.

New Regulatory Model

A new regulatory model – that aims to improve and qualify the country’s health standards has been into force since April 1st, 2019. The model, called the Regulatory Cycle and supported by Ordinance No. 1,741, has several advantages: it promotes changes in dealing with the preparation and review of regulatory acts, contributes to improving the planning and organization of regulatory processes; encourages the use of technical-scientific evidence; expands and values ​​the engagement of society.

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. During 2019, 103 standards were incorporated, while 227 were withdrawn from ANVISA’s regulatory stock. Most of these were eliminated through the action known as “Regulatory Guillotine”. Learn more about that here.

Click here to download 2019 Management Report (Portuguese only).

Click here to check ANVISA’s Management Report summary folder 2019 (Portuguese only).

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DOMO Salute Team