The Brazilian Health Regulatory Agency – ANVISA – released on March 5^th the report Regulation in Numbers, presenting the 2020 actions aiming to improve the regulatory quality of the Agency. The report summarizes the main activities of the year, such as general and normative publications, regulatory projects, community participation events and innovations implemented.

The Report shows that 161 regulatory instruments were published in 2020, covering Collegiate Board Resolutions (RDC), Normative Instructions (IN), Joint Normative Instructions (INC) and Guides. Regulations on drugs and medical devices were prevalent among those related to products subject to health regulation.

Due to the Covid-19 pandemic, there was an increase of 39.2% on regulations published by ANVISA. A total of 53 normative acts and 2 Guides were issued regarding the access to essential products and services in the fight against the new coronavirus.

ANVISA has also released a set of 106 proposals for Regulatory Projects that will compose the 2021-2023 Regulatory Agenda, which is expected to be published in April. There are 11 regulatory projects for the medical devices’ field:

• Implementation of the National Implant Registry (RNI) in Brazilian’s public and private health services
• Unique Device Identification (UDI) for medical devices
• Revision of the medical devices clinical trials’ normative (Resolution RDC No. 10/2015)
• Creation of a normative to increase the access to medical devices
• Updates on the Normative of Blood Bags Good Manufacturing Practices
• Reprocessing of Reusable Medical Devices
• Regulation of importation, commercialization and donation of used and refurbished medical devices
• Regulation for Software as a Medical Device
• Regularization of orthopedic implants
• Parametric release of medical devices
• Review of the Resolution RDC No. 183/2017, which provides the procedures to obtain the Brazilian Good Manufacturing Practices (BGMP) Certification for medical devices.

In addition, 140 Regulatory Process have been initiated, formalizing the start of the regulatory assessment that ends with the publication of normative by the Agency.

One of the stages of the regulatory processes is related to the Regulatory Impact Analysis (AIR). The first AIR concluded according to the new model in force is related to Economic monitoring and dissemination of medical devices’ information, wherewith ANVISA intends to face the regulatory problem of the “wide dysfunctionality of the Brazilian market for medical devices in Brazil, regarding imperfect and asymmetric information”. The subject was already assessed in Public Consultation and the new Regulatory Framework was published at Resolution RDC No. 478/2021, to enter into force on April 1^st 2021.

ANVISA also built a theoretical framework with the 1st Guideline for the implementation of the Monitoring and Evaluating Regulatory Results (M&ARR) within the scope of the Agency. The document aims to establish the bases to construct a governance and implementation model of procedures for M&ARR at ANVISA.

In order to simplify processes, ANVISA carried out the “Descarimba” Project and adapted 12 normative, exempting the authentication of copies and the signature recognition of certain documents presented to the Agency. With this measure, it is estimated that the sector will save R$ 693 thousand Brazilian reais per year.

Also in 2020, ANVISA decided about “frontier products”, which are products that weren’t clearly defined by the Agency within the regulatory framework. In this process, all artificial tears indicated exclusively for ocular lubrication had their sanitary framework defined as medical device.

In order to improve the regulatory quality of the Agency, ANVISA has 4 Strategic Goals and 5 Objectives defined in the Regulatory Quality Improvement Project. The Strategic Goals comprise the 2020-2023 ANVISA’s Strategic Plan, and includes expanding to 90% of the normative acts published as a result of its Regulatory Agenda, implementing 100% of the AIRs according to the new model in force, increasing to 24 medical devices with historical price monitoring and actions to reduce administrative costs. The Objectives of the regulatory improvement project includes the establishment of the AIR using culture, qualification of the access to the regulatory inventory, implementing the Monitoring and Evaluation of Regulatory Results and implementing the simplified model for measuring of the administrative burden.

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DOMO Salute Team