Anvisa begins economic monitoring of medical devices

​On March 12, 2021, the Collegiate Executive Board of the Brazilian Health Regulatory Agency (Anvisa) approved new rules to implement a medical device monitoring system through Collegiate Board Resolution (RDC ANVISA 478/2021), ANVISA Normative Instruction No. 84/2021 (IN ANVISA 84/2021), and ANVISA Normative Instruction No. 85/2021 (IN ANVISA 85/2021).

Anvisa’s legal attribution supports the measure to monitor medical equipment devices’ price evolution under Law No. 9782 of January 26, 1999 (Law No. 9782/99). However, so far, the Agency has no jurisdiction to act in economical price regulation.

The approval of the Collegiate Board Resolution (RDC) and Normative Instructions (IN) is the result of a Regulatory Impact Analysis that revised ANVISA RDC 185/2001, which counted with a Public Discussion (TPS) and an Interinstitutional Workgroup on Prostheses, Orthotics, and Special materials (GTI-OPME) formed by governmental and representative entities. In addition, the topic was the object of three Public Consultations held between August and October 2020 – CP 876/2020, CP 877/2020, CP 878/2020, respectively. According to the Public Consultation Report, about 60% of the RDC draft suggestions (CP 876/2020) were incorporated.

The monitoring measure will be implemented on a gradual and incremental basis. As for the most relevant aspects of the new regulatory framework, it is worth highlighting:

• The economic monitoring of medical devices is defined as the continuous monitoring of the medical equipment prices, as well as other economic data that are relevant to reduce information asymmetry in the market;

• It is up to the registration holder to submit to Anvisa the information on technical qualities of each medical device model subject to economic monitoring – the Agency may also request economic information about the product;

• For new medical devices, the submission of information should be within 60 days after the publication of registration. For products already registered, the submission is upon Anvisa’s request and the post-registration applications that include new models, alter or include information regarding technical qualities (in this case, within 60 days after the granting of the post-registration change);

• RDC ANVISA 478/2021 must be reviewed three years from its effective date, based on the economic monitoring results determined through the Monitoring and Evaluation of Regulatory Result (M&ARR).

Economic Monitoring System

Anvisa considers the following criteria for the selection of medical devices subject to economic monitoring:

• Financial Impact for Brazilian’s National Healthcare Program (“SUS”), considering, at least, the percentage represented by the medical device in the total spending on public procurement, according to information the Ministry of Health obtains;

• Financial impact for the supplementary health system; and

• Verified relevance to public healthcare.

Anvisa gathers the historical market prices, so the economic monitoring results are disclosed on a website, allowing the consultation of prices by grouping medical devices and equipment with similar technical characteristics and according to pre-defined features. This information may help to define price benchmarks for public or private procurement of medical devices. Anvisa should update the results every quarter, adopting measures to avoid identifying individual product prices and safeguarding other sensitive commercial information.

Covered products

The approved INs establish a selection of 13 medical devices for initial monitoring (ANVISA IN 84/2021) and their respective technical qualities (IN ANVISA 85/2021). These are destined for cardiological use as listed below:

• Dual-chamber implantable defibrillator

• Single-chamber implantable defibrillator

• Implantable defibrillator for cardiac resynchronization therapy

• Biological heart-valve prosthesis

• Mechanical heart valve prosthesis

• Drug-eluting stent for coronary arteries

• Stent for coronary arteries

• Implantable dual-chamber cardiac pacemaker with a frequency response

• Implantable dual-chamber cardiac pacemaker to sensor metabolic demand

• Implantable single-chamber cardiac pacemaker of same pacing frequency and metabolic demand

• Implantable single-chamber cardiac pacemaker with a frequency response

• Implantable pacemaker for cardiac resynchronization therapy

• Intracardiac pacemaker

It is worth remembering that the newly approved regulations meet a determination of the Federal Court of Accounts (TCU), which specified the need for measures to establish a price benchmark that could serve for public procurement, as well as for monitoring and disclosure of economic information – under the terms of TCU Judgment 435/2016.

For more information about medical devices, contact Mattos Filho’s Life Sciences and Healthcare practice area.

*With the cooperation of Camila Miranda Amaral.