The landscape of healthcare technology is rapidly evolving, and software as a medical device (SaMD) is at the forefront of this change. In Brazil, the regulation of SaMD is governed by ANVISA (Agência Nacional de Vigilância Sanitária) and the Resolution RDC 657/2022 brought in significant clarity and direction. This blog explores the implications of RDC 657/2022 and its role in regulating SaMD in Brazil.
Overview of ANVISA Regulation of SaMD in Brazil : RDC 657/2022
Regulations for Software as a Medical Device (SaMD) have been in place for a long time under Brazilian law, specifically Law 6360/1976. Initially, SaMD was classified according to RDC 185/2001. However, with the introduction of RDC 657/2022 on March 30, 2022, which took effect on July 1, 2022, the unique characteristics and regulatory requirements of SaMD are now specifically addressed. It is important to interpret RDC 657/2022 in conjunction with other applicable ANVISA regulations for medical devices.
Products Not Considered as Software as a Medical Device (SaMD) in Brazil
In Brazil, certain products are explicitly excluded from classification as Software as a Medical Device (SaMD). These include:
Well-being Products: Software or applications designed solely for enhancing general well-being and lifestyle do not qualify as SaMD.
Unregulated Products: Items listed by the National Health Surveillance Agency (ANVISA) as unregulated do not fall under SaMD classification.
Administrative and Financial Software: Software used exclusively for administrative management and financial operations within healthcare services is not considered SaMD.
Demographic and Epidemiological Data Processing: Software that processes demographic and epidemiological medical data without any clinical diagnostic or therapeutic intent is excluded from SaMD classification.
Additionally, software that is solely intended for data transmission does not fall under the regulations outlined in RDC 751/2022 and is not considered a medical device by the Equipment Technology Management (GQUIP/GGTPS/ANVISA).
Furthermore, applications designed for telemedicine that are limited to functions such as scheduling appointments, creating electronic medical records, recording patient status, and facilitating communication between doctors and patients via audio or video are also not classified as SaMD.
ANVISA Classification of SaMD in Brazil
The classification of Software as a Medical Device (SaMD) remains aligned with the framework outlined in RDC 751/2022, which divides software into four risk classes:
Class I
Class II
Class III
Class IV
For additional guidance on classification, ANVISA offers various channels for direct communication, including online forms and scheduled meetings.
ANVISA Registration Requirements for SaMD in Brazil
RDC 751/2022 outlines the registration procedure for higher-risk class products (Classes III and IV), detailing the necessary documentation and processes and also describes the notification procedure for lower-risk class products (Classes I and II), including their required documentation and procedures.
Class I and II: Governed by a notification regime
Class III and IV: Subject to a more rigorous registration regime
If a SaMD from any risk class (I, II, III, IV) incorporates innovative technology and lacks scientific publications demonstrating its safety and efficacy, it must seek authorization for clinical research.
Interoperability and Manufacturer Responsibility
Although ANVISA does not require extensive details about the interoperability of SaMD during the regulatory process, it is crucial for manufacturers to provide sufficient information to clearly define the validated environment of use. This clarity helps outline the manufacturer’s responsibilities, especially concerning aspects of the software that may remain unclear during the approval process.
ANVISA Pre-requisites for Registration of SaMD in Brazil
To successfully register Software as a Medical Device (SaMD) in Brazil, several pre-requisites must be fulfilled:
Manufacturers must obtain a Health License from the Municipal or State Health Surveillance Agency (Local VISA)
Manufacturers must also obtain "Autorização de Funcionamento de Empresa" (AFE) issued by ANVISA in accordance with RDC 16/2014. The AFE is a crucial requirement for all medical device manufacturers, including developers of SaMD. This authorization ensures that the manufacturer’s identity, production methods, and quality control practices comply with regulatory standards. The AFE process remains unchanged with the introduction of RDC 657/2022 and is essential for all manufacturers, including those focused on software.
Appointment of Technical and Legal Managers:
Manufacturers must appoint a Technical Manager responsible for overseeing the technical aspects of the SaMD, including compliance with safety and efficacy standards.
A Legal Manager must also be designated to ensure adherence to regulatory requirements and handle all legal matters related to the product’s registration and compliance.
Good Manufacturing Practice (GMP) Compliance:
For Class I and II SaMD, compliance with Good Manufacturing Practices (GMP) as outlined in RDC 665/2022 is required.
For Class III and IV SaMD, manufacturers must obtain a BGMP Certification to demonstrate adherence to higher manufacturing standards.
Declaration of Conformity: A declaration of conformity is required only for risk class II, III, and IV software. This document must demonstrate that the SaMD meets applicable regulatory requirements and standards.
ANVISA Regulation of Embedded Software in Brazil
It’s important to note that embedded software must be regulated alongside the hardware it operates on and cannot be treated separately. Embedded software is defined as software specifically developed for incorporation into medical devices and is not suitable for general-purpose devices such as tablets, mobilephone etc;
Software considered as SaMD but do not require Registration in Brazil
Certain SaMDs, particularly those developed in-house for internal use within healthcare services and classified as risk class I or II, do not require ANVISA registration. In these cases, the healthcare service assumes responsibility for validating the software’s performance and safety.
ANVISA Post-Approval Change Management of SaMDs in Brazil
Once a Software as a Medical Device (SaMD) is registered, any significant changes to the software must be reported to ANVISA through a change petition. This requirement applies if changes affect functionalities or clinical indications, including modifications to algorithms that introduce new functionalities or significantly impact safety, efficacy, or performance.
According to law 6360/1976, ANVISA has a response deadline of 90 days for petitions, while RDC 743/2022 establishes a 30-day deadline for notifications related to risk classes I and II. However, initial responses can be expected in less than 30 days
ANVISA Labeling Requirements for SaMDs in Brazil
The labeling for Software as a Medical Device (SaMD) is crucial for ensuring that users have access to essential information about the product. This section outlines the key requirements for labeling, emphasizing visibility and compliance with regulatory standards.
Labeling Placement:
Product Packaging: The label must be affixed to the physical packaging of the software. This applies to all physical distributions, including but not limited to USB drives, CDs, and other storage media.
Software Interface: When the software is distributed digitally, the label must be prominently displayed on the software itself. The preferred location for this label is the opening screen or a dedicated tab that provides essential information about the software.
Visibility: Labels cannot be restricted to the instructions for use (IFU), which should be accessible via a clearly identified tab (e.g., "Instructions for Use" or "Help"). The label must be easily visible to users before they access the IFU, ensuring that critical information is readily available.
Regulatory Compliance: In accordance with ANVISA's resolution RDC No. 431, dated October 13, 2020, all SaMD must have their instructions for use uploaded to ANVISA’s electronic portal. This requirement does not absolve manufacturers from including the instructions within the software or providing them in printed form as per RDC 657/2022.
The label and instructions for using the software can be made available within the software itself, ensuring easy access. In the case of virtual distribution, the company is not obligated to provide physical labels. Nonetheless, the information must contain identification of the product and its version for traceability according to good manufacturing practices, rather than depending on batch or serial numbers. The information on the SaMD label or IFU must on a mandatory basis include below information-
Procedures for updating SaMD;
Minimum hardware and software requirements;
Operating principles, including general descriptions of the algorithms, routines, and formulas used for clinical processing (such as prevention, diagnosis, treatment, rehabilitation, or contraception) along with their valid clinical associations;
Alerts and warnings;
Specifications for interoperability, including indications of compatibilities and any incompatibilities related to software, hardware, and technological environments
Information on cybersecurity.
ANVISA Documentation Requirements for Class I and Class II SaMDs in Brazil
To notify ANVISA for Class I and Class II SaMDs, the following documentation is required:
Notification Form for Class I and II
Authorization Letter from the Manufacturer: Must be apostilled or consularized if the SaMD is imported.
INMETRO Electromedical Certificate: Required if the SaMD includes any electromedical accessories covered by electromedical certification standards.
Documentation Demonstrating Safety and Efficacy: In accordance with RDC 546/2021, required if the product is innovative. If clinical studies are needed in Brazil, a study plan must be submitted to ANVISA for approval in advance, per RDC 548/2021.
ANVISA Documentation Requirements for Class III and Class IV SaMDs in Brazil
For the registration of Class III and Class IV Software as a Medical Device (SaMD), the following documentation is required:
Registration Form: Applicable to Classes III and IV.
Labeling: Must comply with the requirements specified in RDC 751/2022 and RDC 657/2022.
Instructions for Use: As detailed in 751/2022 and RDC 657/2022.
Technical Report: In addition to the information required for other medical devices, this report must include:
Software architecture;
Hardware architecture, along with minimum and recommended technical specifications;
The platform
Compatibility, interoperability, and communication with other medical products, including software or in vitro diagnostic products;
Cybersecurity architecture and controls;
Verification and validation processes;
Risk management strategies;
Residual anomalies identified and mitigation strategies;
Clinical evaluation and valid clinical associations, including a description of the algorithms and/or routines used for processing suggestions related to prevention, diagnosis, treatment, physiological monitoring, rehabilitation, or contraception, along with their clinical or scientific basis;
Declaration of conformity with international standards or their national equivalents.
Authorization Letter from the Manufacturer: Must be apostilled or consularized if the SaMD is imported.
Certificate of Free Commercialization: Issued in the country of origin and must be apostilled or consularized if the SaMD is imported.
INMETRO Electromedical Certificate: Required if the SaMD includes any electromedical accessories covered by electromedical certification standards.
Documentation Proving Safety and Efficacy: Must comply with RDC 546/2021 if the product is innovative. If clinical studies are necessary in Brazil, a study plan must be submitted to ANVISA for approval in advance, per RDC 548/2021.
The regulatory landscape for Software as a Medical Device in Brazil is evolving, with RDC 657/2022 providing clearer guidelines for developers and manufacturers. Understanding the classification process, the significance of AFE, and the requirements for labeling and documentation is vital for navigating this complex environment. By staying informed and proactive, stakeholders can successfully bring innovative SaMD solutions to market while ensuring compliance with ANVISA regulations.
For further assistance, developers are encouraged to utilize ANVISA’s communication channels to clarify any doubts and ensure their products meet regulatory standards.
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