Twelve months after a substantial update of the regulatory framework for medical devices, the National Health Surveillance Agency (Anvisa) continues to prioritize the revision or drafting of rules related to this category. The goal is to modernize the Brazilian regulatory environment.

More than 20 years after the previous standard (Anvisa RDC 185/01 ), Anvisa RDC 751/22, which came into force on March 1^st this year, updated the requirements on the risk class, regularization, labeling requirements and use instructions of medical devices.

According to the new rule, medical devices (formerly called a medical product or related), are defined as any instrument, apparatus, equipment, implant, in vitro diagnostic device, software, material or other article intended for use in humans, for any of the following purposes:

The applicable framework to each product considers 22 rules that assess the risk inherent in the functionalities, purposes and mechanisms of action of each device. According to the framework, the regularization regime at Anvisa is defined: whether the request for notification or marketing authorization (MA).

Medical devices fall into two subcategories:

In vitro diagnostic medical device: reagents, calibrators, standards, controls, sample collectors, software, instruments or other articles for the in vitro analysis of  samples derived from the human body, with the aim of providing information for diagnosis (or aid), monitoring, compatibility, screening, predisposition, prognosis, prediction or determination of the physiological state. Activities involving these products is also regulated by Anvisa RDC 36/15.

• Medical software (also called Software as a Medical Device or SaMD): is the product or application intended for one or more of the purposes indicated in the medical device definition and performs its functions without being part of a hardware. Can have these possible characteristics:
  • run on a general-purpose computing platform (non-medical purpose); and
  • be used in combination (e.g. as a module) or interaction with other products.

Medical software is also subject to specific regulation – Anvisa RDC 657/22, which sets out the processes, documents and information needed to regularize these products.

More recently, Anvisa approved the first amendment in Anvisa RDC 751/22 to regulate the situations in which the importation of products with manufacturing date prior to the regularization date in Brazil would be allowed.

In addition, Anvisa's Collegiate Board recently opened a public consultation on the use of analyses carried out by an equivalent foreign regulatory authority (AREE).

Check out the details on the topic below:

• Regulatory convergence with foreign authorities

As of September 11, Anvisa will receive contributions to the Public Consultation 1,200/23, which intends to regulate the procedure for analysis and decision of petitions for medical devices registration, using the analyzes performed by AREEs.

AREEs are defined as regulatory authorities or foreign international entities recognized by Anvisa as being of regulatory reliance. Effectively, they are institutions considered capable of guaranteeing that products authorized for distribution have been properly evaluated and meet recognized quality, safety and efficacy standards.

General rules for admission of analysis performed by AREE were recently defined through Anvisa RDC 741/22.

The rules will be applicable to medical devices classified as risk classes III and IV, as well as to in vitro diagnostic medical devices (regulated by Anvisa RDC 36/15) – except when they have been authorized by AREE through an optimized analysis process.

The main points of the draft normative instruction presented in the consultation include:

• The applicant for registration must submit the following documents: specific declaration present in the normative; document proving registration or authorization issued by the foreign authority; and the product’s instructions of use, in addition to the other documents already required in the dossier.

• Only authorities in Australia, Canada, Japan and the United States are considered AREEs.

• The optimized analysis requirement does not prioritize the petition. The analysis should be maintained according to the petitions chronological order.

Anvisa's prediction is that the new rule anticipates the analysis of 1/4 of the requests that are currently in the queue.

Contributions can be made until October 25 through an electronic form that will be available on Anvisa’s website as of September 11.

• Update of the medical device regulatory framework

Anvisa RDC 810/23, approved in August and already in force, changes Anvisa RDC 751/22. The new resolution regulates the medical devices importation with a manufacture date prior to the regularization date in Brazil.

In the past, Anvisa imposed restrictions in these cases. However, considering the absence of restriction on the matter in the Imported Goods and Products Technical Regulation (Anvisa RDC 81/09), the agency began to allow products manufactured before obtaining the MA or notification to be placed on the Brazilian market, provided that they comply with the following requirements:

• a period of five years between the manufacture and regularization dates;
• compliance with the characteristics of its sanitary regularization; and
• presentation of a declaratory document issued by the notification or MA holder, attesting the compliance with the two requirements above-mentioned, as well as attesting that the product was manufactured according to the good manufacturing practices for medical devices.

• Cybersecurity will be subject to specific regulation

At the end of 2022, Anvisa held Public Consultation 1.112/22 to discuss the essential safety and performance requirements applicable to medical devices, including in vitro diagnostic  (IVD).

Now, the agency is analyzing the contributions received and should issue an updated text until the end of the regulatory agenda.

The future standard is expected to update the requirements set forth in Anvisa RDC 56/01  – recently replaced by Anvisa RDC 546/21 during the "Review" process.

It is likely that the standard also aligns with the principles and elements adopted internationally, such as: requirements related to clinical evaluation, sterilization and contamination, the environment and conditions of use, chemical, physical and biological properties, labeling, among others that are necessary to ensure the safety and effectiveness of new technologies in the regulated market.

• Upcoming discussions

Anvisa's current 2021-2023 Regulatory Agenda foresees the discussion of other relevant topics regarding the medical device industry, including:

• review of the regulation on clinical trials with medical devices (Anvisa RDC 548/21);
• preparation of a new Documentation Specification Guide for the Medical Devices Electronic Petitioning; and
• updating the standard on in vitro diagnosis medical devices (current Anvisa RDC 36/15).

The Life Sciences & Healthcare practice can provide more information about products regulated by Anvisa.