Anvisa announces public consultations on software as a medical device and other regulated products

​The Executive Board of the Brazilian Health Regulatory Agency (Anvisa) approved four proposals for public consultations relevant to the Life Sciences industry last week, seeking to update the regulations regarding software as a medical device, as well as the importation, manufacturing, and regularization of health-regulated products. The details of each proposal under discussion are described below:

Software as a Medical Device (SaMD)

Public Consultation No. 1,035 of April 8, 2021 (CP No. 1035/2021) proposes creating a specific regulation on software as a medical device (SaMD) in order to align the national regulatory framework with international practices.

Currently, software as a medical device is regulated by Resolution RDC ANVISA No. 185, of October 22, 2001 (RDC ANVISA No. 185/2001), which sets out general requirements for health products that software developers are often unable to meet.

The proposal defines SaMD as “software that meets the definition of a medical device, which may be in vitro diagnostic (IVD) or not, being intended for one or more medical indications, and which accomplishes these purposes without being part of medical device hardware.” The definitions are based on an International Medical Device Regulators Forum (IMDRF) document, available here, and may be used as a parameter for determining whether a product should be classified as SaMD.

According to the text, the new regulation will not apply to software that:

• Is used for wellness;
• Refers to products that Anvisa does not regulate;
• Is used exclusively for administrative and financial management in healthcare services;
• Processes medical, demographic and epidemiological data without any clinical, diagnostic, or therapeutic purpose;
• Is embedded in medical equipment.

Other relevant aspects of CP No. 1,035/2021 include:

• The detailing of documents and information that should be included in the technical dossier, according to the SaMD classification (Class I to IV);
• The requirement to comply with national and international parameters (IEC 62304:2006, IEC 62366-1:2015, and ISO 14971:2007);
• SaMD developed exclusively for internal use of healthcare services and classified as risk I and II will not be subject to Anvisa’s regularization, although its commercialization is prohibited. However, healthcare services should validate the SaMD developed internally within two years of the regulation’s publication.
• The establishment of specific safety and effectiveness requirements in order to ensure repeatability, reliability, and performance according to their intended use.
• Regulation resulting from Public Consultation No. 1035/2021 will take effect within 60 days after its publication.

Contributions can be made until June 15, 2021, via the electronic form available on Anvisa’s website.

Regulatory reliance with foreign authorities

Public Consultation No. 1,039 of April 08, 2021 (CP No. 1039/2021) intends to establish a resolution on the general criteria for using foreign regulatory authorities’ analysis for products subject to sanitary regularization. The text establishes general criteria to confirm whether there is sufficient similarity between the foreign authority and Anvisa to conduct a collaborative process, and to verify the admissibility of a regulatory document originating from foreign regulatory agencies.

The proposal establishes that the equivalence status for a foreign authority may be requested either by an Anvisa technical department or by the foreign authority itself, which will be subject to a decision from the Anvisa Executive Board. To do so, the entity must have regulatory practices similar to the Brazilian authority, ensuring the same level of healthcare protection – including regulatory jurisdiction.

Moreover, the draft proposes an expedited pathway for analyzing products subject to regularization based on technical assessments or regulatory dossiers already validated by a foreign agency deemed equivalent by Anvisa. Among other requirements, it must be demonstrated that the product approved abroad is identical to the one subject to Anvisa’s analysis.

Contributions to Public Consultation No. 1,039 can be made until June 15, 2021, via the electronic form available on Anvisa’s website.

Importation, commercialization, and donation of used and refurbished health products

Public Consultation No. 1,043, of April 8, 2021 (CP No. 1.043/2021) seeks to revise ANVISA RDC Resolution No. 25, of February 15, 2001 (ANVISA RDC No. 25/2001), which regulates the importation, commercialization, and donation of used and reconditioned health products.

Anvisa seeks to revise and adapt the regulatory requirements for used and reconditioned health products to allow the importation, commercialization, and donation of used or reconditioned medical devices – as long as the applicable criteria are met. Implantable medical devices (IMD), however, are excluded from this revision. Furthermore, Anvisa seeks to establish regulatory requirements regarding new health product negotiation possibilities, such as lending, leasing, or trade-in. Finally, it seeks to update and harmonize the concept of equipment reconditioning, according to the International Electrotechnical Commission’s (IEC) standards.

The proposal suggests that the following rules should be complied with:

• Only equipment that Anvisa authorized on the date it first entered the Brazilian market can be commercialized and donated. Regarding reconditioned equipment, only products with Anvisa’s authorization would be eligible for importation, manufacturing, or commercialization in Brazil.
• The commercialization and donation of used equipment for professional use will only be permitted for healthcare establishments and companies registered with Anvisa through an Operating Permit (AFE) that allows for the distribution of health products. This would be subject to a previous evaluation by a duly qualified technician at the competent professional council to ensure the product’s safety.
• For the commercialization or donation of products considered critical and life-supporting (classified as risk category III), a technical report would be required from a Brazilian company, authorized by either the marketing authorization (MA) holder at Anvisa or by the manufacturer responsible for the equipment, attesting that the technical specifications and conditions of use defined by the manufacturer are met.

Contributions can be made until May 14, 2021, via the electronic form available on Anvisa’s website.

Good Manufacturing Practices Certification for health products

Public Consultation No. 1,041, of April 8, 2021 (CP No. 1,043/2021) aims to review and improve ANVISA RDC Resolution No. 183, of October 17, 2017 (ANVISA RDC No. 183/2017), addressing inspection programs and administrative procedures for granting Good Manufacturing Practice Certification (CBPF) to health product manufacturers.

Said regulation already brought innovations to the Brazilian regulatory framework by enabling the granting of the CBPF for health products through documentary analysis of inspection reports conducted by international health authorities to reduce international inspections the unnecessary use of Anvisa’s resources.

Among other aspects, the proposal indicates the need to obtain a CPBF to health products classified as risk III or IV and that are manufactured in units that:

• Produce a finished product on their behalf or for another company;
• Prepare the finished product’s release – associated with at least one production step, excluding the design, distribution, sterilization, packaging, and labeling steps;
• Develop medical software (SaMD).

In addition to the above, the proposal provides that the granting of the CBPF should occur through:

• An evaluation of the documents required for companies inspected by countries that are members of an international audit program or have a report issued by audit bodies that have Anvisa’s recognition;
• Risk analysis to substantiate the granting of the CBPF;
• By evaluating Anvisa’s inspection report after an on-site inspection.

Contributions can be made until May 31, 2021, via the electronic form available on Anvisa’s website.

For more information about health-regulated products, contact Mattos Filho Life Sciences and Healthcare team.