Regulation of Law No. 26,906 on the “Regime of Traceability and Verification of Technical Aptitude of Active Medical Devices in Use”

On October 10, 2023, Decree No. 517/2023 (the “Decree”) was published in the National Official Gazette, approving the regulation of Law No. 26,906 (the “Law”), which established the Regime of Traceability and Verification of Technical Aptitude of Active Medical Devices, the metrological traceability of such products and the creation of the Biomedical Technology Services, with the purpose of advancing with its implementation.

In this regard, the annex that forms part of the Decree (the “Annex”) provides further definitions, requirements, responsibilities, and other clarifications with respect to Active Medical Devices (or “AMDs”) and the Law.

Section 2 of the Decree grants the Ministry of Health, in its capacity as enforcement authority, the power to issue the complementary and/or clarifying rules that may be necessary for the effective implementation of the system.

In accordance with a gradual implementation of the Law, the Annex sets forth the following:

1. The Ministry of Health will establish the stages and priorities for the application of the Active Medical Device in Use typology until its totality is completed, over a period of no more than 24 months. In addition, the Ministry will be responsible for defining the mechanisms for the implementation and progressive habilitation of the Clinical Engineering Services.
2. Section 3.4 of the Annex further adds to the definition of “Biomedical Technology Service” (or “BTS”) by indicating that this term and “Clinical Engineering Service” (or “CES”) are synonymous.
3. Regarding the approval of Active Medical Devices, it is accepted to consider integral approval certifications per establishment, according to the procedures and verification records of each Active Medical Device in use.
4. It is established that the technical verification tests, needed for obtaining the approval certificate of AMDs in use in health institutions, may be conducted by: (i) the BTS of each institution; (ii) the services assigned to the Secretary or jurisdictional Ministry of Health; or (iii) a CES located in a designated seat for this purpose.
5. Regarding the responsibility of the “Personnel Responsible for the AMDs” in the health centers, it is stipulated that health centers must keep a record of the AMDs in use in each institution to allow their identification and traceability and must register them in the “Federal Register of Health Centers”. It is also established that this registry will be updated annually by the local authority and/or by the health centers.
6. Section 13 of the Annex provides further clarification on the requirements to be met by the Responsible of the Biomedical Technology Service, by indicating that he/she may demonstrate his/her expertise in the field through a degree and/or a postgraduate degree which includes advanced knowledge in clinical engineering.
7. The Ministry of Health, pursuant to Section 23 of the Law, grants the Health Authorities of each jurisdiction the authority to determine the applicable administrative procedure for the investigation of alleged infractions.