Towards Global Medical Device Regulatory Alignment: Changes in Latin American Markets

By Evangeline Loh

Medical device regulators in Brazil, Mexico and other Latin American countries continue to align their requirements more closely to those of other markets such as Europe and the U.S., as well as to regulatory guidelines from the International Medical Device Regulators Forum (IMDRF).

Emergo by UL consultants provided analysis of these promising regulatory developments at the 10^th Annual UGA-FDA Medical Device Regulations Conference held in late November in Athens, Georgia. The conference was replete with presentations from regulators including the US Food and Drug Administration (FDA) and European notified body representatives, medical device manufacturers, law firms, consultancies and academicians.

While many sessions focused on FDA-related topics, international issues were also covered on Day 1 of the conference. During this time, Emergo by UL consultants presented on recent developments in Latin America.

Towards global regulatory alignment

In particular, Emergo by UL focused on regulatory updates in Brazil and Mexico that have more closely aligned these market’s medical device registration and approval requirements with those of the European Medical Devices Regulation (2017/745 MDR) and IMDRF guidance.

The Emergo by UL presenters mentioned the creation of the Latin America and Caribbean Medicines and Medical Devices Regulatory Agency (AMLAC), a new organization established to promote and coordinate health security and access to medical supplies across Latin American and Caribbean markets. Recent and ongoing medical device-related activities of trade bloc MERCOSUR were also covered.

Presenters focused on the two largest Latin American medical device markets, Brazil and Mexico.

Regulatory Updates in Brazil

Brazil’s regulation RDC 751/2022  was promulgated in September 2022, replacing  RDC 185/2001 after 21 years and consolidating legislation related to ANVISA medical device regulatory and registration processes. RDC 751/2022 became effective in March 2023.

The European MDR definition of “medical device” was included as the definition in RDC 751/2022. The 22 rules from the MDR Annex VIII were adopted in the RDC 751/2022 in Annex I. The format of the Technical Dossier, Annex II, implemented the IMDRF guidance on market authorization.  

In addition, the regulatory registration moniker for the lowest risk medical devices, changed from Cadastro to Notificação. And, there were content updates to grouping of medical devices for regulatory submissions and labeling.

Brazilian regulator ANVISA also posted two consultations in September and October 2023 related to global harmonization initiatives. The first consultation announced proposed leveraging regulatory authorizations from four of the former Global Harmonization Task Force (GHTF) founding members. Use of a GHTF member authorization, excluding European compliance, would expedite the review process. The second consultation proposed extending Medical Device Single Audit Program (MDSAP) certificates used for Brazilan Good Manufacturing Practices (B-GMP) to four years.

Regulatory Updates in Mexico

In Mexico, the Supplement of Medical Devices of the Mexican Pharmacopoeia was revised as edition 5.0. (edition 4.0 was published 2017) effective July 10, 2023.

Mexican regulators included many of the definitions from the European MDR in Appendix III of the new edition. Similar to RDC 751/2022 in Brazil, Appendix II of the Mexican Pharmacopoeia edition 5.0 incorporates the 22 MDR rules.

The most significant revision was to ensure that software as a medical device (SaMD) would be considered an appropriately risk-classified medical device. There  were also updates to sanitary registration renewals and modifications and grouping criteria in Appendix IV.

Concluding Remarks

As medical device regulatory affairs professionals, we enjoy regulatory updates related to global harmonization. The year 2023 did not disappoint, and we remain even more excited for 2024.

(As an aside, we’re fortunate that so many well-organized and orchestrated medical device regulatory conferences exist. We would strongly encourage attendance at the 11^th Annual UGA-FDA Medical Device Regulations Conference as well as any other conference which fosters opportunities to exchange information and network.)