Several regulatory convergence initiatives exist for the medical device sector: INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) – Conceived in 2011, this forum discusses future directions in medical device regula- tory harmonization. The IMDRF is a voluntary group of medical device regulators from around the world who come together to build on the foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and to accelerate international medical device regulatory harmonization and convergence. Brazil is currently the only Latin American full member country in the IMDRF. AdvaMed supports increasing the partic- ipation of Latin American medical device regulators in the IMDRF, by being invited as members or observers to facilitate an understanding and the adoption of recommended policies and standards. THE WORLD HEALTH ORGANIZATION (WHO) GLOBAL MODEL REGULATORY FRAMEWORK FOR MEDICAL DEVICES including IVD Medical Devices currently in draft form “is intended to provide guidance and support to WHO Member States that have yet to develop and implement regulatory controls relating to medical devices, as they take steps to ensure the quality and safety of medical devices available in their jurisdictions.” Key among the draft WHO Guidelines is the Chapter 4 “Stepwise approach in regulating medical devices” that, in recognition of the differing levels of development in which different countries may be, offers governments a prioritized layering of regulatory responsibilities that they can assume commensurate with their resources. “The stepwise approach will allow the regulatory authority to respond to national public health priorities and to progressively develop the capacity, knowledge and experience required. This approach helps the regulatory authority determine the resources needed for further implementation. Without effective implementa- tion of basic controls, the elements of expanded controls will be of limited value and difficult to manage effectively. The regulatory authority has an opportunity to reduce the demands on its own staff by either relying upon or recognizing the work or decisions made by another medical devices regulatory authority.” The WHO stepwise approach thereby offers authorities a full range of regulatory tools to ensure the availability of safe and innova- tive medical technologies within a particular border, maximizing leverage of existing international regulatory systems and outputs. For countries particularly focused on economizing scarce public health resources, these guidelines can provide the requisite policy framework allowing the acceptance of foreign regulatory approvals in lieu of creating duplicative or conflicting regulatory regimes or requirements. Regulatory Convergence “Regulatory Convergence” represents a process whereby the regulatory requirements across countries or regions become more similar or aligned over time as a result of the gradual adoption of internationally recognized technical guidance documents, standards and scientific principles, common or similar practices and procedures, or adoption of regulatory mechanisms that might be specific to a local legal context but that align with shared principles to achieve a common public health goal. It does not necessarily represent the harmonization of laws and regulations, which is not a prerequisite for allowing the alignment of technical requirements and greater regulatory cooperation. 10