Regulatory frameworks for assistive products in Germany, Australia, Brazil, Canada, United States, and Japan

Abstract

The Global Report on Assistive Technology, jointly published by WHO and UNICEF, identified a gap regarding regulations for assistive products worldwide. However, it is noteworthy that understanding which countries have some regulation on the safety of assistive products, on the qualification of suppliers of these products, and on the provision of related services is essential for better contextualization for the Brazilian reality. Objective: To survey the regulatory framework adopted by the agencies of six countries selected by the Expert Committee for the selected priority assistive products. Method: Manual searches were conducted on regulatory agencies and health authorities regarding current regulatory standards of six countries chosen by the Steering Committee, namely: Brazil, Australia, Germany, Japan, Canada, and the United States. Subsequently, a research protocol was published for access by stakeholders. Results: The search was carried out in the six countries for information on general and specific regulations of the prioritized products, their health classification, information on registration, good manufacturing and distribution practices, labeling and marketing, surveillance, import and export, investigation, and penalties. All countries presented regulations for all items, but there is a scarcity of specific regulations for the prioritized devices. Conclusion: All countries presented regulatory standards for medical devices; however, there is a scarcity for specific devices. Furthermore, it is noteworthy that, in all countries studied, the regulations are similar to those used in the medical device risk classification system. The technologies studied are considered low-risk class and, therefore, subject only to notification, which may justify the absence of specific standards for these products.