Gillner, SandraSandraGillnerBlankart, Katharina ElisabethKatharina ElisabethBlankartBourgeois, Florence TanyaFlorence TanyaBourgeoisStern, Ariel DoraAriel DoraSternBlankart, Carl RudolfCarl RudolfBlankart0000-0001-6719-00382024-10-292024-10-292024-11https://boris-portal.unibe.ch/handle/20.500.12422/125334Countries with small and/or less-resourced regulatory authorities that operate outside of a larger medical product regulatory system face a regulatory strategy dilemma. These countries may rely on foreign well-resourced regulators by recognising the regulatory decisions of large systems and following suit (regulatory reliance); alternatively, such countries may extend formal decision recognition to regulators in multiple other jurisdictions with similar oversight and public health goals, following a system which we call regulatory pluralism. In this policy comment, we discuss three potential limitations to regulatory pluralism: (i) regulatory escape, in which manufacturers exploit regulatory variation and choose the lowest regulatory threshold for their product; (ii) increased fragmentation and complexity for countries adopting this approach, which may, in turn, lead to inconsistent processes; and (iii) loss of international bargaining power in developing regulatory policies. We argue that regulatory pluralism has important long-term implications, which may not be readily apparent to policy makers opting for such an approach. We advocate for the long-term value of an alternative approach relying on greater collaboration between regulatory authorities, which may relieve administrative pressures on countries with small or less-resourced regulatory authorities, regardless of whether countries pursue a strategy of domestic regulation or regulatory pluralism.enInnovationMedical device regulationPatient pafetyRegulatory pluralismRegulatory relianceSecurity of supply600 - Technology::610 - Medicine & health300 - Social sciences, sociology & anthropology::350 - Public administration & military science300 - Social sciences, sociology & anthropology::330 - Economicsarticle10.48620/748953930558610.1016/j.healthpol.2024.105164