SAMED, as represented by Executive Officer Tanya Vogt, attended the USTDA workshop on Regulatory Convergence for Healthcare Products in Southern Africa. The workshop sessions covered medical device and medicines regulatory frameworks, reliance models, impact assessments and industry perspectives.
Tanya acted as moderator for the session on the implementation of reliance models. This session unpacked the critical role of regulatory harmonisation and ensuring a collaborative effort to close gaps between concept and implementation. Current gaps include different versions of a product being marketed in different markets, overly redacted inspection and assessment reports, assessor hesitancy to use these pathways, and national “requirements” that need reassessment.
Airing these gaps in a multi-stakeholder setting allows for collaborative problem-solving that works across regulators and industries and we look forward to continued engagement.