Regulatory Affairs

Current group priorities

  • Actively engaging in shaping the  regulatory policies in the  region, by communicating the latest regulatory intelligence, and  advocating industry challenges and priorities.
  • Building capacity initiatives with internal and external stakeholders: educational sessions and training for members and regulators.
  • Cross Collaboration with GMTA and other trade associations on global topics and Africa.
  • Raising awareness around good regulatory practices, convergence and reliance, and addressing MDR/IVDR impact on the regulations in the region.
  • Developing and delivering a regulatory training program for Mecomed distributors around RA documentation and product lifecycle.
  • Engaging in shaping the UDI requirements in the region via industry recommendation paper and awareness workshop.

Members benefit from

  • Synergy of unified industry approach to ensure issues are escalated & discussed properly with authorities & awareness is created in alignment with international standards.
  • Sharing best industry practice among member companies and educational sessions for the committee members on key RA topics globally and regionally.
  • Access to database information on the regulatory requirements per country and other related regulatory topics.
  • Well established partnership with regional regulators regarding regulatory matters & capacity building initiatives.
  • First-hand members updates on the regulatory changes in the region.

Rana Chalhoub
Regulatory Affairs Director
[email protected]

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