Regulatory Affairs

regulatory

Members benefit from:

  • Synergy of unified industry approach to ensure issues are escalated and discussed properly with authorities and awareness is created in alignment with international standards.
  • Access to database information on the regulatory requirements per country.
  • First-hand members updates on the regulatory changes in the region.
  • Access to the regulators via group delegations and regulatory symposium, a platform for cooperation between regulators and the industry.
  • Well established relationships with regional regulators.

Current Group Priorities:

  • Ongoing Regulatory Intelligence & updates.
  • Advertising and Promotional requirements in MEA.
  • Industry Position paper around the importance of Post Market Surveillance for patient safety.
  • Engagement with Health regulators and other stakeholders (CAB, GS1, DHA, CCAD) for emerging trends like RoHS and UDI.
  • Assessment of regional impact of UDI, MDR, Brexit etc. and working with peer associations and international bodies to align regional activities with global regulatory developments.
  • Training for the Regulators around the basis of MD regulations and engaging in key regulatory events in the region, e.g. SFDA conference, AWHP meeting.