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Policy Shaping & Advocacy

The innovative advocacy, global standards alignment, and ethics of MEDAK greatly improve Kenya's medical technology regulations.

Since its inception, MEDAK has been proactively collaborating with regional regulatory bodies to establish a regulatory framework that aligns with global standards and best practices. This collaboration is pivotal for providing patients in Kenya, and more broadly in Africa, with access to advanced and secure medical technology. As we navigate the transition from a free market system to a regulated environment, MEDAK champions this progression through dedicated efforts in harmonizing standards, responsive advocacy, and stringent compliance:

Harmonizing Standards and Strategic Regulation:

Engagements with PPB: Regular quarterly meetings with the Pharmacy and Poisons Board (PPB) focus not just on marketing high-quality Healthcare Products & Technologies (HPTs) in Kenya but also on aligning local standards with international benchmarks, ensuring a globally competitive regulatory environment.

Responsive Industry Engagement:

  • Resolving IVD Double Regulation: MEDAK's involvement led to the resolution of the double regulation issue by KMLTTB and PPB, exemplifying effective advocacy and streamlined regulatory compliance.
  • Advocating for VAT Exemption/Zero Rating: MEDAK's successful advocacy for VAT exemption and ongoing efforts for zero-rating reflect its commitment to responsive and beneficial regulatory changes.
  • Collaboration with KEBS: The revision of the Pre-Export Verification of Conformity (PVoC) manual and the push for the elimination of technical trade barriers like 3rd party test reports for CoC issuance represent MEDAK's dedication to harmonizing standards and removing unnecessary regulatory hurdles.

Ongoing Dialogue for Compliance:

Negotiation and Communication: Continuous negotiation and open dialogue ensure not just compliance with current regulations but also a responsive approach to upcoming changes. MEDAK ensures clear transition timelines, proper notifications, and the availability of comprehensive guidance documents, reflecting its commitment to responsive advocacy.
Through these concerted efforts in harmonizing standards, engaging in responsive advocacy, and ensuring compliance, MEDAK is not only enhancing the regulatory landscape but also ensuring that it effectively caters to the evolving needs of the Kenyan market. MEDAK's approach fosters a regulatory environment where innovation thrives, standards are internationally competitive, and medical technologies are both advanced and aligned with the paramount goal of patient safety and access