Summit Schedule

Kenya Health Tech
  • ½ day- Medical devices evaluation regulators only
  • ½ day- Industry (Medical device Quality Management Systems (QMS); Diagnostics

The coming into force of the African Continental Free Trade Area (AfCFTA) on May 30 2019 is one of the early achievements of the African Agenda 2063. Covering a population of 1.2 billion people with a combined GDP of US$2.5 trillion, AfCFTA will be a defining force in the harmonisation of regulations and standards to promote more open trade.

This session will look at market size and offer insights on

  • Political & Economic Situation
  • Competitors Overview - Current Landscape and local players
  • The markets with growth potential. Outlook of markets, macroeconomic tendencies, regulatory framework
  • Local distributor access
  • Logistics and physical hurdles – Exportation and other regulations to enter these markets
  • Local compliance and regulation - market access specific rules

To speak at this session we have invited regulators from Tanzania, Kenya, Uganda, Rwanda, Burundi, South Sudan and Ethiopia.

The session will give the overview of the regulatory framework of each country and allow to understand the requirements for MedTech registration and manufacturing in each country individually.

This Q&A session will allow industry and regulators to discuss practical aspects around the development of international standards and regulations.

  • What are the perceived challenges and opportunities in East Africa?
  • What global influences will shape standards harmonisation under AfCFTA?
  • What support can national governments offer industry?
  • What is a likely timescale?

Standards harmonisation will promote safety, quality and effectiveness for products and services across Africa. For manufacturers trading across borders, harmonisation with clear rules also means efficiency of scale which results in affordability and accessibility.

This session will look at how having the right regulatory frameworks in place makes a country attractive for investment. Besides making a key contribution to that nation’s health economy, this can foster better access for all for all those signed up to the same standards and shared regulations.

Being able to take part in an international market can pay dividends for those willing to invest in it. A large market also presents opportunities to try out innovations and then role out the successes to a wider user base where clinicians and patients want the best health care.

This session will discuss what drives innovation, and how harmonised standards and regulations can be used to promote better market access

We will close the Forum with an interactive session discussion.

The audience will be divided into 7 groups. Each group will have a leader – an expert from an authority or Industry, who will moderate the discussion and let the participants share their experience with product registration East Africa

  • Group 1: Kenya
  • Group 2: Tanzania
  • Group 3: Ethiopia
  • Group 4: Uganda
  • Group 5 Sudan
  • Group 6: Burundi
  • Group 7: Rwanda