A Practical Guide to Investing in Africa – a

Regulatory Perspective

SAMED GENERAL MEMBERS MEETING – 30 JUNE 2016

Avanthi Govender Bester

Regulatory Affairs Manager – Africa

Becton Dickinson

DISCLAIMER

• Intent vs actual

• Published vs Implemented

• Promise vs Practice

KEY CONSIDERATIONS • Which country/countries?

• Who/what is the legal authority that claims jurisdiction over medical devices?

• What is the classification of your products?

• What technical and quality documentation do you have ?

• Local Representation

Country and Region

Algeria

Angola

Botswana

Ethiopia

Gh

ana

Kenya

Morroco

Moz

Nigeria

South Africa

Egypt

Tanzania

Zambia

Tunisia

Legal Authority

Legal Authority

Legal Authority

• Ministry of Health

• Pharmaceutical Authority

• Laboratory Authority

• Professional Authority

• Bureau of Standards

• Importation Authority

Registration Fees

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COUNTRY FEES (USD) (approx.)

Algeria 1000 – 2400

Ethiopia 500

Ghana 900 – 2400

Kenya 25 – 600

Nigeria 2000

Tanzania 25 - 1050

Product Classification • Medical Device

- class

- purpose or intent

- raw material

• IVD

- class

- purpose or intent

- raw material

• HS Code

Available Documentation COMMON REQUIREMENTS:

• Product registration /establishment Licence

• CE mark or similar,

• ISO13485 certificates for the manufacturing sites,

• Technical documentation

• Certificates of Free Sale

• Application form

• Quality certificates

• Manufacturing license

• Packaging and samples

Local Representation

• Legal entity

• Mandatory Requirement (?)

• Country-specific labelling requirements

• Clarity and consistency of requirements

Published guidelines improve the understanding of requirements for registration

• Distributor Management

In countries where there is no local presence of the manufacturer – contracts need to be thorough to incorporate the regulatory responsibilities of the distributor e. recall procedures

Regional Challenges

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• Pharmaceutical applications

Requests for information not relevant to MDs/IVDs need to be removed from requirements and guidelines eg. GMP certificates

• Multiple and duplicate regulatory pathways

In some countries, several authorities claim the legal mandate to regulate medical devices therefore creating more than one registration pathway for a product. This results in increased costs, increased time to market, and duplication of efforts by the manufacturer. These legal mandates can take many years to resolve

(Professional Councils, PVoC, WHO PQ, etc)

Regional Challenges cont.

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QUESTIONS/ COMMENTS?

A Practical Guide to Investing in

Africa A Business Perspective

Andre Roberts

Becton Dickinson (BD)

Business Manager – Africa

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BD in Africa

• > 25 years direct presence

• ~200 associates

• 4 regional offices

• > 70 partners (agents / distributors)

• Segment focus in both public and private

sectors: o Laboratory

o Hospital

o Retail / Pharmacy

o Industrial

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Africa

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Meanwhile…

Key Strategic Considerations • Africa is not one country

• There is such a thing as ‘African Time’

• South Africa is not as ‘revered’ as you might

think

• Cultural differences should be a critical part of

the decision making process

• Understanding of country specific healthcare

needs and priorities is paramount

• Ministries want to see ‘genuine’ investment

(knowledge / people)

• The private sector is small but growing rapidly

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Strategy Development

• Country and Market Mapping

• Country Supply Chain

• Funding Flow for Key Projects

• Product Flow (logistics)

• Regulatory Requirements

• The Role of Implementing Partners

• Key Stakeholders and Key Opinion Leaders

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And Finally • Funders are Key…

• Build your strategy around the ‘Global Plan for

Sustainable Development’

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(Google it)

Thank You

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