An FSVC Perspective on Changes to the Regulatory Framework Impacting Africa
A Practical Guide to Investing in Africa a Regulatory Perspective - … · 2019-11-18 · Avanthi...
Transcript of A Practical Guide to Investing in Africa a Regulatory Perspective - … · 2019-11-18 · Avanthi...
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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7/1/2016 Footer Text 18
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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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