Partner with us today
and ensure compliant access to South Africa’s Health Technology Market.
About Afrihealth
Regulatory Consulting and Advisory Services
Afrihealth is a licensed medical device establishment which acts as Authorized Representative to effectively assist foreign based manufacturers of health technology enter into the South African market.
A manufacturer established outside South Africa would primarily appoint a locally based licensed medical device distributor to import and distribute their products. That Distributor would have an authorized representative appointed, which is South Africa is defined as a natural person resident in South Africa and usually an employee of the distributor.
Not all health technology will be physically imported, however there are also instances in which the manufacturers wish to ensure local regulatory compliance and control over their product registrations.
We are your trusted
Medical Device Compliance Partner
Our Services
This is where Afrihealth offers a unique blend of solutions tailored to client needs:
Providing Authorized Representative Services using a stand alone or an existing medical device establishment license.
In country support / regulatory oversight of third-party distributors where necessary to ensure regulatory compliance.
Ensuring Compliance in relation to:
• Traceability
• Recalls and Field Safety Notices
• Adverse event reporting
• Product Registration
• Distributors
We also assist in identifying partners for logistics, distrubtion and sales to promote the manufacturer’s product in South Africa.
Contact us
Partner with Us Today and Ensure compliant market access in South Africa’s Health Technology Sector
Get in touch, we’d love to hear from you:
Mark Banfield
Belinda Banfield
Afrihealth Head Office
1 Butt Street, Kenton on Sea
For service requests, feedback and complaints:
Afrihealth certified as a provider of Authorized representative services under ISO13485:2016
Afrihealth is associated with Mark Banfield & Associates Consulting (Pty) Ltd, who provide consulting and advisory services to health technology companies, focusing on Regulatory Compliance, Quality Assurance, Business development and Market Research www.mbac.co.za
@Copyright Africa Healthcare Holdings (Pty) Ltd.