MedPort Africa Group handles regulatory registration, licensing and market entry for medical devices and medicines in South Africa, from the first dossier to the first delivery.
South Africa's rules for health products are specific, and they're changing. We take care of the regulatory work so manufacturers can focus on the product and patients can get it sooner.
Dossier preparation in the format SAHPRA expects, submission, and managing evaluation queries through to approval.
Establishment licences for companies that import, distribute or wholesale medical devices in South Africa.
Getting ready for SAHPRA's phased product registration, building on approvals the device already holds elsewhere.
A South African point of contact for overseas manufacturers, responsible for regulatory correspondence and obligations.
Permits, customs and the right partners, so approved products reach pharmacies, hospitals and practices.
Keeping products compliant once they're on the market, from safety reporting to renewals.
Every product follows the same four stages. The detail inside each one depends on what the product is and where it's already approved.
We classify the product, map the regulatory pathway and identify gaps in the existing evidence.
We build the dossier, quality documentation and South African labelling.
We file with SAHPRA, answer evaluator queries and keep you informed at each step.
We put licensing, import and distribution in place, then keep the product compliant.
Our work sits between the companies that make health products and the people who need them.
International brands entering South Africa that need a local partner to register, import and distribute their products.
Local businesses adding new products who need licensing, classification or registration support.
Clinicians and practices who want to tell us which treatments their patients are waiting for.
Products we're working to bring to South African patients right now.
Bringing tubeless insulin delivery technology to South Africa. Omnipod South Africa is an initiative of MedPort Africa Group, exploring access for patients and healthcare professionals.
Visit Omnipod South AfricaOmnipod is a trademark of Insulet Corporation. MedPort Africa Group and Omnipod South Africa are independent and not affiliated with, endorsed by or sponsored by Insulet.
Tell us about the product and where it's approved today. We'll come back to you with the likely pathway and next steps.
Prefer email? hello@medport.co.za
Thank you. We'll reply to the email address you gave us.