SAHPRA, healthcare and life sciences regulatory counsel
Pharmaceutical, biotech, medical device and diagnostics businesses operate under one of South Africa's most demanding regulatory regimes. We pair that regulatory work with enforceable commercial contracts - backed by experience from inside the industry.
Taking a health product from laboratory to market in South Africa means clearing SAHPRA, the Medicines Act, clinical trial requirements and strict rules on advertising, labelling and pricing - while still signing commercial deals that hold up. JW van Zyl Inc advises pharmaceutical, biotechnology, medical device, diagnostics and healthcare businesses, research organisations and their funders across that full path.
What we advise on
- SAHPRA medical device establishment licences (manufacturer, distributor, wholesaler) and Authorised Representative arrangements
- Medical device and IVD registration readiness as SAHPRA's registration regime rolls out
- Clinical trial agreements (CTAs), study start-up, site and investigator contracting
- Medicine and medical device advertising, labelling, marketing and pricing compliance under the Medicines Act
- Telehealth, digital health and healthcare platform contracting
- Market-entry structuring, distribution and supply agreements for regulated products
- Regulatory governance, POPIA and confidentiality in clinical and healthcare settings
A lawyer - not only a consultant
Much SAHPRA support in the market comes from regulatory consultants. They are valuable for technical dossiers, but they cannot give you legal advice under privilege, draft and enforce the contracts behind a licence or distribution arrangement, or defend a decision if a regulator or commercial counterparty pushes back. We do that - and coordinate with technical consultants on the dossier where needed, so you have one legally accountable adviser over the whole matter.
Senior attention, without large-firm overhead
South Africa's ranked life-sciences regulatory bar is small and concentrated in the largest firms. We offer the same regulatory depth with direct senior access and without large-firm rates or layers - and our founder worked inside multinational healthcare and clinical research operations before practising law, so the advice reflects how approvals, studies and supply chains actually run, not just how the statute reads.
Common questions
Do I need a lawyer or a regulatory consultant for SAHPRA work?
Often both, for different things. A consultant can help compile a technical dossier; a lawyer gives you advice under legal privilege, drafts and enforces the agreements behind a licence or distribution deal, and protects you if a decision is challenged. We provide the legal side and coordinate technical consultants where required.
What is a SAHPRA medical device establishment licence and who needs one?
It is a mandatory licence for any business that manufactures, imports, exports, distributes or wholesales medical devices in South Africa, valid for five years, and it requires a South Africa-based Authorised Representative. We advise on the legal requirements, the Authorised Representative arrangement and the contracts that sit around it.
Can you advise on clinical trial agreements with overseas sponsors?
Yes. We regularly work with cross-border sponsors and CROs on clinical trial and study start-up contracting, balancing sponsor requirements with South African law and POPIA.
Do you handle medicine and medical device advertising and labelling compliance?
Yes. We advise on advertising, marketing, labelling and pricing of medicines and devices under the Medicines Act and SAHPRA requirements, including reviewing materials before they go to market.
Bringing a health product to the South African market?
Get regulatory and contracting advice from a lawyer who has worked inside the life sciences industry.
Start a conversationinfo@jwvanzylinc.com · WhatsApp +27 60 600 0274 · Cape Town