We assist businesses in all areas of Life Sciences & Healthcare Law
Our Life Sciences & Healthcare Law team supports medical professionals, healthcare startups, pharmaceutical companies, medical device manufacturers, and telehealth providers in navigating the growing complexity of healthcare regulation in South Africa in the following areas:
- Telehealth & Telemedicine
- Supply Chain & Distribution Regulations
- Marketing, Advertising & Labelling of Medicines
- Medical Devices & Complementary Medicines
- Establishment Licenses for Medical Devices
- Medical Pricing and Clinical Trial Compliance
With increased scrutiny from regulators like the Health Professions Council of South Africa (HPCSA) and SAHPRA, it’s critical that businesses in the healthcare space meet their legal obligations with confidence. We provide clear, commercially focused advice to ensure our clients stay compliant and competitive across all stages of growth.
Our Life Sciences & Healthcare Law services include drafting and reviewing contracts for telehealth platforms, advising on regulatory compliance, supporting medical device establishment licensing, guiding clinical trial legal processes, and ensuring that medicine pricing, marketing, labelling, and advertising align with current legal frameworks.
In particular, the Caveat Legal Team can assist clients with:
Operating in digital health and telemedicine: Advising on telehealth regulations, drafting terms of use, and ensuring compliance with HPCSA and cross-border service guidelines;
Importing, manufacturing or distributing medical devices and complementary medicines: Assisting with SAHPRA registration, obtaining establishment licences, and reviewing labelling and packaging for compliance;
Running clinical trials or pricing new products: Providing legal guidance on trial documentation, participant protection, and ensuring local and international regulatory compliance;
Marketing pharmaceuticals or healthcare products: Ensuring that any advertising or marketing of products is compliant with the relevant legislation and guidelines published by the Marketing Code Authority.
We also advise healthcare clients on commercial contracts, intellectual property, and regulatory strategy, ensuring that legal risks are managed proactively.
The regulatory environment in healthcare is shifting fast, especially in areas like telemedicine and complementary medicine. My goal is to help clients cut through complexity and meet compliance standards without slowing down innovation.
— Simone Izzard, Panel Expert
Clients
Key laws and regulatory bodies that apply to Healthcare Law in South Africa include:
- Medicines and Related Substances Act, 1965
- Health Professions Act, 1974
- National Health Act, 2003
- Marketing Code Authority
- South African Health Products Regulatory Authority (SAHPRA)
- Health Professions Council of South Africa (HPCSA)
- Consumer Protection Act, 2008
- Protection of Personal Information Act, 2013
- Companies Act, 2008
- Medical Schemes Act, 1998
Legal Advice for Franchisors
Legal Advice for Franchisees
FAQs
Frequently asked questions in the Life Sciences & Healthcare legal space
We assist with regulatory compliance for telehealth, medicine advertising, device licensing, clinical trials, and more.
Startups in digital health, pharmaceutical companies, clinical trial sponsors, complementary medicine producers, and medical device manufacturers.
Yes, we provide guidance on how to legally offer remote healthcare services in accordance with SA and international regulations.
It’s a regulatory requirement for companies that import, manufacture, or distribute medical devices in SA. Caveat helps with the full licensing process.
Absolutely. We help sponsors navigate multi-jurisdictional trials, ensuring compliance with all relevant ethical and legal frameworks.
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