LIFE SCIENCES & HEALTHCARE LAWyers | south africa

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.

Non-compliance with regulations from bodies like SAHPRA or HPCSA can result in fines, product recalls, or license suspensions.

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.

Medical law covers the legal framework governing healthcare providers, medical practitioners, and healthcare businesses – including regulatory compliance with bodies like the HPCSA and SAHPRA, informed consent, patient confidentiality, medical negligence, and the commercial and regulatory issues involved in running a healthcare practice or business. For healthcare businesses specifically, it also touches licensing, medical device and medicine regulation, and data protection for patient information.

Healthcare businesses employing or contracting with registered health professionals need to ensure those practitioners remain in good standing with the Health Professions Council of South Africa (HPCSA), and that the business’s own practices – advertising, fee structures, and clinical governance arrangements – don’t inadvertently breach the ethical rules the HPCSA imposes on its registered members. This is a particular risk area for corporate or investor-backed healthcare businesses operating alongside independently regulated practitioners.

Patient information is classified as “special personal information” under POPIA, attracting a stricter compliance standard than general personal information, including tighter conditions on when it may be processed and who may access it.

Medical devices and medicines intended for the South African market generally require registration with, or authorisation from, the South African Health Products Regulatory Authority (SAHPRA) before they can be marketed or sold, with the specific requirements varying by product classification and risk category. For businesses bringing new health products to market, SAHPRA’s registration timelines and requirements are often a critical path item that should be factored into commercial planning from an early stage.