Regulatory Insights
Compliance intelligence,
in plain language.
Practical guidance on SAHPRA submissions, pharmaceutical labelling, and regulatory documentation for South African regulated industries.
12 articles
Post-Market Surveillance for Medical Devices: South African Obligations Explained
What post-market surveillance requires under the MDA, incident reporting timelines and thresholds, field safety corrective actions, vigilance reporting to SAHPR
Advertising and Promotion of Medicines in South Africa: What the MCA Code Allows
Overview of the Medicines and Related Substances Act advertising provisions and MCA Code of Marketing Practice, what constitutes a promotional claim, the differ
Packaging Requirements for Dangerous Goods Under SANS 10228: A Practical Guide
UN-certified packaging requirements, how to read a UN packaging mark, when combination packaging is required, inner and outer packaging selection by packing gro
SAHPRA QMS Requirements for Medical Device Manufacturers: What ISO 13485 Alone Won't Cover
How SAHPRA's QMS expectations differ from ISO 13485, what local registration requires beyond the international standard, common gaps found during SAHPRA audits,
Cosmetics vs Medicines: How SAHPRA Draws the Line
The legal distinction between a cosmetic and a medicine under South African law, how claims and ingredients determine classification, products that frequently f
Post-Registration Amendments in South Africa: What Triggers a New SAHPRA Submission
Explain the difference between major, moderate, and minor amendments, what changes require prior approval vs notification, common triggers (labelling, manufactu
Health Claims on Consumer Products: The R146 Regulations Explained
What health claims are permitted under the Foodstuffs, Cosmetics and Disinfectants Act and R146 regulations, what substantiation is required, the difference bet
Dangerous Goods Classification Under SANS 10228: A Practical Guide for Transport Operators
How to correctly classify dangerous goods under SANS 10228, UN number selection, packing group assignment, common misclassifications and their consequences, SAD
What SAHPRA Looks for in a Pharmaceutical Artwork Review
Artwork rejections are one of the most common causes of submission delays in South Africa. Here is what SAHPRA checks and how to get it right the first time.
Veterinary Product Labelling in South Africa: What Act 36 of 1947 Actually Requires
Mandatory label elements under Act 36, withdrawal period requirements for food-producing animals, scheduling declarations, species restrictions, and common non-
SAHPRA Medical Device Registration: What Has Changed and What It Means for Manufacturers
Overview of SAHPRA's medical device registration pathway, key requirements under the MDA, ISO 13485 alignment, technical file expectations, and common gaps in a
The MLR Review Process: A Practical Guide for Regulatory Affairs Teams
What MLR review is, who should be in the room, how to structure the file, what documentation is needed, common bottlenecks and how to avoid them