Regulatory Blog

The South African Health Products Regulatory Authority (SAHPRA) has issued the Guideline for Borderline Products to help determine the appropriate regulatory pathway for products where classification is unclear. The guideline addresses products that may fall within categories such as medicines, medical devices, cosmetics, disinfectants, foodstuffs or other consumer products. Classification is determined on a case-by-case basis. What Are Borderline Products? Borderline product

Determining whether a product qualifies as a medical device is one of the most important regulatory decisions for manufacturers before placing a product on the Great Britain market. Many products fall into a "borderline" category because they may share characteristics with medicines, cosmetics, food supplements, biocides, personal protective equipment (PPE), or other regulated products. To provide greater regulatory clarity, the Medicines and Healthcare products Regulatory Ag

In the ever-evolving world of pharmaceutical and medical product regulation, correctly classifying your product is crucial. Some products fall into a “grey area” where they could be regulated as a medicinal product, a medical device, or another type of product such as a cosmetic, food supplement, or biocide. To help manufacturers and other stakeholders make this determination, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) publishes detailed guidance on h