The Regulatory Nexus: Borderline Product Classification

📢 DDReg Knowledge Capsule – Episode [19]These products, which often exhibit characteristics overlapping categories like medicines, medical devices, and food supplements, present a significant challenge because misclassification carries substantial compliance risks and can severely delay market entry. Regulatory authorities determine the necessary classification pathway—which dictates obligations such as Good Manufacturing Practices (GMP) and post-market surveillance—by evaluating a product's intended purpose, scientific mode of action, and all associated product claims. Given that classification standards often vary across global jurisdictions, the article stresses that manufacturers must adopt a proactive strategy, securing early regulatory consultation and preparing robust scientific justification.https://resource.ddregpharma.com/blogs/understanding-borderline-products-regulatory-classification-challenges-and-strategy/