Prequel Insights https://prequel.in/insights/ Guides, regulatory updates and sourced facts for regulated products in India. en-in Drug-device combination products: how India regulates them https://prequel.in/insights/drug-device-combination-products-india/ https://prequel.in/insights/drug-device-combination-products-india/ How India regulates drug-device combination products: the primary intended action test, Class D under the Medical Devices Rules, and US and EU routes. Guide Fri, 23 Oct 2026 00:00:00 GMT ICH E6(R3) is now final: what it means for trials in India https://prequel.in/insights/ich-e6r3-india/ https://prequel.in/insights/ich-e6r3-india/ ICH E6(R3) is final and in effect in the EU and US. What the new GCP guideline changes, where India stands, and what sponsors and sites should do now. Regulatory update Fri, 23 Oct 2026 00:00:00 GMT Medical device classification in India: how it works https://prequel.in/insights/medical-device-classification-india/ https://prequel.in/insights/medical-device-classification-india/ Medical device classification in India, step by step: the four risk classes, who decides, the First Schedule rules, and how the class sets your licence. Guide Fri, 23 Oct 2026 00:00:00 GMT Wellness devices: when India treats them as medical devices https://prequel.in/insights/wellness-devices-medical-devices-india/ https://prequel.in/insights/wellness-devices-medical-devices-india/ When do wellness devices, fitness wearables and health apps become medical devices in India? CDSCO's 2026 software guidance, the claims test and classes. Guide Fri, 23 Oct 2026 00:00:00 GMT