Central Drugs Standard Control Organisation (CDSCO) is the apex regulatory body for medical devices, drugs, and cosmetics in India. The CDSCO works under the guidance of Medical Devices Rules (MDR), 2017. The Drug Controller General of India (DCGI) is the governing...
Transport validation is performed to demonstrate the device will remain safe during transportation. Additionally, it ensures the device will perform as intended when they reach the end user. Hence, performing transport validation is a mandatory requirement for most...
Process validation for medical devices is performed to demonstrate the finished product will consistently meet quality specifications and user requirements. Hence, regulatory authorities require manufacturers to perform process validation to demonstrate their finished...
In this blog, we have discussed what is medical device packaging validation and how to perform it. Additionally, we have highlighted the need for performing packaging validation for medical devices. What is medical device packaging validation? Medical device packaging...
The Indian cosmetics industry is booming. Hence, all cosmetics products have to be strictly regulated to ensure the safety of Indian consumers. Cosmetics products have to be manufactured by a licensed manufacturer and labelled and packed in accordance with Cosmetics...