Impact of change in address of the foreign manufacturer or its manufacturing site
In India, the manufacturing sites are used to determine whether to grant a manufacture or import licenses. In a nutshell, the licenses in India are site-specific. Prior to now, a change in the foreign manufacturer’s or its manufacturing facility’s address was regarded as a significant change and it necessitated the submission of a new import license application on the […]
Regulation of all medical devices in India by Oct 1, 2023
Starting October 1, 2023, ššš ššš-šššššššš šŖšššš šŖ ššš šŖšššš š« š“šš šššš š šššššš shall be subject to the requirements of the š“šš šššš š«ššššš š¹šššš 2017. Since October 1, 2022, all non-notified Class A and Class B medical devices are subject to the š“šš šššš š«ššššš š¹šššš 2017 and the manufacturers, whether local or foreign, are required […]
Obtaining a Loan License for Medical Devices in India from CDSCO
The medical device sector in India is witnessing remarkable growth and innovation, making it an enticing prospect for entrepreneurs and businesses. However, one of the significant hurdles is the substantial investment required for manufacturing infrastructure. To circumvent this, manufacturers can utilize the facilities of another company that already possesses the infrastructure to produce the desired […]
