On July 8, the Indian government issued new legislation to get shareholders’ feedback. This legislation started in 2016 and is trying to replace the Drugs and Cosmetics Rules of 1945. New definitions for investigational new drugs, medical devices, clinical trials, etc. were included. New severe penalties... Read More
The Indian CDSCO is now discussing the need to test more devices locally to obtain Indian medical device approval. Recently, a task force has been established to determine what needs to be done to increase India’s testing facilities. Various categories of medical... Read More
On May 18, the Ministry of Health and Family Welfare announced a new Rule 43A, which outlines the conditions in which an approved device license can be canceled or suspended. Per this new rule, if a device license does not comply with... Read More
In the latest move by India’s regulatory authority to better control the safety of medical devices, the Ministry of Health and Family Welfare announced in February that all retail and wholesale outlets selling medical devices in India will be required to register... Read More
With the COVID-19 pandemic making clear the urgent need to speed approvals and enable flexibility in pricing of innovative biopharmaceutical products, regulators in India have drafted a new set of measures to streamline innovative drug research and development. Released in draft form... Read More
In its latest move to better control the safety of medical devices for sale in India, regulators announced in September that a range of devices used in hospitals will be classified into six separate areas for the purpose of assessment and registration.... Read More
Fueled in part by increased demand as a result of the COVID-19 pandemic, the market for medical devices in India is expected to ramp up over the next four years at a rapid clip, according to a report from data analytics firm... Read More
In the latest move by India to ensure the quality and safety of medical devices produced in the country, government regulators are joining forces with leading medical device manufacturers associations to integrate industry quality management systems with regulatory requirements. The new framework... Read More
Spotify: https://open.spotify.com/episode/61krNTBfW9nKHadjtOOIuT?si=zGlmcBWnTUKGYT7qXOo1XQ&dl_branch=1 Apple: https://podcasts.apple.com/us/podcast/project-medtech/id1513851432?i=1000527075358 Read More
In a further tightening of its regulations on the sale of medical devices, India’s regulatory authority has announced a new list of devices that must obtain import and manufacturing licenses in order to be sold in the country. In accordance with the... Read More