Last month the Thai FDA promulgated that the medical device application pre-screening time would be reduced from 30 days to 1 day. In addition, the time to review Class 2-4 device applications would decrease from 200 days to 120 days if an expert... Read More
With political tensions in China growing and more companies trying to reduce costs, more and more Western drug and device companies will look to do clinical studies in India. While India accounts for close to 18% of the world’s population, its share... Read More
1. Overview The Central Drugs Standard Control Organization (CDSCO) functions as India’s primary regulatory authority overseeing pharmaceuticals, medical devices, and cosmetics. The CDSCO is also responsible for supervising the Drugs Consultative Committee (DCC), the Drugs Technical Advisory Board (DTAB), and the Central... Read More
A recent report by Bain & Company and APACMed (a MedTech trade association located in Singapore) has issued a report on Asian MedTech companies’ growing appetite for ESG initiatives. According to this report, the Asia region has doubled its ESG policies compared... Read More
As noted in our July newsletter, the Indian authorities required all non-notified Class C and D devices to be registered by October 1. Such devices could include certain X-ray products, ventilators, etc. that have moderate to high risks. However, some medical device... Read More
India provides the world with many drug products and drug substances. To ensure high quality, the Union Health Ministry now requires that all state drug authorities gather data on all Indian pharmaceutical companies. The Indian central government wants to collect information on... Read More
The Indian government issued the National Medical Device Policy 2023 to help develop more locally-made medical devices in India. Currently, India imports about 82% of their medical devices and the Government is looking to change this. While this 2023 Policy was a... Read More
Recently, India Central Drugs Standard Control Organization (CDSCO) announced that all Class C and Class D non-notified medical devices will need a comprehensive license by October 1st, 2023. In 2020, the Indian Ministry of Health and Family Welfare outlined its definition of... Read More
Before 2013, there were hundreds of clinical trials done in India that resulted in faulty data, lawsuits, and significant problems. From 2013 to 2019, the number of clinical trials in India dropped significantly. However, in 2019, India implemented New Drug and Clinical... Read More
In 2020, India promulgated their Medical Device Rules Act. This act increased medical device registration requirements in India. Before the act, only about 35 device categories required registration. After the act, all previous non-regulated devices now need CDSCO approval. Initially, non-regulated Class... Read More