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
Two weeks ago, India’s Union Cabinet, the top decision-making body in India, authorized a new medical device policy to increase its domestic device production. Currently, India only makes about 1% of the world’s medical devices and this new policy aims to increase... Read More
So many Western drug companies source drug products, drug substances, excipients, and drug packaging from China. Many have speculated given the tensions between the world’s two major superpowers – the US and China – this may be a dangerous situation. The COVID... Read More
While telemedicine is now common in the West, it is also now growing in Asia. Some Asian countries recently outlined new telemedicine regulations. For example, Taiwan’s MOH recently announced draft amendments to their initial telemedicine regulation of 2018. Originally, telemedicine was to... Read More
The Medical Technology Association of India (MTaI) has recently requested the Indian government to enact reforms in the Union Budget of 2023. These reforms coincide to the Modi government’s desire to improve healthcare in India. One of their suggestions is to lower... Read More
Starting January 1, 2023, the Indian government requires all Active Pharmaceutical Ingredients (APIs) manufactured in India to have QR codes. The reason for this government initiative is to help guarantee the quality and safety of APIs. Historically, about 20% of APIs made... Read More