In 2020, India promulgated their Medical Device Rules Act. This act increased 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 A and... 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
Historically, there have been more drug clinical trials in the West than in Asia. However, recently this has changed, and there are more than 8,000 clinical trials in Asia now and less than 8,000 clinical trials in the West. Please note that... Read More
In late October, India’s Ministry of Health and Family Welfare has set up a committee to put together an extensive drug database. The committee will initially include 7 people. The goal of the drug database will be to provide an exhaustive record... Read More
By this past October, device manufacturers and importers of Class A medical devices are required to register their products via an online portal. The manufacturer or importer will also need to confirm that their device meets the requirements of the essential principles... Read More