The Gujarat Food and Drug Control Administration (FDCA) in association with the US FDA is organising a two-day training programme for the medical device industry in Ahmedabad from April 14 to 15. The two-day event aims at training the Indian medical device industry on the US regulatory guidelines so that they can explore the potential to export to the regulated market.
H G Koshia, commissioner of the Guj FDCA informed that as the Indian medical devices industry progresses towards high quality innovative products and services, the opportunity of exports is bound to increase. Both conventional as well as high range medical device manufacturers are available in the state of Gujarat. However, he added, “Almost all of these companies cater to the domestic demand today, and is not export oriented. The medical devices and equipments sector in India has a huge opportunity arising from the focus on affordable healthcare in different countries of the world and we want to explore this and utilise it in the international market which includes both regulated and unregulated market.”
Koshia informed that the Gujarat government is focusing on developing the medical device segment in the state especially by focusing on exports. “The medical device industry is globally competitive market thus is is important that we equip ourselves to global standards so that we can have a edge over our competitors. It is with this view that we are organising this training session for the companies with the US regulators so that it give them first hand information about what is to be expected from them when they plan to venture into regulated market.”
This training session will give details about the regulatory requirements that the companies need to follow if they want to venture into international market. This two day training workshop will be attended by Erin Keith US FDA India office assistant country director for medical device. She will be addressing to the industry and clearing the doubts regarding US regulatory guidelines.
Koshia informed that almost 40 companies have already registered for the event and that they are expecting more companies to participate in this training programme that is focused on the development of the medical device industry. He added that by attending this event the
industry will not only gain a better understanding of the requirements for exports to the developed countries, but will also be able to adopt best practices in their daily activity thus ensuring availability of quality products.