India Issues New Rules On Medical Device Manufacturing

July 5, 2006

With the aim of increasing confidence in the manufacturing of medical devices in India, new guidelines were issues regarding the import, manufacture and sale of all sterile devices in India, according to a July 4 report on In-PharmaTechnologist.com . ...

Adrienne Selko

The guidelines, which were issued by India's Central Drugs Standard Control Organization (CDSCO), give manufacturers 60 days to obtain a license for medical devices they already manufacture in India. The current devices manufactured such as cardiac stents, drug eluting stents, catheters and orthopedic implants can be sold for up to six months until an application is approved or rejected.

Registration fees of $1,500 per manufacturing premise will be levied on device manufacturers with a fee of $1,000 per single device. This $1,000 fee would not be applicable of the device only varies in size or shape without any change in the material method of use.

For new companies entering the Indian market a license must be obtained prior to commencing manufacturing.

Importers and retail sellers of medical devices must obtain sale licenses from the State Licensing Authorities for the medical devices they distribute within the next three months.

About the Author

Adrienne Selko | Senior Editor

Focus: Workforce, Talent

Follow Me on Twitter: @ASelkoIW

Bio: Adrienne Selko has written about many topics over the 17 years she has been with the publication and currently focuses on workforce development strategies. Previously Adrienne was in corporate communications at a medical manufacturing company as well as a large regional bank. She is the author of Do I Have to Wear Garlic Around My Neck? which made the Cleveland Plain Dealer's best sellers list. She is also a senior editor at Material Handling & Logistics and EHS Today.

Editorial mission statement: Manufacturing is the enviable position of creating products, processes and policies that solve the world’s problems. When the industry stepped up to manufacture what was necessary to combat the pandemic, it revealed its true nature. My goal is to showcase the sector’s ability to address a broad range of workforce issues including technology, training, diversity & inclusion, with a goal of enticing future generations to join this amazing sector.

Why I find manufacturing interesting: On my first day working for a company that made medical equipment such as MRIs, I toured the plant floor. On every wall was a photo of a person, mostly children. I asked my supervisor why this was the case and he said that the work we do at this company has saved these people’s lives. “We never forget how important our work is and everyone’s contribution to that.” From that moment on I was hooked on manufacturing.

I have talked with many people in this field who have transformed their own career development to assist others. For example, companies are hiring those with disabilities, those previously incarcerated and other talent pools that have been underutilized. I have talked with leaders who have brought out the best in their workforce, as well as employees doing their best work while doing good for the world.