MEDICAL DEVICE
Querist :
Anonymous
(Querist) 27 May 2010
This query is : Resolved
Dear Experts,
I represent Quadio Devices, an early stage startup in the medical devices domain. Our activities range from R&D, Product design, manufacturing (we will most likely be contracting this activity), distribution and retail of digital hearing aids in India.
I would like to potentially get your expert advice on the regulations and compliance(s) (if any) that exist for a company of our activities specifically about:
1. Manufacture of digital hearing aids
2. Retailing of digital hearing aids
Kindly enlighten if you could help me, if you have any questions that will help you understand my requirements better, I would be happy to provide all sorts of information.
Thank you to all. Have a nice day.
Guest
(Expert) 27 May 2010
YOU MAY KINDLY SEND DETAILS OF YOUR EXHISTING BUSINESS AND THE LICENCES AND REGD.NO.IF ANY.AND CONTACT DETAILS AND LOCATION OF THE SAID MANUGACTURING AND OTHER OFFICES FOR JURISDICTION.
WILL HELP YOU.
THANKS.
NANDKUMAR B.SAWANT.M.COM.LL.B.(MUMBAI),ADVOCATE
MOBILE.9271971251, 9960223100
e.mail.adv.nbsawant@yahoo.co.in
e.mail.nandkumarbs@sify.com
.
Uma parameswaran
(Expert) 27 May 2010
A special evaluation committee is constituted by the Drug controller General of India (DCGI)to regulate the quality of the devices and ensure that the manufacturing facilities are GMP compliant.
