Hello,
As per Medical Device Rules 2017, the MD that are being imported into India should have manufacturing site address.
For more details, please visit Doc No.: CDSCO/FAQ/MD/01/2018 i.e. "Frequently Asked Questions on Medical Device Rule, 2017".
The FAQ appears on
http://www.cdsco.nic.in/writereaddata/FAQ%20MDR_2017.pdf
.
------------------------------
PURVI GORADIA
Manager Regulatory Affairs
Mumbai
India
------------------------------
Original Message:
Sent: 08-Mar-2018 06:51
From: James Bonds
Subject: India Labeling Requirements
My firm is trying to import a device into India. It is a US and EU Class 1 sterile bandage (think band-aid). We are based in the US and have design control and all product liability, but the device is manufactured under contract in another country. India (through our distributor) is insisting that the address of the actual manufacturing site be listed. We are resisting, because the manufacturing site takes no legal responsibility or liability for the device other than meeting our quality and other contractual requirements. In previous companies I have worked for, the same device was manufactured in multiple locations worldwide and only had the corporate office name and address on the labeling, not the actual manufacturing site. Has anyone encountered this issue, and how was it addressed?
Thanks,
James