Association Of Indian Medical Device Industry (AIMED) : International
Regulatory Update
SAFETY OF REPROCESSED
MEDICAL DEVICES MARKETED FOR SINGLE-USE - ADOPTION OF SCIENTIFIC
OPINION
The European
Commission's independent Scientific Committee on Emerging and Newly
Identified Health Risks (SCENIHR) has
recently published its opinion on the safety of reprocessed medical
devices marketed for single-use. They say; A single-use medical device
(SUD) is a device intended to be used once only for a single patient.
Examples of SUDs are single-use syringes and needles, catheters and
breathing tubes...
J&J Sees
Fast-Growing Device Market : Plans 80 Regulatory Submissions For New
Devices
*Plans 80 regulatory
submissions for new devices
Johnson & Johnson (JNJ.N)
sees itself competing in a faster-growing segment of the medical
device market and plans about 80 "significant" regulatory submissions
for its largest unit in the next two years...
Planning Commission Examining Proposal For Rs 350 Cr Dedicated Medical
Devices Park In Gujarat
Planning Commission is
likely to give the in-principle approval soon for the proposal by the
Department of Pharmaceuticals to set up a dedicated greenfield Medical
Devices and Equipment Park worth around Rs 350 crore near Sanand in
Gujarat.
Gujarat FDCA To Set Up Dedicated Testing Lab For Medical Devices In
Baroda
The Gujarat Food and
Drug Control Administration (FDCA) is planning to set up a new
laboratory dedicated for testing quality of medical devices in the
premises of its existing drug testing laboratory at Baroda.
Trivitron Inks Pack With IIT Madras To Set Up Biomedical R&D Centre In
IIT Campus
The Chennai-based
medical devices manufacturing company, Trivitron Health care Ltd, has
signed a Memorandum of Understanding with IIT Madras to set up a
Centre of Excellence for Biomedical Research & Development and Design
in the IIT Madras which would offer own design, innovative and cost
effective medical technology solutions to India and other emerging
markets. |