Tuesday, July 15, 2014

Medical device clinical trials to be made mandatory in India

Medical device clinical trials are changing in India.  Recently announced, according to the Deccan Herold, clinical trials will follow the same lines as those of vaccines and medications.  Those devices which came out between the years of 1989 and 2005 will also have to undergo clinical trials.

Announced July 3, the following will now need to have clinical trials: disposable hypodermic syringes and needles, cardiac stents, drug eluting stents, catheters, bone cements, heart valve, intra-ocular lenses, intra-venous cannulae, orthopaedic implants and internal prosthetic replacements.

Industry representatives will meet with governing officials to clarify questions they have.  Many of the clinical trials needed for products that have been on the market for years.  They also want to discuss the differences in medical devices and drugs and how different regulations are needed to better suit the products on the market.

This September in Shanghai, we'll have a special round table focus lead by Jimmy Lu, Senior Clinical Specialist, Roche Diagnostics, China to look at medical device clinical trials in a different country - China.  Sign up to join us at the roundtable  How to Conduct Medical Device Clinical Trial in China when you register to join us at Partnerships in Clinical Trials Asia this September 16-18 in Shanghai, China.   Find out more about this roundtable and this year's program by downloading the brochure. As a reader of this blog, when you register to join us and mention code XP1975BLOG, you'll save 20% off the standard rate. 

Do you think that medical devices and drugs/vaccines should have the same standards when conducting clinical trails?  Why or why not?




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