GMV 0.00% 3.9¢ g medical innovations holdings limited

News: GMV G Medical Innovations Holdings Files For Offering Of 1.4 Million Adss, page-529

  1. 662 Posts.
    lightbulb Created with Sketch. 332
    Found this in a research article from 2012. Obviously a bit old, but still has a few interesting insights:

    Wang Xiaochuan, CEO of Sundia Meditech, explains that there are 3 reasons why the approval process is so long in China. Firstly, he believes that the Zheng Xiaoyu execution incident has rendered people afraid of making mistakes. As a result, standards have been implemented to be as close to internationally accepted as possible. Thus, rather than a gradual evolution of the regulatory process, the standards have become too strict without allowing companies and regulatory agencies to develop appropriate. As a result, clinical trial approval times become longer while costs for research rise. Secondly, he believes that the approval instructions for medical devices are unclear and opaque; oftentimes applications need to be revised or redone, again wasting considerable time. Lastly, Wang Xiaochuan finds that political influence also affects the long approval time. While the average time to enter a clinical trial is 150-200 days in China, shorter times can be achieved through political connections. For example, an interview with a pharmaceutical subsidiary of a large domestic oil and gas corporation revealed that the time to enter a clinical trial is “usually dependent on how influential or close you are to the review board” (Koh, 2011). This signals not only the influence of politics on clinical trial approval, but also more significantly their influence on the ultimate success of medical devices. According to Xiaochuan, government support is also increased heavily for products that are able to proceed to the clinical trial stage of approval. From this perspective, clinical trials serve as a gateway for medical device production and manufacturing.



 
watchlist Created with Sketch. Add GMV (ASX) to my watchlist

Currently unlisted public company.

arrow-down-2 Created with Sketch. arrow-down-2 Created with Sketch.