Activity

  • There are ISO standards that are used by companies for launching any medical device in any country that doesn’t have their medical standards or if they are not clear enough. The countries that have their own medical regulation of medical devices prefer following them particularly in their country. There is also a part that results in non agreement in global regulatory standards because it gets an investment in the country for the cost of the approval of the medical devices when it comes to developed countries. In addition, the country itself has invested much to comeup with these standards after many man and money power that would be likely to recover from companies that need approval and sale in that country. It won’t be easy to get transferred from those to new global regulations. Some of them may not agree due to superiority issues. Now thinking about the safety prospect there was seen flaws in European standards that made US FDA more reliable. In such cases having different regulatory standards are beneficial or act as a backup. However, investment of all the money, brains and datas globally may lead to a fantastic and strong regulatory standards of medical devices. But there are least chances of global regulations where countries can’t even agree on each others prospective.