A brief commentary in Medical Design Magazine last year suggested the time was right for a sort of ISO FDA, a worldwide organization that would regulate the introduction of medical devices and give all device makers in all countries the same rules to work by. The more you think about it, the more sense it makes because there are dozens of such organizations around the world, each with its own mountain of regulations. Admittedly, there is a positive aspect to many regulations: keeping track of changing rules provides job security for thousands at device companies and consultancies. It’s not value-added work, but it is necessary.

Two news items in this newsletter deal with changing regulations. In Canada, Bill C-51 proposes far reaching changes to the country’s food and drug laws. The other item, from Hong Kong, shows some forward thinking and suggests that reams of China-only regulations might not be necessary if your product meets some U.S., Europe, or Japanese regs. Say what you will about Chinese quality control, but at least they are going in the right direction—toward an ISO-based concept of “your rules are our rules.”