The pathway from design to commercialisation for a new medical device can be complex and full of uncertainty. A specific product claim or intended use can lead to varying product classification and registration path due to differences in laws and regulations of different markets. A regulatory strategy will help you to bring into consideration the various regulatory issues and put together a plan that will bring your medical devices into the target markets.
In some countries, product classification principles are standardised across both IVDs and general medical devices but not for some. One good example is the U.S. FDA.
How about those countries, which have product classification routes designed differently for the two main categories of medical devices such as Singapore?Today, we shall discuss about the classification of a general medical device!