Regulatory Strategy
Anyone who develops and wants to sell a medical device must make a careful decision about the target markets.
Regulatory Requirements Importance
Anyone who develops and wants to sell a medical device must make a careful decision about the target markets. In addition to commercial decision criteria, such as revenue and market share, regulatory requirements are also decisively important. Those who do not take these into account run the risk of exploding costs and time in product development and the product may not reach the market at all.
There are several factors to consider when deciding which market to enter with a medical device. Market strategy should not be established without regulatory considerations, and should not be only driven by economic factors like revenue and market share. The attractiveness of a market needs to be weighed with regulatory requirements in mind as the time, cost, and complexity of getting and maintaining a medical device approval cannot be underestimated. The regulatory strategy should be set up in the early phases of the product development process, as it impacts the market launch, marketing activities, and therefore the business.
Why it is important?
Medical device manufacturers that fail to account for regulatory compliance issues early in the process are often met with unexpected surprises. Efforts to achieve compliance with regulatory requirements after the product development process has been completed can be a significantly more complex undertaking, and can even cause further product development efforts with lengthy delays.
How we can Help You?
Rico solutions manages the registration of medical devices all over the world. Our medical device professionals and specialists are experts regarding national requirements applicable to medical devices in all key target markets. As such, we know the critical questions you have to ask to identify the gaps in your planning of an effective regulatory strategy.
