A Worldview of Your Global Market Clearance Strategy: Considerations in Developing a Robust Strategy

| 01 October 2008

Due to the medical device industry's global nature, manufacturers typically design and develop their products to meet the clearance requirements of the many countries in which they intend to market their products. Because regulations and market size vary by country and by product, the impact of these requirements on device development programs may not be readily apparent. Therefore, it is necessary to understand and apply country-specific requirements to maximize development investment. A global market clearance strategy (MCS) is central to your development and commercialization plans and overall business planning. A global MCS, together with a marketing strategy, should identify which markets are most lucrative and the order in which they should be entered, and establish the regulatory burden associated with target markets. It should also include pipeline indications, if any, for follow-on development and product expansion.


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