Planning for market entry without an understanding of the regulatory costs, timelines and hurdles is like betting on a hand in poker without looking at your cards. There are numerous risks involved in entering a new medical device market, including costs, potential delays and market interruptions imposed by local regulators.
Most medical device market regulators exercise controls over products imported and sold in their countries. Regulatory costs and controls can vary widely from country to country, and understanding how to enter a particular market requires insight into the unique medical device regulations affecting that market. Regulatory compliance in one market may cost 3-5 times more than compliance in a similar market.
While great strides have been made toward regulatory harmonization in recent years through Global Harmonization Task Force initiatives (and their corresponding affiliates) and development of common economic trading regions, most countries still maintain medical device regulatory systems distinct enough to require analysis on a market-by-market basis to fully appreciate their compliance requirements.
Emergo Group leverages an extensive global network of consultants as well as industry and regulatory contacts to provide clients with information to assess the regulatory requirements for every significant medical device market in the world. Through our Global Regulatory Overview Report service, we provide the following information on individual medical device markets:
Additionally, Emergo Group can develop reports customized to meet exact client specifications.