Global Regulatory Strategy and Country Reports

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 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 (now IMDRF) 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.

Our regulatory strategy reports for specific countries

Emergo 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 Regulatory Pathway reporting service, we provide the following information on individual medical device markets:

• Regulatory Background: Overview of a specific market’s regulatory environment
• Product Assessment: Assessment of whether a product qualifies as a medical device for a particular market
• Device Classification: Assessment of how your device will be classified in each of your chosen markets
• In-Country Representation: Identification of which markets require local regulatory representation
• Registration Requirements: Overview of documentation required for submission of a device registration application
• Labeling Requirements: Identification of device labeling, as well as translation requirements
• Costs: Estimation of costs associated with initial and ongoing regulatory compliance
• Timelines: Assessment of how long your device registration process may take in each of your chosen markets using the best information available
• Regulatory Roadmap: Overviews of steps to regulatory compliance
• Post-market Requirements: Identification of post-market obligations you’ll have in terms of surveillance and vigilance in each of your countries of interest

Additionally, Emergo can develop reports customized to meet exact client specifications.

Please contact us for further information on our Regulatory Strategy consulting services.