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Apart from the member countries of the EC, the routes to market can vary widely from country to country . 
In general terms the time, costs, data collation, compliance evidence and resources necessary to attain regulatory approvals tend to be by-passed in business, product development and marketing plans. 
We have included indicative steps to market in EC, US,  and Canada. Please call for assistance for any other country e.g. Japan and China.

 

REGULATORY AFFAIRS NEWS

ISO

ISO announce survey for ISO 13485 review in preparation for revision of 13485 and 14969:2004 guidance document. Note: Must be completed by 31 August 2011. Conduct Survey

EC

ISO 14155:2011 Updated Standard published for Clinical Investigations.

US

FDA Publishes new guideline Using Human Factors & Useability Engineering Get Guideline

FDA publishes next steps in 510k process. Get Report

FDA launches new "Basics For Industry Website" and pledges better communication with industry. Access Site

FDA Provides New Process Validation Guidance Access Document

 

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