Combination Products and Asia Regional Medical Device ...
Combination Products and Asia Regional Medical Device ...
Combination Products and Asia Regional Medical Device ...
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<strong>Combination</strong> <strong>Products</strong><br />
<strong>Combination</strong> products<br />
• One item composed of two or more products that are<br />
subject to different regulatory regimes<br />
• Two or more differently regulated items that must be<br />
used together to achieve the intended outcome<br />
• Often, but not always, packaged together<br />
• Labelled for required use together<br />
• Often offer unique therapeutic advantages<br />
• A regulatory challenge for regulators <strong>and</strong> industry<br />
Source: S. Alpert, M.D., PhD. (Medtronic Corp.); <strong>Asia</strong>n Harmonization Working Party, Seoul, Sept. 2006, <strong>and</strong> US FDA (adapted)<br />
18-Oct-06<br />
APEC Tokyo 2006 <strong>Combination</strong> <strong>Products</strong> <strong>and</strong> <strong>Asia</strong>n Harmonization; M. Gropp<br />
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