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 />
GHTF<br />
Purpose (cont’d):<br />
“.... the primary way in which this is accomplished is<br />
via the publication <strong>and</strong> dissemination of harmonized<br />
guidance documents on basic regulatory practices.<br />
These documents can then be adopted / implemented<br />
by member national regulatory authorities ...”<br />
• GHTF guidance substantially adopted in<br />
Australia, Canada, EU, <strong>and</strong> Japan<br />
Source: GHTF<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 />
47
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