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<strong>Combination</strong> <strong>Products</strong><br />

How can APEC LSIF help these regional<br />

medical device regulatory harmonization<br />

initiatives<br />

Recommend to Ministers to promote the adoption of<br />

GHTF guidance documents in APEC member<br />

economies<br />

• consistent with local public health priorities<br />

• in stages, from basic regulatory controls to more<br />

advanced <strong>and</strong> intensive controls as resources<br />

permit<br />

• consider regional “pooling of competence” in<br />

conformity assessment<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 />

82

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