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Safety Alert & Recalls/ Review Reports/ Package Inserts etc.

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About PMDA

About PMDA

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Safety Alert & Recalls/ Review Reports/ Package Inserts etc.

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In Vitro Diagnostics

Reviews and Related Services

In Vitro Diagnostics

日本語ページはこちら

Links to major regulatory information of In Vitro Diagnostics.

Regulations and Notifications

Marketing Approval

Points to Consider When Applying for Marketing Approval of In Vitro Diagnostics[299.86KB]

November 21, 2014 PFSB/ELD/OMDE Notification No. 1121-16

Applications for Marketing Approval of In Vitro Diagnostics[143.88KB]

November 21, 2014 PFSB Notification No. 1121-15