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Compliances - FDA

FDA Compliance Insights

This page includes our articles on regulatory requirements issued by different FDA authorities, including the US, Thailand, Saudi Arabia, Taiwan, and Philippines. The content covers registration processes, compliance expectations, and notable regulatory updates across regulated product categories.

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COFEPRIS Reliance Pathway: Mexico Regulatory Update 2025

COFEPRIS Reliance Pathway: Mexico Regulatory Update

Modernization of the COFEPRIS Regulatory Framework: Introduction of a Reliance Pathway Diario Oficial de la Federación (DOF) published a new...

January 3, 2026
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Thai FDA Updates Medical Device Advertising Rules – Jan, 2025

Thai FDA Updates Medical Device Advertising

The Food and Drug Administration Announcement RE: Determination of Criteria, Conditions, and Requirements for Approval, Issuance of License, and License...

February 17, 2026
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In Vitro Companion Diagnostics Regulations In Australia

In Vitro Companion Diagnostics Regulations In

A Companion Diagnostic (CDx) is an in-vitro diagnostic (IVD) medical device that plays a critical role in personalized medicine treatment...

February 16, 2026
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CDSCO Medical Device Approval Cost & Fee Structure

CDSCO Medical Device Approval Cost &

Central Drug Standard Control Organization (CDSCO) is the regulatory authority that regulates Medical Devices in India. It is important to...

February 10, 2026
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