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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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Regulatory Contract Staffing in Mexico for a Leading Medical Device Manufacturer

Regulatory Contract Staffing in Mexico for

Artixio, a trusted player in the regulatory and commercial arena, provided contract staffing solutions to a global leading medical device manufacturer....

January 4, 2026
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Medical Device Regulations and Registration Process in Mexico

Medical Device Regulations and Registration Process

Before entering the Mexican market, medical devices need Registro Sanitario, or Sanitary Registration. Recently, regulatory simplification and a broader abbreviated...

August 9, 2026
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Notice of Operation: Essential Pre-requisite for registration of products with COFEPRIS, Mexico

Notice of Operation: Essential Pre-requisite for

A Notice of Operation in Mexico, or Aviso de Funcionamiento en México, is a document that must be filed with...

January 10, 2026
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Mexico Cosmetics Labeling & GMP for COFEPRIS Compliance in Mexico

Mexico Cosmetics Labeling & GMP for

Normal cosmetic products do not need to be registered before entering the market. But companies have the responsibility to make...

June 1, 2026
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