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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 ComplianceRegulatory Updates Mexico COFEPRIS Updates on Medical Devices,
Overview of December 2025 Regulatory Changes in Mexico Low risk Medical Device listing, application criteria as per the Q&A document...
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AI TechnologyMFDS Compliance Orphan Drug Designation in South Korea
Orphan Drug Designation (ODD) is regulated by Ministry of Food and Drug Safety (MFDS) in South Korea under the Pharmaceutical...
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Case Study Prioritizing Genes from Publicly Available GWAS
Artixio has developed an artificial intelligence based solution generating a list of prioritized genes using a custom developed scoring matrix....
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CDSCO ComplianceMedTech Insights CDSCO Simplifies Subsequent Importer Process for
India’s regulatory authority, the Central Drugs Standard Control Organization (CDSCO), has published an important update to streamline subsequent importer applications...
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Pharmaceuticals InsightsThai FDA Compliance Thai FDA Pharmaceutical Regulations & Registration
Before placing any pharma product in the market, companies must secure marketing authorization. This applies whether the product is imported...
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Pharmaceuticals InsightsUS FDA Compliance US FDA Pharmacovigilance Requirements For Drugs
Pharmacovigilance is a cornerstone of drug regulation in the USA, playing a crucial role in ensuring the safety and efficacy...
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MedTech InsightsUS FDA Compliance Q-Submission Meetings for Medical Devices with
Bringing a medical device to the US market involves more than just paperwork — the FDA often expects early discussions...
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US FDA Compliance US Agent Responsibilities for FDA Compliance
Foreign manufacturers planning to sell drugs, devices, food, or cosmetics in the US must appoint a US Agent. The FDA...
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