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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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MedTech Insights Global Medical Device Statistics, Facts &
There are an estimated 2 million different kinds of medical devices on the world market, grouped into more...
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EU MDR Compliance Medical Device Regulations and Registration Process
Finland is an EU Member State, so medical devices are primarily regulated under the EU MDR/IVDR, alongside national legislation under...
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EU MDR Compliance Medical Device Regulations and Registration Process
Denmark has no separate national approval system for medical devices. If a device carries valid CE marking under EU MDR...
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EU MDR ComplianceRegulations Medical Device Regulations and Registration Process
Sweden is an EU Member State. That means medical devices here fall under EU MDR (Regulation (EU) 2017/745) and IVDR...
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Thai FDA Compliance Thailand Medical Device Regulations and Registration
Thai FDA Medical Device Registration covers three separate routes. Class 1 devices go through Listing, Class 2 and 3 through...
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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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US FDA Compliance Modernization of Cosmetics Regulation Act of
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was enacted on December 29, 2022. It came as part of...
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Pharmaceuticals InsightsUS FDA Compliance Pharmacovigilance of Biologics in the USA
Pharmacovigilance plays a vital role in ensuring the safety and efficacy of biologics, which are complex therapeutic agents derived from...
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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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