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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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Regulatory Updates EU Medical Device Recognition in India
India now allows eligible medical devices approved in the European Union to be considered for a waiver from submitting clinical...
Regulations Qurious RI DMF Database Module for
Qurious RI’s DMF Database module offers a platform for tracking evidence-based, audit ready DMFs and CEPs status for APIs and...
Regulatory Updates UK AI Medical Device Regulation and
In the UK, AI medical devices fall under the Medical Devices Regulations 2002 (UK MDR 2002). The Medicines and Healthcare...
Regulations QuriousRI Nitrosamine Assessment Tool for Global
QuriousRI’s Nitrosamine assessment tool is part of global regulatory strategy platform offering a single platform for evidence-based, audit-ready decision support...
Saudi FDA Compliance Medical Device Regulations and Registration Process
Entering the Saudi medical market requires regulatory approval. Before any medical device reaches hospitals or patients, it must obtain a...
Saudi FDA Compliance SFDA Cosmetics Regulations in Saudi Arabia
Cosmetics are huge in Saudi Arabia right now. The government is paying close attention to it. SFDA, which oversees beauty...
Cosmetics InsightsThai FDA Compliance Cosmetics Regulations in Thailand: Notification, Requirements
Cosmetic products entering Thailand, particularly imported skincare, personal care, and formulations of beauty products, tend to be delayed or held...
Thai FDA Compliance How to Choose a Regulatory Consultant
Thailand’s regulated health-product sectors, which include cosmetics, food, medical devices, medicines, and herbal products, are subject to specific regulatory requirements....
Pharmaceuticals InsightsThai FDA Compliance Combinational Drugs Approval Process in Thailand
The combinations in Thailand play a major role in marking the pharmaceutical development. Combinational drugs are basically fixed-dose combinations of...
Thai FDA Compliance Thailand Government Schemes for Pharma &
Pharmaceutical and Medical device industries in Thailand are growing to meet the increasing demand for healthcare needs. To speed up...
Cosmetics InsightsPFDA Compliance Cosmetics Regulations & Registration Process in
Cosmetic notification in the Philippines is frequently delayed because the labels are non-compliant with the regulations, the claims made are...
MedTech InsightsPFDA Compliance Medical Devices Regulation With PFDA In
In the Philippines, the medical device industry relies heavily on imports for its products. Whether these products are made...
Regulatory UpdatesUS FDA Compliance FDA PMA eSTAR Draft Guidance: What
On September 18, 2026, FDA's Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER)...
US FDA Compliance FDA CDRH Annual Reporting Requirements for
Manufacturers often assume that making a laser product means an annual FDA filing. That assumption is wrong. The obligation depends...
US FDA Compliance Veterinary Pharmaceuticals Regulations and Registration in
For veterinary pharmaceuticals to be sold in the U.S. market, they must be approved by the FDA Center for Veterinary...
US FDA Compliance Cosmetics Regulations & Compliance Process in
In the United States, cosmetic products and ingredients don’t need any pre-market approval. However, authorities may crack down on products...
Taiwan FDA Compliance Medical Device Regulations & Registration In
Medical devices regulations and registration process in Taiwan explained The market value of the medical device industry in Taiwan is...
Taiwan FDA Compliance Pharmaceutical Drug Registration Requirements In Taiwan
Taiwan’s pharmaceutical market was estimated $2.9 Billion in 2021 growing at the rate of 3% CAGR Taiwan’s market is dependent...
Taiwan FDA Compliance Taiwan FDA Cosmetics Regulations & Notification
Cosmetic notification in Taiwan is straightforward, but compliance issues usually appear later. This may be during import checks or inspections....
Pharmaceuticals InsightsTaiwan FDA Compliance TFDA Pharmaceutical Drugs Regulation in Taiwan
The pharmaceutical market is growing with the rise in pharmaceutical innovations in Taiwan. The Taiwan Food and Drug Administration (TFDA) is...