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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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EU Medical Device Recognition in India

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...

October 15, 2026
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Qurious RI DMF Database Module for Global DMF and CEP Status Tracking

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...

October 13, 2026
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UK AI Medical Device Regulation and Reforms

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...

October 12, 2026
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QuriousRI Nitrosamine Assessment Tool for Global Regulatory Compliance

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...

October 8, 2026
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Medical Device Regulations and Registration Process in Saudi Arabia

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...

September 9, 2026
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SFDA Cosmetics Regulations in Saudi Arabia for Notification and Import

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...

October 15, 2026
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Cosmetics Regulations in Thailand: Notification, Requirements & Costs

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...

June 1, 2026
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How to Choose a Regulatory Consultant in Thailand

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....

October 15, 2026
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Combinational Drugs Approval Process in Thailand

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...

January 30, 2026
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Thailand Government Schemes for Pharma & Medical Device Industry

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...

March 25, 2026
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Cosmetics Regulations & Registration Process in the Philippines

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...

June 7, 2026
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Medical Devices Regulation With PFDA In Philippines

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...

January 26, 2026
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FDA PMA eSTAR Draft Guidance: What Sponsors Need to Know

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)...

October 1, 2026
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FDA CDRH Annual Reporting Requirements for Laser Products

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...

September 24, 2026
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Veterinary Pharmaceuticals Regulations and Registration in USA

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...

July 16, 2026
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Cosmetics Regulations & Compliance Process in the USA

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...

September 7, 2026
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Medical Device Regulations & Registration In Taiwan

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...

February 13, 2026
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Pharmaceutical Drug Registration Requirements In Taiwan

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...

February 13, 2026
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Taiwan FDA Cosmetics Regulations & Notification Process

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....

September 7, 2026
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TFDA Pharmaceutical Drugs Regulation in Taiwan

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...

February 3, 2026
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