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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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Cosmetics Regulations & Registration Process in South Africa (SAHPRA & Compliance Guide)

Cosmetics Regulations & Registration Process in

When a product is classified as a medicine or a borderline product, it becomes a hurdle to enter South Africa's...

May 19, 2026
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Cosmetics Regulations & Registration Process in the Philippines (FDA Notification Guide)

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...

May 19, 2026
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Cosmetics Regulations & Registration Process in Vietnam (ASEAN Notification Guide)

Cosmetics Regulations & Registration Process in

The Vietnam cosmetic launch may be postponed due to minor problems. This may be because the Certificate of Free Sale...

May 19, 2026
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Cosmetics Regulations & Registration Process in the European Union (EU CPNP Compliance Guide)

Cosmetics Regulations & Registration Process in

Anyone planning to put cosmetics on the EU market must notify the products in accordance with Regulation (EC) No 1223/2009....

May 19, 2026
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Thai FDA Updates Medical Device Advertising Rules – Jan, 2025

Thai FDA Updates Medical Device Advertising

The Food and Drug Administration Announcement RE: Determination of Criteria, Conditions, and Requirements for Approval, Issuance of License, and License...

February 17, 2026
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Thailand Medical Device Import License Regulations

Thailand Medical Device Import License Regulations

If you're looking to import medical equipment into Thailand, you'll need to get a Thai FDA license first. There’s paperwork, licenses,...

February 17, 2026
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Nutraceutical Regulations & Registration Process in Thailand

Nutraceutical Regulations & Registration Process in

Thailand, known for its rich cultural heritage and breathtaking landscapes, is also a significant player in the global nutraceutical industry....

February 17, 2026
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Thai FDA Regulations of Food Manufactured or Imported In Thailand

Thai FDA Regulations of Food Manufactured

Thailand’s Ministry of Public Health and the Thai FDA handle most of the food regulation work. They keep an eye...

February 17, 2026
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Biologics and Biosimilars Regulations, Registration Process in the USA (FDA)

Biologics and Biosimilars Regulations, Registration Process

The size of the U.S. biosimilars market, estimated at USD 6.73 billion in 2021, is expected to increase by USD...

February 2, 2026
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Pharmacovigilance of Vaccines in the USA (US FDA)

Pharmacovigilance of Vaccines in the USA

Pharmacovigilance is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other...

February 5, 2026
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US FDA Regulation of Nitrosamines In USA

US FDA Regulation of Nitrosamines In

Nitrosamines are a class of compounds known for their potent carcinogenic effects. Their discovery in pharmaceuticals has sparked significant concern...

February 15, 2026
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US FDA Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

US FDA Modernization of Cosmetics Regulation

On 29 December 2022, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) became part of the Consolidated Appropriations Act,...

May 12, 2026
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