Product Registration Services in Thailand for Life Sciences

Getting Thai FDA approval isn’t just paperwork—it’s strategy. We help life sciences companies get licensed, registered, and launched in Thailand.

Services We Offer

Thailand Product Approval Services – From Dossier to Thai FDA Clearance

Launching a product in Thailand’s life sciences market? Artixio provides end-to-end product registration services in Thailand, helping you meet Thai FDA expectations without delays. Whether you need support for MAH registration services Thailand, import licensing, or technical documentation, our team ensures full alignment with the Thai FDA registration process.

Whether it’s product registration services in Thailand, MAH registration, or support with import licenses, we tailor our approach to your product type. We stay close to the changing Thai FDA registration process, so you don’t miss a detail. If you’re after Thailand FDA licence consulting or hands-on help with life sciences registration services, we’re here to back you up—without the jargon.

Thai FDA, Thailand

The primary regulatory authority responsible for product registration in Thailand is the Thai Food and Drug Administration (Thai FDA). It oversees the regulation of pharmaceuticals, medical devices, cosmetics, food, and other health-related products.

Who Needs Product Registration in Thailand?

Whether you’re importing a medical device, exporting cosmetics, or registering dietary supplements in Thailand, TFDA product registration is mandatory. Without it, products can’t be sold, distributed, or marketed legally. Artixio supports global life sciences companies with complete registration and licensing solutions tailored to Thai FDA expectations.

Life Sciences Product Registration Process in Thailand

Each product category—medical device, cosmetic, nutrition, biologic, or veterinary—has different submission needs. Here’s how we guide you:

Identify applicable regulations based on product category.
Compile technical data, specifications, and manufacturing details.
Submit complete application and supporting documents to Thai FDA.
Thai FDA reviews the submission for regulatory compliance.
Thai FDA may inspect manufacturing facilities or products.
Approval granted, and product is officially registered.
Monitor product performance and address any reported issues.

MAH Registration Support in Thailand

Foreign companies without a local presence need a Marketing Authorization Holder (MAH) in Thailand. Artixio acts as your trusted MAH, ensuring local regulatory accountability, smooth importation, and fast-track approvals with Thai FDA. Our consultants are experienced in the end-to-end lifecycle — from classification and licensing to post-market updates and renewals.

Choose Artixio for Product Registration in Thailand

Specialized knowledge of Thailand’s life sciences product regulations.
Local and regional consultants to avoid delays
Personalized strategies for successful product launches and compliance.
Strong connections with regulatory authorities for faster results.
ISO 9001:2015 certified processes

FAQs

What challenges are faced during product registration in Thailand?

Common challenges include understanding the local regulatory nuances, navigating language barriers, and managing local testing requirements. Artixio helps address these issues with localized expertise.

Are there specific approval pathways for medical devices versus other products in Thailand?

Yes, medical devices are subject to a different set of regulations under the Thai FDA’s medical device division, with additional testing and clinical data requirements compared to pharmaceuticals or cosmetics.

Do I need a Thai distributor to register my product?

Yes, in most cases, the Thai FDA requires that you appoint a local distributor or authorized representative for communication and documentation purposes.