Product Registration in Thailand
Secure Your Certificate of Product Registration (CPR)
Thailand FDA Product Registration ensures the quality and safety of regulated goods intended for distribution and consumption in the Thai market.
What is a Certificate of Product Registration?
A certificate of product registration refers to the official approval issued by the Thai Food and Drug Administration (FDA) for regulated products before they can be manufactured, imported, or sold in the market. It verifies that products meet safety, quality, and labeling standards to protect consumers from unsafe or misleading goods
Who Needs to Register?
Product registration is mandatory for manufacturers, importers, and distributors of regulated products to ensure compliance with safety and quality standards.
What You Need for a Thai FDA Product Registration?
Specific requirements depends on the risk level of your product category. The higher the risk factor, the more stringent the application process will be.
- Product information (name, ingredients, composition, shelf life)
- Labeling (must be in Thai language and comply with FDA regulations)
- Valid Establishment License (whether Importing or Manufacturing)
- GMP Certification
- Free Sale Certificate (for importers)
- Power of Attorney
Pro Tip: Ensure all foreign documents are notarized and legalized by the Thai Embassy in your home country before sending them to our Bangkok office.
Registration vs Notification
Based on Thailand’s risk-based classification, some products may only need a notification instead of a registration. Depending on your the category and intended health claims, your application will follow one of two distinct administrative tracks within the electronic Skynet System.
Product Notification
Reserved for lower-risk categories like General Cosmetics and General Food. The process is faster and focuses on verifying that ingredients meet ASEAN and Thai standards.
- Approved in 1–2 weeks
- Ingredient-focused review
- No physical board review required
Product Registration
Required for High-Risk Medical Devices, Controlled Food, and Drugs. This is a technical evaluation of the product’s safety, stability, and efficacy.
- 4–12 month approval cycle
- Full Dossier (CSDT) required
- Mandatory board evaluation
Why Are Applications Rejected?
Avoid these three common pitfalls that delay market entry in Thailand. With Emerhub, we can help ensure that you have the correct requirements to register your products.
Formula Mismatch
The ingredients declared in the dossier do not match the laboratory test results from the Thai FDA samples.
Unapproved Claims
Using “medical” or “therapeutic” claims on food or cosmetics labels without supporting drug-level data.
Expired Source Documents
Submitting ISO or GMP certificates that expire during the FDA’s 6-month review period.
Don’t risk your market entry on administrative errors.
Emerhub’s technical team conducts a comprehensive pre-submission audit to verify your formulas, claims, and certificates against current Thai B.E. standards. We ensure your application is “Right the First Time,” preventing costly delays and ensuring a smooth path to approval.
With 14+ Years of Experience and Vast Network of Professionals
Product Registration Made Simple with Emerhub
Common FAQs About Product Registration in Thailand
Certificates for Controlled Food and Medical Devices are typically valid for 5 years. Cosmetic notifications are usually valid for 3 years. All can be renewed through the Skynet portal.
It depends. In cosmetics, different shades of the same product can often be grouped. In medical devices, a “family” of products can be registered under one CSDT if they share the same intended use and manufacturing process.
No. It is primarily required for Specifically Controlled Foods (like supplements) and high-risk Medical Devices. General cosmetics and standardized foods are usually document-based only, though the FDA reserves the right to request testing.
The FDA issues a “Query” via Skynet. You typically have 30 days to respond. Emerhub’s advisors handle these queries directly with the officers to ensure the response meets their technical expectations.
Schedule a call with an Emerhub consultant in Thailand
Tell us about your plans. Schedule a free, no-obligation consultation with our team of experts. We’ll reach out to discuss your needs and how we can help you register your products with the Thai FDA.
Email Us
info@emerhub.com
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+66 92 554 5444
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20th Floor, United Business Center II Building, 591 Sukhumvit 33 Alley, Khlong Tan Nuea, Watthana, Bangkok 10110, Thailand