THAI FDA PRODUCT REGISTRATION – background
Thai FDA registration is required for the following products on the Thai market (manufactured or imported): foods, drugs, psychotropic substances, narcotics, medical devices, volatile substances, cosmetics and hazardous substances.
Thai FDA registration is based on five different sorts of control:
- Pre-market control of the manufacturer, on the product, and on advertisment
- Post-market control: regular checks of the previously controlled facilities and products Market
- Surveillance: for consumers safety after the product has been marketed
- Consumer Education: check wehther the provided information are sufficient and accurate
- Technical support and cooperation with other agencies (e.g. seminars organized or attended to by the FDA)
FDA in Thailand implements by enforcing the Food Act 2522 and controls the quality and safety of food by:
implementing food standards, specifications and hygienic and labeling requirements
Regulating production and import of food products
Controlling advertisement and packaging
Regulating epidemiological studies. Thai FDA can release the following certificates:
- Free-sale Certificate
- Sanitary Certification
- GMP (through third party Certify Bodies)
How to register food products in thai FDA
The process is in two steps; Registered Business Place must be approved (by physical inspection) before the application to manufacture or import the product.
If you are searching for a skilled team fo your Food Products Registration in Thai FDA, don’t hesitate to contact us.
DRUG REGISTRATION IN THAI FDA
How to register drugs in Thai FDA
Fulfilled application form
Permit to manufacture or import drug sample
Pharmacological and toxicological study
Clinical trials, safety and efficacy study
Detailed Product formula
Detailed labeling and packaging
Legalized (by the authorized officer) and apostilled by the Thai Embassy certificate of free sale (in case of imported drug)
In-process control with the relevant acceptable limits
Active principles specifications eccipients ingredients with the corresponding control methods in details
Finished product specification with the corresponding control methods in details
Certificate of analysis of active ingredient(s)
Drug analytical control method
Stability studies of the finished product
A certificate of GMP (in case of imported drug)
FDA drug registration In Thailand has unlimited validity.
We can register your drug products in a timeframe from 6 to 9 months, and give additional services such as license holding, storage and dedicated pharmacist.
Contact us if you want to import drugs into Thailand.
MEDICAL DEVICES REGISTRATION IN THAILAND
About Medical Devices Registration in Thai FDA we kindly suggest you to browse the dedicated page HERE
We can get FDA license for your Medical Devices in a timeframe from 1 to 4 months, and give additional services such as license holding, storage and delivery (3PL).
Contact us if you want to import Medcial Devices into Thailand.
DIETARY SUPPLEMENTS REGISTRATION IN THAILAND
About Dietary supplements Registration in Thai FDA we kindly suggest you to browse the dedicated page HERE
We can register in Thai FDA your Dietary Supplement products in a timeframe from 3 to 6 weeks, and give additional services such as license holding, storage and delivery (3PL).
Contact us if you want to import Dietary Supplements into Thailand.