Thai FDA Registration

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:

  1. Pre-market control of the manufacturer, on the product, and on advertisment
  2. Post-market control: regular checks of the previously controlled facilities and products Market
  3. Surveillance: for consumers safety after the product has been marketed
  4. Consumer Education: check wehther the provided information are sufficient and accurate
  5. Technical support and cooperation with other agencies (e.g. seminars organized or attended to by the FDA)

FOOD REGISTRATION

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)
    • HACCP

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

in Thai FDA the Drug Control Division is responsible for release of certificates.

How to register drugs in Thai FDA

There are 4 kind of drugs in Thailand: New drugs, New generic drugs, Generic drugs and Traditional drugs. Every license has slight difference in requirements and procedures.

Process of drug registration in Thai FDA is in three steps: first is about business place (warehouse), staff and responsible pharmacist; second is about manufacturer (GMP and in some cases physical inspection of the venue); third, the product registranio itself.

Generally speaking, in order to apply for a drug registration following documentation is required:

  • Fulfilled application form
  • Permit to manufacture or import drug sample
  • Product sample
  • Pharmacological and toxicological study
  • Clinical trials, safety and efficacy study
  • Detailed Product formula
  • Drug literature
  • Detailed labeling and packaging
  • Legalized (by the authorized officer) and apostilled by the Thai Embassy certificate of free sale (in case of imported drug)
  • Manufacturing method
  • 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
  • Packaging
  • Storage conditions
  • 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.

Summary
Thai FDA product registration
Service Type
Thai FDA product registration
Provider Name
Siam Trade Development,
Two Pacific Place, 142 Sukhumvit Road, 14th floor, Suite 1406,Bangkok,10110,
Telephone No.+66830314030
Area
Thailand
Description
Thai FDA registration is required for foods, drugs, psychotropic and hazardous substances, narcotics, medical devices, volatile substances, cosmetics. We can register your products in Thai FDA