Basic Guide to Thai FDA Registration For Importers
The Entrepreneurs who desire to import the products into Thailand should know about Food and Drug Administration (FDA) Registration in Thailand beforehand. Especially, if you desire to import drugs, hazardous substances, medical supplies, food supplements, animal health products and cosmetics to this country, you need to apply to the Thai FDA license first because the application time frame varies are according to the type of product. For example, the estimated time to import cosmetics products can take 15 to 30 days. Basic medical equipment and toxic substances can take approximately 1 to 4 months. Food and medicinal products will take roughly 3 to 5 months.
FDA application for drugs:
The FDA has divided the drugs into up-to-date, basic medicines, traditional medicines, and veterinary medicines. Each species has its own set of requirements. Basic medicines are further divided into new drugs with labelled and without labelled. The Thai FDA issues drug licenses indefinitely.
Tips For Registration Drugs: follow ASEAN Harmonized Product on Pharmaceutical Registration Agreement. Conduct a review of a good registry assessment according to the standards WHO Good Review Practices: Guidelines for National and regional Regulatory Authorities and WHO Good Regulatory Practices in the Regulation of Medical Products
FDA application for medical devices:
Medical devices are inspected by a special department of the FDA. Medical devices are divided into three groups. The first group is IVD. The second group is Non-IVD.
Tips for Registering Medical Devices:
Completeness of documents such as ISO13485 or Coding and Name of Global Medical Device Nomenclature (GMDN) is a compilation of the names of various countries which is known to be used to describe and display medical devices accurately and precisely as products are used to diagnose, prevent, monitor, treat or mitigate human disease or injury.
FDA application for cosmetics:
There are two types of cosmetics depending on the ingredients which include Controlled Cosmetics: The FDA must be notified of a list of ingredients before it is released to the market. It usually takes 1 day. And, Special Controlled Cosmetics: if containing specially controlled ingredients, you must apply for a permit to use this product. In terms of duration, it could be taken up to a month.
Tips for Registering Cosmetics:
Create a PRODUCT INFORMATION FILE (PIF), which contains all product information, such as product safety information and the safety profile of each ingredient in the product, etc. kept at the place of business and must be handed over to the competent authorities upon request. Follow the basic rules of the production method/water. Imported cosmetic products (COSMETIC GOOD MANUFACTURING PRACTICE: GMP)
FDA application for hazardous substances:
There are four types of hazardous substances. The first type is the least dangerous, so the importation of this product does not require an application, but it is checked by special procedures.
The second type needs to be watched and controlled; You need to acquire registration certificates from FDA before any operations with this type of substance.
The third type also requires strict inspection and FDA certification.
Finally, the fourth type can be plants, animals, and substances that can endanger the environment. The production, importation and exportation of these substances are prohibited by law.
Tips for registrations hazardous substances:
Documents that entrepreneurs must submit for consideration of registration are:
- The label of the product to be released.
- Ingredients Formula – Must specify chemical name. In case that it is a trade name, there must be a document stating the chemical name of that trade name.
– Must specify formula with 100% complete ingredients
– Must specify the active ingredient (active ingredient) and function of every substance in the formulation.
– Ratio The key must be exactly as stated in the statement. Application for registration (Wor./SorThor. 1)
In case of this product imported from abroad, the ingredient formula document must be the original document issued and certified by a foreign manufacturer.
- Production process Packing and labeling
- Physical and chemical properties.
- Product Safety Data Sheet (SDS : Safety data sheet)
- Performance test results. (In the case of products that prevent insects and other animals / disinfectants and bleach products)
- Analytical results of important substances. (In case the product contains hazardous substances in
List of hazardous substances, 61 items that must be submitted for analysis of important substances)
- Certificate of Free Sales
FDA application for food:
If you want to import food, you have to apply for an import license at Thai FDA in Thailand.
Food production methods and ingredients are authorized if they meet FDA standards. Food import licenses are renewed every three years.
Tips for Registrations food and Food Supplements:
The completeness of documents is crucial, such as labels, analysis results, 100% formula. Factory Certification GMP, ISO 22000 and follow CODEX protocol
FDA license
To receive food or drug import licenses, you need a lot of information, such as certificates and supporting documents from other authorities which are also helpful for the FDA application. Meanwhile, a well-written or well-documented indication by a Thai FDA specialist could also help speed up FDA approvement. FDA taxes are mostly based on the material applied for.
The required information also depends on the product category. For instance, a food related application usually requires ISO22000 GMP, medical devices need ISO13485, and hazardous substances require a safety data sheet.
These are just a few things to keep in mind for FDA imported registration in Thailand. IDGIP recommends you to engage in our professional FDA services to save time and to have the best chance of a successful FDA application.
Hopefully, this information would be beneficial for your business planning in Thailand.
If there are any questions and suggestions, IDGIP willingly provides advice and helps planning your business.
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