THAI FDA REGISTRATION
Thai FDA Registration is mandatory for a list of product imported or manufactured in Thailand. In detail, the import of drugs (pharmaceuticals), food supplements, food, medical devices, cosmetics, products for animal health and every medical and/or hazardous substance is subject to Food and Drug Administration – Thai FDA registration.
The approval from Thai FDA must be obtained before importing any of the above enlisted products. Each category has separate registration requirements and procedures.
THAI FDA DRUG REGISTRATION
Importers of drugs must obtain Thai FDA approval prior to importing their medicines in Thailand. Thai FDA categorizes drugs into 4 categories: modern medicines, general medicines, traditional medicines, and veterinary medicines. Each one of them has separate registration requirements. The category named “general medicines” is grouped into 3 separate categories: generic medicines, new medicines, and new generics. Each medicine category has a distinct set of registration requirements.
THAI FDA MEDICAL DEVICES REGISTRATION
Thai FDA has a special department managing Medical Device Registration. Such products require either licensing or registration, according to the CLASS where they are enlisted.
ASEAN Medical Device Directive (AMDD) is in force since February 15, 2021 . We always perform a pre-check with Thai FDA Officers to define the right definition and class of each product.
The new regulation is a risk-based classification system based on ASEAN MDD guidance. Formerly most medical devices fell under the General Medical Device category and were subject to a simple listing process. Only a handful of medical devices were subject to the more rigorous Notification and Licensing reviews. Now all Class 2, 3, and 4 device applications will require full technical data in Common Submission Dossier Template (CSDT) format with a grace period for some documents. Medical device Import License applications will need to be submitted via one of three routes (from low risk to high): Listings, Notifications, and Licenses. Certificates of Free Sale (CFS) will no longer be required as part of the registration process.
|Previous classification||New classification||Date comes into force|
|General||Class 1 – Listing||Class 1: March 17, 2021|
|Notified||Class 2 – Notified
Class 3 – Notified
|Classes 2, 3 and 4: February 15, 2021|
|Licensed||Class 4 – Licensed|
THAI FDA REGISTRATION FOR COSMETICS
In the past, the Thai FDA was used to classify cosmetics into two categories based on the composition of the cosmetics:
Controlled cosmetics: Cosmetic products made by a certain list of ingredients required product notification to the FDA before products were allowed to be released on the market.
Specially controlled cosmetics: Cosmetics made with specially controlled ingredients required registration.
Actually, regulation changed in order to harmonize it with the incoming ASEAN legislation. Thus, Thai FDA registration for cosmetics follows only one procedure: Cosmetics must be registered and the list of ingredients, together with all relevant information, must be kept in the Product Identification File, under the responsibility of License Holder.
THAI FDA FOOD SUPPLEMENT REGISTRATION
All the products intended for human consumption must be registered in Thai FDA. Food supplements and dietary supplements have a special Department managing their permission. According to Thai FDA Registration procedure, food and dietary supplements must be labeled in Thai language and their promotion must follow specific rules. Every dietary/food supplement wrongly managed by the importer is at risk to be considered by Thai FDA as drug. This will change the time for licensing from few weeks to several months.
HOW CAN I GET A THAI FDA LICENSE FOR MY PRODUCTS?
There’s no way for the foreign manufacturer to get a license under his company name: only Thai entities (subject to several license and controls) can register a product in Thai FDA.
Also warehouse must be licensed, specifically for your kind of products. The suggestion is to use companies with specific expertise and with a consolidated structure in this sector.
Kha Bangkok has its own internal regulatory and can perform Thai FDA registration, license holding and distribution (sales and post sales) for you.The logistic partnership allow you to have only one referent for the entire chain in Thailand.