Registering injectable products as cosmetics: is it legal? On September 22, 2023, FDA published an article on the official page https://oryor.com regarding a raid carried out together with the central investigative police and the public health office. The purpose of the control was to verify the use of cosmetics packaged in vials/ampoule containers used improperly… [read more]
Category Archives: Regulatory and Compliance
24
Aug
Aug
Veterinary Medical Devices for Animals is a new niche going to develop quickly, considering that Thai culture is getting always more inclusive with pets. Animals are becoming part of families, so they need prevention and treatments like humans. WHAT IS THE DEFINITION OF MEDICAL DEVICE? Under Thai law, the definition of a medical device is… [read more]
17
Jun
Jun
Nominee shareholder in Thai Company are forbidden by law. This is the fact. Is the sadly common “don’t worry my friend, I have big connections” approach used by some “fish market attorney” still working? Let’s see in detail. What is a nominee shareholder? In a nominee shareholding structure the Thai shareholder are deemed to hold… [read more]
05
Apr
Apr
HOW TO GET TISI LICENSE TO IMPORT INDUSTRIAL PRODUCTS IN THAILAND TISI license to import industrial products in Thailand is a 4 steps process. 1 Submit the application to access the service through TISI e-license system (e-submission) for product testing and Quality Control system assessment. Request the authorization to import samples for testing… [read more]
20
Jan
Jan
Is my ingredient considered as novel food in Thai FDA? How can I evaluate it? FIRST STEP: MAY MY INGREDIENT BE A NOVEL FOOD IN THAI FDA? The first step to identify a novel food in Thai FDA is to verify if this ingredient is included or not in the food ingredient database. Such… [read more]
14
Jan
Jan
New rules for limited company in Thailand New rules for limited company in Thailand: from March 2023, the Ministry of Commerce will reduce the minimum required shareholders for a Limited Company in Thailand from 3 to 2 shareholders. If confirmed, this will ease the formation of Thai Limited Company and its management. Background On 14… [read more]
06
Nov
Nov
We just installed a Food Repacking Factory in Thailand, ready to go. Siam Trade Development increased the services for its clients, by installing a fully licensed Repacking Factory in the venue in Pathum Thani. The factory shall be operating from January 2023 and will be allowed to repack a list of food products on behalf… [read more]
30
Jul
Jul
Our webinar on Cosmetic Market in Thailand, broadcasted on July 27th in the Chemlinked Platform, was a huge success. 257 subscibers, 75 attendants for the full event, and a positive rating of 96% shows that the argument is interesting and was analyzed with the righ approach. In the event, our Managing Director Diego Sala gave… [read more]
12
Jul
Jul
On July 6th, at 15:00 Bangkok time, our CEO, Dr. Diego Sala had a speech in a Webinar on Novel Food Registration in Thailand, hosted by the platform Chemlinked, located in Guanzhou, China. More than 80 attendants followed the event and after that asked lot of questions, showing that Novel Food Regulation in Thailand is… [read more]
19
Jun
Jun
Foods law in Thailand defines how food is considered, classified, and its related safety prescription. The law in subject is the Food Act, issued on May 8th, 2522. According to the Food Act, “Food means edible items and those which sustain life”. Food includes the following: (1) Substance can be eat, drunk, sucked or gotten… [read more]
11
Jun
Jun
What is my Food Classification in Thailand? Which kind of license my food needs? According to the Notification of the Ministry of Public Health (No. 389) B.E 2561 (2018), Re: Food Additives (No.5), the Food Classification in Thailand follows the scheme that we report in this article. Should you want to download a PDF printable… [read more]
Medical Devices, Regulatory and Compliance, technical information
MEDICAL DEVICES RISK CLASSIFICATION THAI FDA
15
May
May
MEDICAL DEVICES RISK CLASSIFICATION IN THAI FDA What is the classification of my medical device in Thailand? here’s the answer Medical Devices risk classification are clearly stated in the official documentation issued in 2021, following the new regulations issued in 2021. Since then, we receive from new customers always the same question: what is… [read more]
14
May
May
Thai FDA Medical Device Classification – Which class is my Medical Device in Thailand? The New Announcement on Medical Device Regulation issued in 2021 transited the THAI FDA Medical Device Classification from Policy-based to Risk-based. Thai FDA categorizes Medical devices into 3 categories which are Licensed Medical Device, Notified Medical Device, and Listing. Doing… [read more]
14
May
May
Biobarica Portable Hyperbaric Chambers received the final approval by Thai FDA and shall be distribuited in Thailand by Time Warp Engineering Co., Ltd. Revitalair® 430 by Biobarica Portable Hyperbaric Chambers, manufactured in Argentina by Oxavita Srl., concluded its regulatory process managed by Siam Trade Development, and has been approved for import as Class 2 Medical… [read more]
26
Mar
Mar
To the delight of Thai cosmetics manufacturers, FDA allows the use of cosmetic production facilities in conjunction with other health products. This FDA decision will help operators reduce costs and face economic competition. The Deputy Secretary-General of the Food and Drug Administration revealed that at present, many entrepreneurs wish to use the production site of other types… [read more]
19
Mar
Mar
Medical device bundles can be grouped in 6 different ways: SINGLE, SYSTEM, FAMILY, SET, IVD, TEST KIT and IVD CLUSTER, which can be submitted using the same request, in only one license
17
Feb
Feb
Police and Thai FDA raided on Feb 15th a warehouse finding 30 million THB value of products missing Thai FDA license and evidently fake or counterfeit. Royal Thai Police and Thai FDA jointly announced the results of operations in the case of a warehouse raid where they found a large number of counterfeit products of… [read more]
Business Opportunity, Regulatory and Compliance, Siam Trade Development
We’re Hiring a Content Editor / E-shop Manager
04
Dec
Dec
Siam Trade Development Co., Ltd. is looking for a CONTENT EDITOR / E-SHOP EDITOR; the company offers services in Regulatory, compliance and B2C channel management in Healthcare sector. We are working with leading brands from several Countries; we work in an international environment and we are a customer-oriented company with strong ethic values. We are… [read more]
21
Nov
Nov
Siam Trade Development will represent Thailand Cosmetic Regulatory in a Webinar/training program organized jointly by Cosmetic, Toiletry and Fragrance Association of Singapore (CTFAS) and Cosmetics Advancement Committee of China Healthcare Association (CACHCA), with support of other Chinese associations or government organizations.
13
Oct
Oct
Covid Test Registration in Thai FDA is mandatory to import any kind of Covid Test Kit (PCR/Antigen Test Kit, OTC test/self-test/professional test) in Thailand. The Procedure for Covid Test Registration in Thai FDA is divided in two macro-areas: Self Test – Over the Counter Covid test for professional use The updated list of already approved… [read more]
23
Aug
Aug
Eagle Tech Dietary Supplements, a line of products for sport nutritions, arrived in Thailand and are ready for the major e-commerce platforms
Business Expansion, Regulatory and Compliance, technical information
Market Access to Thailand: All You Have to Know on Dietary Supplements Regulation
11
Aug
Aug
Dietary Supplements Regulation in Thailand: here we go again! After the success of the last webinar on Cosmetic Regulatory, Our Managing Director, Dr. Diego Sala, will be sole speaker of a new webinar organized by our partner Chemlinked in Hangzhou, China. In one hour speech, Diego will give data on how to access Thai Market… [read more]
Regulatory and Compliance, technical information
ISO 9001 certification for food supplements registration
27
Apr
Apr
On February 9, a resolution was passed that prohibits the use of ISO 9001 certification in order to obtain permission to register food supplements in Thailand. With effect from April 9, the new regulation came into force, putting all foreign producers without ISO 22000 certification out of the question.
14
Apr
Apr
The inactive company in Thailand is a legend born thanks to the internet and can represent a problem for small investors, especially foreigners.
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