Category Archives: Regulatory and Compliance

FOOD CLASSIFICATION IN THAILAND

Food Classification in Thailand

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 RISK CLASSIFICATION THAI FDA

MEDICAL DEVICES RISK CLASSIFICATION in Thailand

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]

THAI FDA Medical Device Classification – Risk based

Thai FDA Medical Device Classification

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]

Biobarica Portable Hyperbaric Chambers

Biobarica Portable Hyperbaric Chambers

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]

FDA allows Thai cosmetics manufacturers to use shared premises

Thai Cosmetics manufacturers

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]

Products missing Thai FDA license sized by police

Thai FDA license

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]

We’re Hiring a Content Editor / E-shop Manager

CONTENT EDITOR / E-SHOP EDITOR

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]

Thailand Cosmetic Regulatory Webinar

Thailand Cosmetic Regulatory Webinar

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.

Covid Test Registration in Thai FDA

Covid Test Registration in Thai FDA

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]

Market Access to Thailand: All You Have to Know on Dietary Supplements Regulation

Market Access to Thailand: All You Have to Know on Dietary Supplements Regulation

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]

ISO 9001 certification for food supplements registration

food supplements registration in Thailand

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.

Fully Foreign Owned Company in Thailand

Fully Foreign Owned Company in Thailand

Fully Foreign Owned Company in Thailand: possible and convenient Despite what is believed, opening a Fully Foreign Owned Company in Thailand (company with 100% foreign shares) is possible by taking advantage of certain government structures and incentives. Let’s see in which cases it is not only possible but convenient. BOI promotion A limited liability company… [read more]

Online Alcohol Sales ban in Thailand

Online Alcohol Sales ban in Thailand

The new Announcement of the Office of the Prime Minister will enforce the Online Alcohol Sales ban in Thailand from December 8th, 2020. The amendment of two sections of the Alcoholic Beverage Control Act signed by Thai Prime Minister on September 8th defines that no one could sell or provide service to consumers related to… [read more]

New Procedure for Registration of Medical Device in Thai FDA

Registration of Medical Device

Bangkok, 06/11/2020 A new Procedure for Registration of Medical Device in Thai FDA will be enforced soon, probably from early December. This is what came out from our latest visit to Medical Device Division in Thai FDA of Nonthaburi, the main office controlling all the Kingdom of Thailand. The new procedure is not effective yet:… [read more]