Tag Archives: thailand

TFDA Medical Device GDP: Thailand issues new regulation for Good Distribution Practices

TFDA Medical Device GDP

TFDA Medical Device GDP: Good Distribution Practices for Importers of Medical Devices in Thailand – Compliance with New Regulations The regulatory landscape for medical device importers in Thailand has undergone significant changes with the issuance of new TFDA Medical Device GDP regulations under the Royal Gazette, Volume 141, Special Section 4, dated 5 January 2024…. [read more]

Essential Licenses and Quality Certifications for Establishing a Medical Device Factory

Medical Device Factory Thailand

Effective from July 3rd, 2024, to open a medical device factory according to the text provided, the necessary licenses and standard quality certificates are as follows: Licenses and Quality Certifications for Establishing a Medical Device Factory License to Operate: A general license to operate a manufacturing establishment for medical devices. This includes registration of the… [read more]

Company Incorporation in Thailand: an overview of DBD’s Increased Fees

Company Incorporation in Thailand

Company incorporation in Thailand: an overview of DBD’s Increased Fees Thailand’s business landscape is witnessing significant changes in its regulatory framework, particularly in the realm of Company Incorporation in Thailand. The Department of Business Development (DBD) has recently implemented a revision of fees associated with company incorporation, imposing a minimum charge of 6,000 THB per… [read more]

Cosmetic market in Thailand: the guide (Video)

Cosmetic market in Thailand: the guide

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]

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]

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]