Tag Archives: regulatory

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]