Thai FDA Medical Device process has changed. Thai FDA’s recent decision to terminate the medical device CSDT dossier in “partial 2” submission has sent ripples through the healthcare industry. With only the “full submission” option remaining effective from February 14, 2024, medical device manufacturers and stakeholders are facing a paradigm shift in regulatory compliance and… [read more]
Category Archives: Medical Device
Medical Device, Regulatory and Compliance
Streamlining Medical Device Registration in Thai FDA: A Comprehensive Guide
27
Dec
Dec
Introducing Medical Device Registration in Thai FDA Navigating the regulatory landscape for medical device registration in Thailand is crucial for manufacturers and distributors aiming to bring their products to market. The Thai Food and Drug Administration (FDA) plays a pivotal role in ensuring the safety and efficacy of medical devices. This comprehensive guide outlines the… [read more]
Cosmetics, Medical Device, Regulatory and Compliance
Registering injectable products as cosmetics: is it legal?
25
Sep
Sep
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]
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]
Medical Device, technical information
Electromotive Drug Administration EMDA – Mitomycin in bladder cancer treatment: a prospective observational study
12
Sep
Sep
A prospective observational study on Electromotive Drug Administration (EMDA®- Mitomycin) in bladder cancer treatment is under process in a major Institute in Thailand in order to prove efficacy of EMDA, medical device produced by Physion Srl in Italy and distributed by Siam Trade Development in Thailand. The study is the prelude to a project of… [read more]