New Rigor in Technical Documentation of Medical Devices Required by Thai FDA

Moving to better ensure the safety and efficacy of medical devices offered for sale in Thailand, the country’s Food and Drug Administration (FDA) in October issued a list of technical specifications for devices that must be presented to authorities on request.

Under the Thai FDA directive, manufacturers of medical devices must be prepared to provide technical documentation affirming the safety, performance, components, labeling, purpose, shelf life, contraindications, and risks of most Class A through D devices licensed for sale or use in Thailand. Until now, licenses could be obtained in the country for most medical devices without submitting too many technical documents.

While the documentation need only be submitted on request from Thai authorities, holders of local licenses for the products are required to maintain the documentation in full for between one and five years after the product’s listed expiration date.