Thailand Establishes Fast Track To Approval Of Class 4 Medical Devices

Manufacturers seeking licenses to sell high-risk medical devices in Thailand will have a route to do so more rapidly and at less cost under a new agreement struck between regulatory authorities in the country and their counterparts in Singapore.

Under the agreement, the Food and Drug Administration of Thailand will allow fast-track registration of Class 4 devices already approved by regulators in Singapore. That will save manufacturers the cost of and time of conducting a separate expert review process in Thailand.  To be eligible, applicants will have to submit evidence that the device has been registered in Singapore, among other proof and documentation.