Thailand to allow some medical devices already approved in certain developed countries faster approval

Some medical devices already registered for sale in two of the five countries including Australia, Canada, the European Union, Japan or the United States for over one year that have not had serious adverse events will be eligible for quicker approval in Thailand under a new guidance that went into effect in November. The amendment to the Medical Device Act means that manufacturers will be able to bring devices to market faster and, by cutting the time and effort previously needed to have products evaluated by Thai authorities, incur fewer costs. In order to qualify, applicants must be able to provide documentation of market approval, proof that no safety issues have been associated with the use of the device, and a letter declaring that the device does not differ in quality and other aspects from the device approved in these other countries.