Thai FDA simplifies submission requirements for custom-made dental devices

According to regulatory consultancy Qualtech, manufacturers or importers previously had to submit full finished-product test reports for every individual custom-made device. Under the revised approach, this will no longer be required for devices made from materials that are commonly used in dental practice and have an established history of use, provided that certain requirements are met. The defined list of materials includes dental ceramics, such as zirconia, lithium disilicate, feldspathic ceramics in powder form and hybrid ceramics; dental alloys, including titanium alloy, cobalt–chromium alloy, austenitic alloys, palladium alloy and stainless steel; and dental polymers, including PMMA, PEMA, hybrid polymer resin and polycarbonate resin.

For devices manufactured from these materials, manufacturers or importers must submit raw-material documentation as part of the technical evidence supporting the application. This may include evidence of raw-material approval or clearance by a foreign regulatory authority, a material safety data sheet or a certificate of analysis. Manufacturers or importers must also declare and certify that the device is produced from raw materials with a long history of use, that no novel manufacturing process is employed and that the process used to make the final device does not affect the safety or performance of the material. The revised pathway therefore gives greater weight to the materials from which custom-made dental devices are produced and brings submission requirements more closely into line with established dental manufacturing practices.

Part of a wider regulatory debate

The Thai FDA’s approach comes amid wider discussion about how medical device regulation can maintain patient safety and avoid disproportionate documentation requirements for manufacturers. In Europe, manufacturers and industry associations have recently called for changes to Regulation (EU) 2017/745, the EU medical device regulation, arguing that some requirements place a heavy burden on producers of long-established medical and dental devices. The Thai FDA’s revised pathway offers one example of a more targeted approach for custom-made dental devices produced from established materials.