Introduction
The Thai FDA has simplified the registration process for custom-made dental medical devices to reduce the burden on manufacturers who previously faced challenges in providing finished product performance evidence for each individual custom-made device. Under the revised approach, the Thai FDA limits its verification and validation review to raw materials commonly used in global dental practice with an established history of use, instead of requiring comprehensive finished product performance evidence.
List of Applicable Main Materials
Dental Ceramic
- Zirconia
- Lithium disilicate
- Feldspathic (Powder group)
- Indirect Composite Resin (Hybrid ceramic)
Dental Alloy
- Titanium alloy
- Cobalt-Chromium alloy
- Austenitic alloys
- Palladium alloy
- Stainless steel
Dental Polymer
- PMMA
- PEMA
- Hybrid Polymer Resin
- Polycarbonate resin
Requirements for Verification and Validation
Required Raw Material Documents
- Evidence of raw material approval/clearance by foreign regulatory authorities, OR
- Material Safety Data Sheet (MSDS), OR
- Certificate of Analysis (COA)
Manufacturer/Product Owner must declare and certify following
- The device is produced from raw materials with a long history of use, AND
- No novel manufacturing process is applied, AND
- The finished-product manufacturing processes do not impact the material safety and performance.
Important Note
If a custom-made dental device is manufactured from raw materials not listed above, the manufacturer must submit a full finished-product test reports.
As Thailand FDA updates the registration approach for custom-made dental medical devices, the dental device sector may wish to further observe how these documentation expectations could influence future submissions in Thailand. With 26+ years of experience, Qualtech’s Thai team in Bangkok remains available to exchange Thai FDA regulatory perspectives where relevant. Contact us now!