Good Distribution Practice for Medical Devices in Thailand

2018-10-24T14:37:02+08:00 August 3rd, 2018|News & Events|
Good Distribution Practices

The Good Distribution Practices regulation in Thailand will apply to manufacturers, importers, and distributors and will require them to gain Good Distribution Practices certification to ensure quality, safety, and performance throughout the supply chain.

The Thailand Public Health Ministry has published a notification in the Royal Gazette regarding the Good Distribution Practices (GDP) regulations for Medical Devices B.E 2561.

The GDP regulations will apply to manufacturers, importers, and distributors and will require them to gain GDP certification to ensure quality, safety and performance throughout the supply chain.

Medical devices in the following categories are to be regulated as a priority:

1. Temperature-controlled medical devices (≤ 15 degree Celsius)
2. High-risk medical devices
3. Electrical medical devices
4. Medical devices to be installed
5. Sterilized medical devices