Thai: Specialist Review Guidelines by Thailand Food Drugs and Administration (FDA)

Thailand Food Drugs and Administration (FDA) has released a Specialist Review guideline solving confusion in deciding which device would be subjected to specialist review. FDA requires the Specialist Review as a pre-requirement approval process before entering the market. During the Specialist Review, the Thai FDA will send the technical file to the related expert professional teams from medical or healthcare services to review the devices.

Medical device manufacturers can refer to the guidelines for any criteria that may coincide with their products. Special Review may cause the standard medical device registration timeline extended from 3 months to 6 months and additional fees depending on the devices.

The listed below are the criteria guidelines for medical devices that must undergo detailed review by the professional teams:

Manufacturers may avoid getting reviewed by the Specialist Review if the medical devices have been approved from the origin country or obey the requirement list required by the Thai FDA.

The Specialist Review exemption is given for any medical devices that have been approved 3 years minimum by one of the authorized bodies, or, more than 1 year by multiple authorized bodies, for which the authority body must comply same registration requirement with Thailand.

Otherwise, the medical devices must have been approved by the Thai FDA drug department, or, have been approved and registered under Singapore, or, ensure the medical device has been manufactured in Thailand and sold to governmental medical facilities for 3 years with no bad record, or, lastly making sure there are no changes while importing the medical devices. Hence, medical device manufacturers are advised to check properly on the devices in order to prevent any additional time during the registration process.

Source: Thailand FDA

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