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Thailand agrees to accept CE-marked devices

The Thai medical device regulatory agency, the FDA, has agreed to accept CE-marked devices produced in 17 of the European Economic Area (EEA) countries - Iceland is not included in the list. Companies will no longer need to produce a certificate of free sale from the country of origin to market these devices in Thailand.

The Thai medical device regulatory agency, the FDA, has agreed to accept CE-marked devices produced in 17 of the European Economic Area (EEA) countries - Iceland is not included in the list. Companies will no longer need to produce a certificate of free sale from the country of origin to market these devices in Thailand.

Guidelines issued by the Thai FDA state that companies will be required to submit an "EC certificate" issued by the...

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