Pushing to bolster the safety and efficacy of medical devices sold in Thailand, the country’s regulatory authority has set out new guidelines on when and under what circumstances a recall is appropriate for devices whose continued presence in the market could affect consumer safety.
Under the guidelines published by the Medical Device Control Division, device manufacturers—or their lawful representatives in the country—are required to report any safety issues or adverse effects to consumers associated with the medical devices they produce.
If a medical device is deemed a safety risk, the manufacturer or responsible party is required to initiate a product recall, to manage the logistics of the recall plan, and to demonstrate to authorities that the recall has been successful.
The guidelines apply to medical devices manufactured, imported, or sold in Thailand.