Amendment to the Control Procedures for the Manufacture and Importation of Medical Devices in Thailand

1. Introduction
In Thailand, medical devices are regulated by the Medical Device Control Division of the Food and Drug Administration (“FDA”), which is under the Ministry of Public Health (“MPH”). Pursuant to the Medical Device Act of 2008 as amended (“MDA”), the term “medical devices” is broadly defined to include not only hardware but also software intended to be used for medical purposes , for example, according to the FDA’s publication, one of the reputable smart watch brands with electrocardiogram (ECG) feature was approved by the FDA as a medical device. Generally, the manufacture, importation or sale of medical devices in Thailand is prohibited unless clearance is obtained through the control procedures required by the FDA under the MDA.

On 21 November 2014, Thailand entered into the ASEAN Agreement on Medical Device Directive and since that date, Thailand has been committed to undertaking all necessary measures regarding medical devices to comply with the provisions stated therein. As a result, in 2019, legislation to amend the MDA was passed. Additionally, the MPH issued a law classifying medical devices based on their risk levels so as to clarify the previous medical device classifications created in 2015. Thereafter, in order to comply with such classifications and to even more efficiently regulate businesses in relation to medical devices, the FDA also significantly revised the control procedures for the manufacture and importation of certain medical devices by enacting a number of regulations earlier this year. The new regulations were recently published in the Royal Thai Government Gazette on 15 February 2021 and currently remain in effect.

This article aims to provide a general summary in respect of the medical device industry in Thailand under those newly issued regulations and the relevant regulations for the benefit of manufacturers and importers of medical devices.

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