The Food and Drug Administration now allows for the referencing of medical device application dossiers and transfer of product registration licenses.

The deadline for renewing the drug product registration license is approaching. All renewals must be submitted by 12 October 2024

The Food and Drug Administration has recently updated a number of regulations related to certain medical devices to ensure that they are carefully monitored and controlled, have prescribed quality standards, and are safe for consumers. The updated regulations relate to alcohol detecting devices, positive airway pressure devices and dentistry devices.

To promote and support research and development of medical devices in Thailand, the Ministry of Public Health and the Food and Drug Administration have recently issued several notifications providing additional guidance for manufacturers or importers of certain medical devices seeking exemptions from licensing requirements (i.e., the manufacturing or import license, and the product registration license) under the Medical Device Act.

The Thai Food and Drug Administration (FDA) has recently issued two notifications, namely the Notification of the Ministry of Public Health Re: Good Manufacturing Practice, B.E. 2566 (2023), and the Notification of the Ministry of Public Health Re: Good Importing and Sales Practice, B.E. 2566 (2023). These notifications aim to regulate the quality systems of medical device manufacturing facilities, as well as importers and sellers of medical devices.

The Department of Climate Change and Environment under the Ministry of Natural Resources and Environment is pushing ahead with the second draft of the Climate Change Bill (“Bill”), which is currently undergoing the process of public hearing until mid-April 2024. It is expected that the Bill will be considered by the cabinet for approval in principle in June 2024.
The Bill lays out Thailand’s action plan for climate actions and, importantly, imposes obligations and penalties for the private sector for the purposes of advancing climate mitigation and adaptation efforts. Some of the key elements of the Bill are summarized in this article.

Thailand is taking the next step towards strengthening the legal framework on air quality control as the Cabinet approved in principle the Draft Management for Clean Air Act (“Clean Air Bill”), which was proposed by the Ministry of Natural Resources and the Environment (MONRE) on 28 November 2023. Thailand’s current legal framework to manage air quality can be seen in many existing laws that regulate the monitoring and treatment of air pollution, and specify air quality standards. There are many governmental agencies acting as regulators for the purpose of air quality control, including the MONRE, the Ministry of Industry, and the Ministry of Public Health.

With increasing awareness of carbon capture and storage (CCS) technology as a key enabler for decarbonization, many developments in this area, such as exploration for carbon storage sites, have been reported. However, presently, in Thailand, there is no legislation specifically governing such CCS-related activities. In this context, the Department of Mineral Fuels has been developing a legal framework to accommodate CCS-related activities as can be seen from the recent public hearing of the draft amendment to the Petroleum Act, B.E. 2514 (1971) (“Draft Petroleum Act”), which aims to introduce the concept of “carbon business” as another regulated activity in a similar manner to conventional petroleum concessions.

The Carbon Border Adjustment Mechanism (CBAM) is one of the legislative measures under the “Fit for 55” package in the EU’s European Green Deal. The CBAM is a measure designed to complement the EU’s Emissions Trading System, targeting imports of carbon-intensive products, including Thai exporters.

In this final part of the series, we will look at the Draft Waste Electrical and Electronic Equipment Management Act. The development of a legal framework for the management of waste from electrical and electronic equipment (WEEE) has been discussed and studied in Thailand for almost two decades. However, despite existing general environment-related laws, such as the NEQA, the Hazardous Substance Act, B.E. 2535 (1992), and the Factory Act, B.E. 2535 (1992), there is currently no specific Thai law governing WEEE management in a systematic and sustainable way.