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Praween Chantanakomes

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Praween Chantanakomes is the Head of Regulatory Affairs Department in Baker McKenzie, Bangkok office.

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 Entertainment Complex Policy Parliamentary Committee has considered and endorsed the draft Entertainment Complex Bill, B.E. (“Entertainment Complex Bill”), a concept initiated many years ago. The Entertainment Complex Bill aims to facilitate the establishment of entertainment complexes that include casinos. This has been passed to the House of Representatives in March 2024.

The Food and Drug Administration (FDA) has issued the Notification of the Ministry of Public Health Re: Prescribe Types of Cosmetics, Criteria, Methods and Conditions for Refill Stations, B.E. 2566 (2023) and the Cosmetic Committee Announcement Re: Labeling of Cosmetic at Refill Stations, B.E. 2566 (2023). Both notifications were published in the Government Gazette on 23 August 2023 and will become effective on 21 November 2023. These notifications are intended to be in line with the global Bio-Circular-Green Economy trend, which seeks to reduce plastic waste and promote the recycling of plastic.

In the second episode of our Digital Transformation in the Healthcare Industry series, the Healthcare and Life Sciences team at Baker McKenzie brings us up to date with the current laws and regulations relating to telemedicine and telepharmacy in Thailand and associated issues.

The “provision or acceptance of gift policy” is a key compliance principle in the governmental sector, as reflected in several key pieces of legislation. On 13 January 2023, the Office of the Prime Minister issued the Regulation on the Provision or Acceptance of Gift of Governmental Officials, B.E. 2565 (2022), which came into effect on 14 January 2023. This regulation updates and strengthens the policy on the provision or acceptance of gifts for the governmental sector. The regulation applies to all government officials, including but not limited to officials, staff, and employees of government agencies and state-owned enterprises.

Governance plays a key role in protecting a company from undesirable misconduct and may help to mitigate some of the consequences of non-compliance, whether in terms of civil or criminal liabilities of the company itself or its board of directors.This article explores ESG from the corporate governance and management perspective.

Under the current regulation, a Good Manufacturing Practice (GMP) certificate obtained from the Food and Drug Administration (FDA) is a voluntary requirement for local medical device manufacturers. However, manufacturers of licensed medical devices and detailed notification medical devices must provide GMP certificates from the FDA or an ISO 13485 certificate issued by one of the official Certified Bodies as part of the documents for the registration of medical devices. These certificates are not required to manufacture and notify low-risk medical devices unless they are exported and certain certificates are required by the destination countries.