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Praween Chantanakomes

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Praween Chantanakomes is a Legal Professional in Baker McKenzie, Bangkok office.

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.