Regulatory Updates

Indonesia: Deactivation of the Electronic Catalogue System Version 5

On October 30, 2024, the Deputy for Digital Procurement Transformation at Indonesia’s National Public Procurement Agency (LKPP) issued a decision to deactivate the Electronic Catalogue Version 5, aimed at streamlining the e-Catalogue business process. Key Conditions for Deactivation: Key Conditions for Deactivation: Deactivation of Product Showcase Creation for Local/Sectoral e-Catalogue:

Thailand: Draft Announcement on Medical Device Advertising Licenses by the Thai FDA

The Thai Food and Drug Administration (FDA) has issued a draft announcement detailing the criteria, methods, and conditions for requesting, issuing, and managing licenses for medical device advertising. This new draft aims to regulate and control medical device advertisements to ensure accurate, ethical, and culturally appropriate messaging. Key Highlights of

Indonesia: Important Requirement for IDAK (Medical Device Distributor License) Holder

On October 30, 2024, the Director of Medical Device Production and Distribution in Indonesia issued Notification Letter No. FR.03.06/E.V/1905/2024, outlining new requirements for fulfilling the Medical Device Distributor License (IDAK). This letter introduces key conditions that distributors must meet to maintain compliance under the new regulations. You can access the

Thailand: Guidelines for Determining Health-Type Software Products

The Thai Food and Drug Administration (FDA) has reissued Guidelines for Determining Health-Type Software Products to help medical device registrants obtain accurate classification information. These guidelines provide clarity on which software products qualify as medical devices under Thai law, aiding stakeholders such as manufacturers, importers, and public health agencies in

Regulatory Affairs Update: Indonesia

Indonesia: Announcement on International Tender Procurement by Ministry of Health

On October 10, 2024, Indonesia’s Ministry of Health (MoH) announced the opening of an International Tender Procurement for a project named Strengthening Indonesia’s Healthcare Referral Network (SIHREN). The official announcement is available on the e-Catalogue website in both Indonesian and English. You can access it here. Further details about the

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