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
The Government of Indonesia has introduced Government Regulation No. 42 of 2024 on Halal Product Assurance, enhancing and expanding on the prior Government Regulation No. 39 of 2021. This regulation aims to provide legal certainty and assurance to the public regarding the halal status of products available within Indonesia. All
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
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
Regulatory updates, Vietnam On October 4, 2024, the Ministry of Health (MoH) of Vietnam issued three notices—Notice No. 6065/BYT-HTTB to the Department of Health (DoH), Notice No. 6066/BYT-HTTB to medical device manufacturers, and Notice No. 6067/BYT-HTTB to traders, exporters, and importers—calling for a survey of the current situation and gathering
Regulatory updates, Thailand On October 11, 2024, the Thai Food and Drug Administration (FDA) published new guidelines on labeling requirements for medical devices. These guidelines provide clarity on how labels should be attached to medical devices intended for both home use and professional use. The key points of the guidelines
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