On December 19, 2024, the Indonesian Ministry of Health issued Letter No. FR.03.01/E.V/2728/2024, officially classifying dermal fillers as medical devices. This announcement provides guidance to facilitate the importation of dermal fillers into Indonesia while ensuring compliance with regulatory requirements: Classification of Dermal Fillers Dermal fillers are categorized as medical devices
On December 20, 2024, the Vietnam Ministry of Health (MoH) issued a draft amendment and supplement to several articles of Decree No. 98/2021/ND-CP, dated November 8, 2021, on Medical Devices Management. This draft follows previous amendments introduced by Decree No. 07/2023/ND-CP, dated March 3, 2023. The draft aims to enhance
On December 16, 2024, the Indonesian Ministry of Health issued Notification Letter No. FR.03.01/E.V/2672/2024, classifying Dried Blood Spot as a medical device. This update provides significant regulatory implications for manufacturers, importers, and distributors of the product. Below is a detailed summary of the notification and its key requirements: Details of
On December 9, 2024, the Vietnam Ministry of Health (MoH) issued Official Dispatch No. 7614/BYT-HTTB, addressing the supply of medical devices whose import licenses will expire on December 31, 2024. This notice outlines measures to ensure an uninterrupted supply of medical devices while emphasizing compliance with regulatory requirements. Key Actions
On November 21, 2024, the Vietnam Ministry of Health (MoH) issued Decision No. 3514/QD-BYT, officially abolishing Decision No. 5086/QD-BYT and Decision No. 2807/QD-BYT. These decisions previously governed the list of manufacturer’s codes and the encoding of medical supplies for health insurance and healthcare expenses. Updated Guidelines for Medical Supplies Codes
In October 2024, the Ministry of Health (MoH) of Vietnam issued Circular 19/2024/TT-BYT, which promulgates the list of medical devices assigned Harmonized System (HS) codes. This update follows Circular 31/2022/BTC on Vietnam’s nomenclature of exports and imports. The new circular takes effect from November 16, 2024, and replaces the previous
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