On August 5th 2024, the Vietnam Ministry of Health (MoH) issued Decision No. 2302/QD-BYT regarding the promulgation of Guidelines for the Evaluation of Legal Documents for Registration Dossiers of Medical Device Class C and D. This decision replaces Decision No. 3007/QĐ-BYT dated November 3, 2022. There are no changes to
From a conference attended by Andaman Vietnam team on July 11, 2024, the Ministry of Health announced that they are preparing to submit to the Government a draft Law on Medical Devices by December 2024. Currently, medical devices in Vietnam are under the management of some valid regulations such as:
Last July 24, 2024, Thailand FDA released an infographic about Advertisement of Medical Devices Direct to Health Professionals. The summary of the information is as follows: Advertising medical devices that are exempt from authorization to healthcare professionals is a form of direct advertising with specific characteristics and methods aimed only
Indonesia’s government has officially issued Government Regulation No. 28 of 2024 concerning Implementing Regulation for Law No. 17 of 2023 concerning Health has been officially signed by Indonesia President, Joko Widodo on 26 July 2024. In order to increase health capacity and resilience within the framework of Health transformation to
On July 26, 2024, the Indonesia Ministry of Health (MoH) issued a letter numbered FR.01.01/E.V/1652/2024 regarding the Appeal for Filling in Pharmacy and Medical Device Dictionary Data (KFA). The Satu Sehat Logistik Platform (National Digital Inventory) is a platform for stock monitoring national drugs and Medical Consumable (BMHP: Barang Medis
On July 16, 2024, the Indonesia Ministry of Health (MoH) issued an announcement letter No. FR.01.01/E.V/1537/2024 regarding the Appeal for Filling in Medical Device Dictionary Data. The MoH has again requisitioned all companies holding active product licenses for medical devices to fill in the Pharmacy and Medical Devices Dictionary (KFA)
Subscribe to our Newsletter
Be the first to receive essential updates on regulatory changes, market trends, and industry insights from us!
