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Indonesia: New KFA Registration Guide for Medical Device License Holders
The Indonesian Ministry of Health has announced crucial updates regarding the registration of medical devices in the Kamus Farmasi dan...
ARQon
Mar 112 min read
Indonesia: Dried Blood Spot (DBS) Products Now Classified as Medical Devices (w.e.f. 9 December 2024)
Recently, the Ministry of Health of Indonesia announced that Kertas Saring, also known as Dried Blood Spot (DBS) , will be recognized as...
ARQon
Dec 30, 20242 min read
Indonesia: Online Certification and Medical Device Licensing Systems to Close Temporarily
The Ministry of Health of Indonesia has temporarily closed the Medical Device Licensing and Online Certification Systems for scheduled...
ARQon
Dec 23, 20242 min read
Indonesia: New Requirements for Medical Device Distributors Licensing Compliance (w.e.f 1 January 2025)
The Ministry of Health of Indonesia has introduced new guidelines for medical device distributors to enhance regulatory compliance,...
ARQon
Nov 12, 20241 min read
Indonesia: Mandatory GDP Certification for Medical Devices in the e-Katalog (w.e.f 1 January 2025)
The Ministry of Health of the Republic of Indonesia released a circular no. HK.02.02/E/1753/2024 to address the implementation of the...
ARQon
Sep 23, 20241 min read
Indonesia: Implementation of GDPMD Certification (CDAKB) as Marketing Authorization Requirement
The Indonesia Ministry of Health published an announcement on 11 May 2024, under Announcement No: FR.03.01/E/884/2024 about the...
ARQon
May 29, 20241 min read
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