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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
Malaysia: MDA Introduces Updated Guidelines for Medical Device Registrations with Expired EC Certificates and Self-Declared Class B IVDs
Medical Device Authority (MDA) only recognized EC Certificate (CE Marking) issued under Directive 90/385/EEC, 93/42/EEC, or 98/79/EC, or,...
ARQon
Sep 4, 20242 min read
Thailand: TFDA Releases Guidance on Diagnostic Test Registration for Monkeypox
On 20 August 2024, the Medical Device Control Division of TFDA released registration guidance for monkeypox (Mpox) diagnostic tests as a...
ARQon
Aug 28, 20241 min read
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