medical device registration

Sep 4, 20242 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,...

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Aug 28, 20241 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...

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