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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
France: ANSM Designates AFNOR as the Newest Notified Body
Medical devices to be marketed in the European market must obtain CE Marking as proof the devices meet the highest safety, health, and...
ARQon
Jun 12, 20241 min read
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