Take the difficulty out of on going compliance using a KD&A Post Market Surveillance System
It is a requirement that all medical devices and IVDs included on the ARTG be monitored whilst on the Australian market. Post-market monitoring is a combination of proactive and reactive actions, and is a mandatory regulatory requirement.
KD&A’s Post-Market Surveillance Systems are designed to guide your organisation in the process of completing post-market actions such as product development, and product recall. This includes a Feedback Procedure based on the Australian Therapeutic Goods (Medical Device) Regulations 2002 as amended, and includes associated event reporting forms.
Indicative Fee: AUD$1,237.50 plus GST
Contact us if you require a custom quote.
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