In-Vitro Diagnostics (IVD’s)
IVDs are categorised as Medical Devices under the Medicines Act 1981. We can provide advice on the regulatory controls as they become apparent to ensure compliance for your in-vitro diagnostics.
In-vitro diagnostics (IVDs) require specialized regulatory support due to their critical role in patient care. CARSL Consulting provides:
- Regulatory Advice: Stay ahead of evolving requirements for diagnostics under ANZTPA.
- Performance and Compliance Monitoring: Ensure IVDs meet safety and accuracy standards.
- International Market Entry Support: Navigate registrations for Australia, Europe, and beyond.”
Whether launching new diagnostics or maintaining existing products, trust us to ensure compliance.