In-Vitro Diagnostics

By: Carsl Consulting  06-Dec-2011
Keywords: Medical Devices, Therapeutic Products

Under the proposed Australia New Zealand Therapeutic Products Authority (ANZTPA) in-vitro diagnostics would be controlled in a similar fashion to medical devices.  However, there is now uncertainty regarding the future of ANZTPA but it is expected that in-vitro diagnostics will eventually come under some regulatory controls in the future.  We can provide advice on the regulatory controls as they become apparent to ensure compliance for your in-vitro diagnostics.

Keywords: Medical Devices, Therapeutic Products

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Other products and services from Carsl Consulting

06-Dec-2011

Regulatory services for Prescription and Non Prescription Medicines

Medicines with approval that undergo material changes may also require Medsafe approval through a Changed Medicine Notification before these changes can take effect. Both Prescription and Non-prescription medicines require approval by Medsafe before they can be distributed in New Zealand. Advice and co-ordination for product development or product sourcing. Changed Medicine Notification preparation, submission and follow-up.


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Complementary Medicines

We take every opportunity to provide input into proposed regulations and guidelines for complementary medicines and products at the food/medicine interface and can provide advice concerning forthcoming regulatory requirements. While we support the regulation of complementary medicines in New Zealand, we recognise that such regulation should take into account the nature of the product and of inherent risks involved in their use.


06-Dec-2011

Medical Devices

We take every opportunity to provide input into proposed regulations and guidelines for medical devices and can provide advice on the regulatory controls as they become apparent. The regulatory controls on medical devices were expected to increase significantly on commencement of the Australia New Zealand Therapeutic Products Authority.


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Pfizer Chemicals

We also supply full technical support for ingredients supplied in New Zealand and can handle any regulatory aspects involved with their use. CARSL Consulting is the New Zealand agent for the Pfizer Centre Source range of pharmaceutical active ingredients. These include corticosteroids, hormones and antimicrobials.