Medical Device Regulatory Seminar Proposed Requirements for In-vitro Diagnostic Devices Thursday 2 December, 2004 Trevor Nisbet Medsafe In-Vitro Diagnostic Devices Medsafe: Marilyn Anderson Derek Fitzgerald Trevor Nisbet Barbara Cavanagh Becci Slyfield TGA: Shelley Tang Robyn Wood Structure of Medsafe • Medicines Act 1981/Misuse of Drugs Act 1975 MANAGER Business Development & Support Team Compliance Team Evaluation Team Medicine Control Team Trans-tasman Agency • The Joint Scheme will – Introduce legislation based on international best practice – Improve protection of public health and safety – Faciliate trade and closer economic relations between Australia and New Zealand Progress to Date 1. New interim legislation: • Medicines (Database of Medical Devices) Regulations 2003 • Established a notification database of medical devices in New Zealand known as WAND (Web Assisted Notification of Devices) • In-Vitro Diagnostic devices currently exempted from WAND Purpose of WAND • To identify NZ sponsors and manufacturers of devices imported or manufactured in New Zealand • System is a notification scheme not an approval scheme • Information being collected is based on the recommendations of the Global Harmonisation Task Force • Information collected will allow the devices to be continued to be supplied to New Zealand for a transition period after the Joint Agency is formed. • After the transition period devices will be required to comply with the Joint Agency requirements. WAND Database Information being recorded: • Name and address of NZ sponsor • Name and address of manufacturer • Device classification – Class 1, IIa, IIb etc • Global Medical Device Nomenclature Code (GMDN code) • Purpose of the device • Manufacturing evidence (optional) Information recorded on WAND on 22 October 2004 Number of sponsors registered: 250 Number of sponsors submitted: 151 Device Notifications: 6365 – AIMD - 166 – Class III - 477 – Class IIb - 765 Device Incident Reporting Form • See Medsafe website – www.medsafe.govt.nz Device Incident Reporting Form • See Medsafe website – www.medsafe.govt.nz Device Recalls / Complaints Investigated Device Diagnostic recalls/upgrades recalls/upgrades 1 July 2003 to 30 471 190 64 June 2004 1 July 2004 to 26 161 64 15 November 2004 Current New Zealand system controlling IVDs • Medicines Act 1981 defines a pregnancy test as a medicine. • Any diagnostic test administered to a person is controlled under the Act as a medicine eg barium meal. • All other in-vitro diagnostic tests are classified as devices. • Concerns especially wth home use IVD devices for serious diseases – eg HIV kits. • Section 58(1) d of the Medicines Act 1981 states that no person shall publish an advertisement inviting correspondence on the sending of hair, blood, urine or bodily specimens or photographs for the purpose of diagnosis or treatment of a condition. Proposed Joint Agency – July 2005 • Current legislation to be replaced by rules • Proposed scheme has been developed by TGA and Medsafe to control IVD’s • This seminar is to give information on proposed scheme to control IVD’s before drafting rules become available • Industry will be able to comment on the drafting rules Definition of In Vitro Diagnostic Device IVDs can be described as test kits and instruments used to carry out testing on human samples, where the results are intended to assist in clinical diagnosis or in making decisions concerning clinical management.
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