Medical Device Reporting In New Zealand

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Medical Devices Home Page - Medsafe

https://medsafe.govt.nz/devices/devices-landing.asp

Information for Medical Device Suppliers. Medicines and Medical Devices Recall Code. Device Information. New Zealand Definitions. Medical Device Legislation. Overseas Medical Device Regulators. If you have a query that is not answered by the information …

Adverse Event Reporting - Medsafe

https://www.medsafe.govt.nz/regulatory/DevicesNew/9AdverseEvent.asp

Regulatory Guidance for Medical Devices - Medsafe

https://www.medsafe.govt.nz/regulatory/devicesnew/industry.asp

Advertising of Medical Devices; Conducting Clinical Trials in New Zealand; Surgical Mesh. Adverse Event Reporting; Medsafe Actions; Information for Healthcare Professionals; …

Frequently Asked Questions - Medsafe

https://medsafe.govt.nz/regulatory/DevicesNew/faqs.asp

If not exempted, all medical devices supplied in New Zealand must be notified. If you think your product is exempt please refer to Schedule 1 to the Medicines (Database of …

Medical device registration and approval in New Zealand - Emergo

https://www.emergobyul.com/services/medsafe-medical-device-registration-new-zealand

New Zealand market notification process for medical devices. Although pre-market approval of medical devices is not necessary in New Zealand, market entry does require listing …

Regulatory Requirements for Sponsors - Medsafe

https://www.medsafe.govt.nz/regulatory/devicesnew/3-6RegulatoryRequirements.asp

This Regulation requires a sponsor to notify a medical device to the database within 30 working days of becoming the sponsor. The interpretation of the 30 working day …

Current Regulatory Guidelines - Medsafe

https://www.medsafe.govt.nz/regulatory/current-guidelines.asp

New medicine application (PDF 2 MB, 66 Pages) New and changed related products (PDF 333 KB, 12 pages) Appendix 8: Data requirements for new medicine applications (PDF …

Conducting Medical Device Clinical Trials in New …

https://www.medsafe.govt.nz/regulatory/DevicesNew/13ConductingClinicalTrials.asp

Medical Devices Conducting Medical Device Clinical Trials in New Zealand Medsafe does not regulate or approve clinical trials for medical devices in New Zealand, but does …

Medical Device Registration in New …

https://omcmedical.com/medical-device-registration-in-new-zealand/

Medical Device Registration in New Zealand - omcmedical.com Ministry of Health: Ministry of Health New Zealand Regulatory Authority: New Zealand Medicines …

Recalls and Corrective Actions - Medsafe

https://www.medsafe.govt.nz/regulatory/devicesnew/8Recalls.asp

Medsafe should be informed as soon as possible and advised of the proposed actions for New Zealand. Drafting a recall action notice As the legal representative of the …

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