New Zealand Medical Device Regulations

Log into RAMS to download the documents listed below along with more regulations and guidances for New Zealand.

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Major Regulations
Document Number Published Language
Log in Medicines Regulations 1984 1984 English
Log in Medicines Act of 1981 118 10/1981 English
General Guidance Documents
Document Number Published Language
Log in Exemption Medical Devices (In Vitro Diagnostic Devices) Notice (No. 1) 2003 2003 English
Log in Medicines (Database of Medical Devices) Regulations 2003 SR 2003/325 11/2003 English
Specific Guidance Documents
Document Number Published Language
Log in New Zealand Medicines and Medical Devices Recall Code English
Log in User Guide for WAND English
Log in Guideline on the Regulation of Therapeutic Products in New Zealand, Part 1 - Overview of Therapeutic Product Regulation English