(Total Views: 152)
Posted On: 03/02/2025 9:53:12 PM
Post# of 8439
New Zealand
The "Web Assisted Notification of Devices" (WAND) is a database managed by Medsafe where all medical devices sold in New Zealand must be listed.
Based on available information, ActiPatch is listed on the Medsafe WAND database in New Zealand; meaning it is officially notified to the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) as a medical device available in the country.
Regulatory compliance:
By being listed on WAND, it indicates that ActiPatch complies with New Zealand's medical device regulations.
Australia
TGA approval:
Before a product can be listed on the ARTG, it must go through a review process by the TGA to ensure its quality, safety, and efficacy.
Regulation:
Any therapeutic good, including pain relief patches like ActiPatch, must be listed on the ARTG to be legally sold in Australia.
Sponsor requirement:
Companies wishing to sell a medical device in Australia typically need to appoint an Australian sponsor to handle the registration process.
ActiPatch is not listed on the Australian Register of Therapeutic Goods (ARTG), meaning it is not currently approved for sale in Australia by the Therapeutic Goods Administration (TGA).
The "Web Assisted Notification of Devices" (WAND) is a database managed by Medsafe where all medical devices sold in New Zealand must be listed.
Based on available information, ActiPatch is listed on the Medsafe WAND database in New Zealand; meaning it is officially notified to the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) as a medical device available in the country.
Regulatory compliance:
By being listed on WAND, it indicates that ActiPatch complies with New Zealand's medical device regulations.
Australia
TGA approval:
Before a product can be listed on the ARTG, it must go through a review process by the TGA to ensure its quality, safety, and efficacy.
Regulation:
Any therapeutic good, including pain relief patches like ActiPatch, must be listed on the ARTG to be legally sold in Australia.
Sponsor requirement:
Companies wishing to sell a medical device in Australia typically need to appoint an Australian sponsor to handle the registration process.
ActiPatch is not listed on the Australian Register of Therapeutic Goods (ARTG), meaning it is not currently approved for sale in Australia by the Therapeutic Goods Administration (TGA).
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