Australia TGA Approval recognized by New Zealand?

tehuff

Involved In Discussions
#1
I have been unable to confirm that an Australian TGA approval is accepted by New Zealand via a Mutual Recognition Agreement - I ran across this somewhere, but cannot find a definitive source. So here I am on the Cove!:D Does anyone know the answer? Thanks!
 
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Ajit Basrur

Staff member
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#2
I have been unable to confirm that an Australian TGA approval is accepted by New Zealand via a Mutual Recognition Agreement - I ran across this somewhere, but cannot find a definitive source. So here I am on the Cove!:D Does anyone know the answer? Thanks!
The Mutual Recognition Agreement (MRA) on standards and conformity assessment between Australia and the European Community (EC) was signed in Canberra on 24 June 1998 and came into effect on 1 January 1999. The MRA covers eight industry sectors of which the Therapeutic Goods Administration (TGA) has responsibility for two; medicinal products GMP inspection and batch certification, and medical devices conformity assessment.

The EC-MRA applies to medical devices manufactured in the European Community, Australia and New Zealand.

It is defined in the AGREEMENT ON MUTUAL RECOGNITION IN RELATION TO CONFORMITY ASSESSMENT, CERTIFICATES AND MARKINGS BETWEEN THE EUROPEAN COMMUNITY AND AUSTRALIA

The detailed scope is mentioned in the TGA News -

The agreement applies to therapeutic goods manufactured in Australia, New Zealand and the European Community (Belgium, Denmark, Germany, Greece, Spain, France, Ireland, Italy, Luxembourg, the Netherlands, Austria, Portugal, Finland, Sweden and the United Kingdom).

The agreement does not cover products exported to or imported from Norway, Iceland, Liechtenstein and Switzerland. These countries belong to the European Free Trade Association (EFTA). However, Australia is negotiating an MRA with these countries. When this is finalised, the MRA will cover all countries included in the European Economic Area (EEA).
 
M

MIREGMGR

#3
While the MRA in question is an important agreement, I don't see how it addresses the OP's question regarding NZ recognition of a TGA approval. NZ only figures in the cited MRA obliquely, and as far as I know wasn't even a signatory.

This document speaks to the question starting on page 195. However, it may not be definitive because (supposedly) there was a subsequent report, which I haven't been able to track down.

This earlier document is relevant in that it clearly defines the exemptions to be focused solely in the pharma and bio areas.
 
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tehuff

Involved In Discussions
#5
Thanks for the info. It appears that the Australia New Zealand Therapeutic Goods Authority is defunct. Their website is marked historical and I can't find any new information. If anyone has their product on both the AU and NZ markets, please let me know if NZ has special requirements. Thanks!
 
Z

zhang126

#6
New Zealand legislation does not require pre-market assessment of medical devices; however, a Sponsor of a medical device in New Zealand must notify the device to the Web Assisted Notification of Devices (WAND) database within 30 days of becoming the sponsor.
A company submitting a tender to supply devices for public health is required to demonstrate that the device is already approved for use in Australia or the US, or is CE marked.
The notification system called “New Zealand Web Assisted Notification of Devices” (NZ WAND) is the only regulatory system in New Zealand. The Medicines (Database of Medical Devices) Regulations 2003 came into force on 1 January 2004. These Regulations require the Director General of Health to maintain a database ("WAND") of all medical devices supplied in New Zealand.
From that date, a Sponsor (i.e. any New Zealand-based person or organization that is manufacturing or importing medical devices for supply in New Zealand) will be required to enter details into a medical device database within 30 days of commencing supply of a new medical device.
The information required in general is:
• manufacturer’s information
• device identification, conformity certification and evidence
• sponsor’s information
The notification of a device to the WAND database does not constitute approval or endorsement of the safety or efficacy of a medical device by Medsafe or any other regulatory body.
 
A

Adele

#8
Further to zhang126 comments, you are not obligated to submit any form of manufacturer's evidence on WAND. The WAND requirement is purely a notification of products sold in NZ.

Separately from the requirement of listing on the WAND database, NZ hospitals require evidence of the listing as the database is not publically searchable, as well as Australian ARTG numbers, EC certification and 510(k) certificates before they will use the product.

The WAND listing and the information on overseas approvals for hospitals can occur separately .
 
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