Medical Devices
Web Assisted Notification of Devices (WAND)
About the Medicines (Database of Medical Devices) Regulations 2003
Letter sent to device suppliers in November 2003
Wellington
6 November, 2003
To: Medical Device Manufacturers, Importers, Exporters and Distributors
ESTABLISHMENT OF A NEW MEDICAL DEVICE NOTIFICATION DATABASE
The purpose of this letter is to:
- advise you of new medical device regulations expected to come into force on 1 January 2004;
- explain the establishment and purpose of the Web-Assisted Notification of Devices (WAND) database; and
- advise you of the steps towards implementation of the new regulations.
New Medical Device Regulations
On 1 January 2004, it is expected that the Medicines (Database of
Medical Devices) Regulations 2003 will come into force.
From that date, a sponsor (i.e. any New Zealand-based person or organisation that is manufacturing or importing medical devices for supply in New Zealand, or exporting medical devices) will be required to enter details into a medical device database within 30 days of commencing supply or export of a new medical device.
For existing medical devices (i.e. those that were being supplied in New Zealand or exported prior to 1 January 2004 and are still being supplied or exported), sponsors will have a period of one year to complete a notification on the database.
The Medical Device Notification Database
A new database is being established for notifying medical devices. The
database is called WAND (Web-Assisted Notification of Devices). WAND is a
secure electronic database that will be accessed from the Medsafe web site. A
brief description of the WAND database is enclosed with this letter.
A device sponsor will be required to enter information such as device class, name and description, sponsor details and manufacturer details on the database. There will also be provision for details of the conformity assessment certification for the device to be entered, if available, but this will not be mandatory.
Sponsors will be required by law to enter medical device details onto the database. This will progressively create a record of medical devices on the New Zealand market, facilitating post-market surveillance activities such as recalls and responding to safety alerts. It would also facilitate transition to the planned joint regulatory agency with Australia.
WAND is a notification database only. The existence of an entry in the database does not in any way indicate that the medical device has undergone any evaluation or been approved by Medsafe for distribution in New Zealand.
The database will not be accessible to the public. Sponsors will be able to print entries for their own products and provide copies to other parties if they wish to do so. Requests to Medsafe for information relating to entries in the database will be treated as requests under the Official Information Act.
Sponsors of medical devices already on the Australian Register of Therapeutic Goods (ARTG) will be able to have the relevant information transferred electronically from the TGA's DEAL database into the WAND database so that no additional data entry will be required.
Training seminars for the medical device industry
Medsafe will be holding training seminars for the medical device industry
at which the WAND database will be demonstrated and more detailed information
provided on using the database.
Training seminars will be held as follows:
Wellington
Venue: Copthorne Hotel, Wellington Plimmer Towers Date: Tuesday 25 November 2003 Time: 9:00 am - 12:00 noon (Coffee available from 8.30 am)
Auckland
Venue: Waipuna Hotel and Conference Centre, Mt Wellington Date: Wednesday 26 November 2003 Time: First session: 9:30 am-12:30 pm (Coffee available from 9.00 am) Second session: 2 pm-5 pm (Coffee available from 1.30 pm)
If you wish to attend a training seminar, please RSVP to:
becci_slyfield@moh.govt.nz Phone (04) 496 2155
by Friday 14 November 2003, indicating which session you wish to attend.
The WAND database will "go live" from 1 January 2004. However, a practice version of the database will be available from the time of the training seminars until 24 December 2003. Instructions on accessing the database during this practice period will be provided at the training seminars. A help-desk service will be available for those requiring assistance.
Yours sincerely
Susan Martindale
Team Leader, Business Development and Support