MedSafe Medical Device Registration in New Zealand
ANSWERED ON THIS PAGE:
- Is pre-market authorization required for medical devices in New Zealand?
- How are medical devices classified in New Zealand?
- Do foreign manufacturers need an in-country representative to sell their medical devices in New Zealand?
In order to commercialize your product in New Zealand's small yet well-developed medical device market, you must meet requirements set up by the country's medical device regulator, the Medicines and Medical Device Safety Authority (MedSafe).
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 your product in MedSafe's Web Assisted Notification of Devices (WAND) database within 30 days of commercialization. Before your device is listed in WAND, you must ensure you have documentation that proves your device's safety and effectiveness (such as certification from an EU Notified Body, Health Canada or US FDA) because MedSafe may request such information.
Medical device classification in New Zealand
New Zealand uses a classification system based on risk to the human body. Increasing risk is assigned to Classes I (self-certified, sterile, or measuring), IIa, IIb, III, and AIMD respectively. New Zealand uses a set of rules to determine classification. This system is closely aligned with the EU and Australian model, and classifications under this system will reflect that in the EU, in most cases.
New Zealand in-country representation for foreign medical device companies
Companies that do not have a physical presence in New Zealand must appoint a Sponsor to list a device in WAND. The New Zealand Sponsor maintains responsibility for the accuracy of the information in WAND and is the sole liaison to Medsafe. Similar to the Australian regulatory system, the New Zealand system places vigilance responsibility on the New Zealand Sponsor.
Emergo can help you start selling your medical device in New Zealand
Emergo has listed hundreds of medical devices in New Zealand's WAND database. We can also assist you in preparing all necessary documents to address any information requests from MedSafe. Here's how we can help:
- Act as your New Zealand Sponsor via our colleagues in Auckland.
- List your devices with MedSafe before they are marketed and notify MedSafe of any changes.
- Keep your Technical File/Design Dossier ready and available for inspection by MedSafe. We will only release this information to MedSafe with your written approval.
- Assist in incident reporting to MedSafe, in close liaison with you and distributors.
- Notify MedSafe as to which investigations are to be conducted.
- Assist in device recall.
- Keep at the disposal of MedSafe the report concerning the critical evaluation of all data collected during the clinical evaluation.
- Act as your primary regulatory contact with MedSafe, including notifications of incidents and complaints reported to MedSafe.
Emergo is fully equipped to help you access the New Zealand medical device market. Your success in New Zealand is our goal.
Do WAND listings expire?
Device listings in New Zealand do not expire. However, devices that are deemed to pose an unacceptable risk to the public can be removed from the market.
What information is required to submit our WAND medical device listing?
WAND listing includes the following information:
- Risk classification of the device
- Manufacturer's contact information
- Global Medical Device Nomenclature (GMDN) Code
- Intended purpose of the device