Local Regulatory Experts
Connect with regulatory affairs consultancies specializing in this region.
Registrar Corp
Hampton, Virginia (HQ), Shenzhen, China, London, United Kingdom, Paris, France, Madrid, Spain, Hyderabad, India, Kuala Lumpur, Malaysia, Tel Aviv, Israel, Guatemala City, Guatemala, Cape Town, South Africa
A global FDA compliance firm assisting businesses in the food, medical device, drug, and cosmetic industries with registration, U.S. Agent services, labeling, and regulatory software solutions.
ARQon Pte. Ltd.
Singapore (HQ), Malaysia, Vietnam, Indonesia, Philippines, Thailand, Taiwan, Hong Kong, South Korea, Switzerland, USA, Australia, New Zealand, Rwanda, India, Sri Lanka
We are a premier regulatory consultancy firm specializing in medical devices, in-vitro diagnostics (IVD), and pharmaceuticals. Founded in 2014, the company offers a comprehensive suite of services ranging from product development strategy and clinical trials to product registration and post-market surveillance. With a team of experts possessing vast experience in regulatory authorities and industry, we bridge the gap between scientific innovation and regulatory compliance, ensuring patient safety while fostering medical advancement. The company also provides unique business matching services through its ATTOPOLIS platform and training through the International Medical Device School.
December 16, 2025
Approximately 5 minutes
New Zealand Post-Market Surveillance: Sponsor's Role in Medsafe Vigilance and Adverse Event Reporting
New Zealand Post-Market Surveillance: Sponsor's Role in Medsafe Vigilance and Adverse Event Reporting
Post-Market Surveillance (PMS) is a mandatory and critical aspect of maintaining medical device compliance in New Zealand. Governed by the Medicines Act 1981 and relevant regulations, the system ensures that the safety and performance of all devices listed in the WAND database are continually monitored after market entry. This vigilance is overseen by the National Regulatory Authority, Medsafe.
Sponsor's Core PMS Obligations
The New Zealand Sponsor serves as the manufacturer's local representative and bears the primary responsibility for managing and fulfilling post-market obligations:
- Adverse Event (AE) Reporting: The Sponsor must ensure that all adverse events and complaints that occur in New Zealand are reported promptly to Medsafe. While the device distributor may initiate the reporting of AEs, the ultimate responsibility for submitting the report and assisting with the investigation lies with the Sponsor.
- Recall Management: The Sponsor must implement comprehensive procedures for managing product recalls and supporting/coordinating mandatory recalls as directed by Medsafe.
- Record Keeping: The Sponsor is required to maintain thorough and accurate records of device distribution to enable effective traceability and prompt notification in the event of a recall or safety alert.
Adverse Event Reporting Timelines
Medsafe requires timely submission of reports to ensure public safety. While specific initial reporting timelines (e.g., 2 or 10 days for different severity levels) are detailed in Medsafe guidance, a key requirement is the deadline for the final report:
- Serious Incidents: If an Adverse Event has the potential to cause serious injury or death, a final report detailing the investigation and corrective actions must be submitted to Medsafe within 30 days of the initial report.
Medsafe Regulatory Action
Based on the adverse event reports and ongoing surveillance, Medsafe may take various regulatory actions to mitigate risk, including:
- Initiating or mandating a product recall.
- Issuing a hazard alert or safety notice to healthcare professionals.
- Requesting product modifications or updates to the Instructions for Use (IFU).
- Conducting compliance audits or requesting further technical documentation.
Active and compliant PMS is essential for maintaining the continuous legal supply of medical devices in the New Zealand market.
Related Articles
Approximately 5 minutes
New Zealand Medical Device Registration: The WAND Notification System and Sponsor Role
Medical devices in New Zealand are regulated by **Medsafe** and listed in the **Web Assisted Notification of Devices (WAND)** database *after* commercialization. Unlike many jurisdictions, pre-market approval is generally not required. Foreign manufacturers must appoint a **New Zealand Sponsor** responsible for the WAND listing and maintaining conformity assessment evidence, which includes documentation like **ISO 13485** and approval from a **Reference Country** (e.g., Australia, EU, US).
Approximately 5 minutes
New Zealand Medical Device Classification: GHTF-Based Risk Rules
New Zealand's medical device classification is based on **GHTF guidelines** (similar to Australia/EU), dividing devices into Class I, IIa, IIb, III, and AIMD based on risk factors like invasiveness and duration of use. The classification is determined by applying **22 specific rules** outlined in **Schedule 2 of the Medicines (Database of Medical Devices) Regulations 2003**, starting from the highest risk rule and working backwards.
Approximately 5 minutes
New Zealand Medical Device Advertising: Compliance and Professional Use Restrictions
New Zealand medical device advertising is regulated by the **Medicines Act 1981**, though it lacks a formal review process. Manufacturers are expected to self-comply, ensuring all claims are truthful. Crucially, advertising for devices designated **'professional use only'** must be strictly limited to qualified practitioners and cannot appear on public-facing channels like social media or general publications. All labeling must be in **English**.