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 1, 2025
Approximately 5 minutes
New Zealand Medical Device Advertising: Compliance and Professional Use Restrictions
New Zealand Medical Device Advertising: Compliance and Professional Use Restrictions
Medical device advertising and promotion in New Zealand are regulated under the Medicines Act 1981 and associated regulations, which are overseen by Medsafe. While the regulatory environment does not include a formal pre-vetting or review process for advertisements, manufacturers and Sponsors are fully expected to comply with the legal requirements, ensuring all promotional claims are truthful, balanced, and substantiated.
Definition of Advertising
Under Section 56 of the Medicines Act 1981, "advertisement" is broadly defined to include any form of written, printed, spoken, or visual communication used to promote the sale of medical devices or endorse a treatment method. This definition extends to:
- Trade circulars and journals.
- Product labels.
- Online and social media communication.
- Newspapers, periodicals, and broadcasting.
Restrictions on Professional Use Devices
A critical requirement is the restriction on advertising devices designated for professional use:
- Target Audience: Advertising for devices designated 'professional use only' must be strictly limited to qualified practitioners.
- Public Mediums: Such products cannot be advertised on public mediums, including social media, general magazines, or public websites, as this constitutes unlawful promotion to the general public.
Compliance requires careful channel management to ensure promotional materials only reach the intended professional audience.
Labeling Requirements
In addition to advertising rules, the TGA-aligned labeling requirements must be met to ensure products are legally supplied.
- Language: All medical device labeling in New Zealand must be in English.
- Alignment: Labeling requirements are largely harmonized with international standards, such as the GHTF (Global Harmonization Task Force) guidelines.
Compliance with both the advertising restrictions and mandatory labeling requirements is essential for maintaining the legal status of medical devices listed in the WAND database.
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 Post-Market Surveillance: Sponsor's Role in Medsafe Vigilance and Adverse Event Reporting
Post-Market Surveillance (PMS) is mandatory in New Zealand under the **Medicines Act**, requiring the **New Zealand Sponsor** to manage adverse event reporting and recalls. While distributors primarily report incidents, the Sponsor is responsible for ensuring all **Adverse Events (AEs)** are reported to Medsafe promptly. For incidents with the potential to cause serious injury or death, a final report must be submitted within **30 days** of the initial report.