For a long time, the market entry for medical products in New Zealand had been operating under a framework with limited regulation. This all changed with the Royal assent of the Therapeutic Products Bill on 26 July 2023, which transformed it into the Therapeutic Products Act (2023). This represents the most significant development in the regulatory landscape for medicines, medical devices and natural health products in the country for almost four decades.
While the majority of the Act’s provisions won’t come into force until mid-2026, it is crucial for medical device manufacturers to familiarise themselves with these impending changes, as they will reshape the very core of the industry. Over the coming months, we’ll be launching a series of articles that will take a closer look at the new legislation, with this introduction serving as a preliminary overview.
Why the New Legislation was Needed
Historically, New Zealand’s approach to the market entry of medical devices could best be described as lenient. The primary mechanism was the registration of these products on the central WAND database by Medsafe. Individuals wishing to enter medical products into this database were simply required to register as a sponsor. However, there was a glaring absence of rigorous professional qualifications for these sponsors; being a resident of New Zealand was the only requirement. Apart from labelling and advertising directives, the system was characterised by a conspicuous absence of in-depth scrutiny, resulting in a regulatory environment that lacked comprehensive market surveillance.
This minimalistic approach raised several concerns:
- Lack of Oversight: Without proper controls in place, the potential for sub-standard or unsafe products entering the market was ever-present.
- Absence of Global Alignment: As international healthcare standards advanced, New Zealand’s existing system lagged, potentially risking the nation’s reputation and the safety of its citizens.
- Limited Regulation of Innovative Therapies: Groundbreaking areas like cell, gene, and tissue therapies remained in a regulatory blind spot, despite their potential impact on healthcare.
- Unregulated Natural Health Products: With a growing global emphasis on natural health and wellness, the lack of clear regulation for these products in New Zealand was a glaring gap.
Given these challenges, and as health technologies evolved at a breakneck pace, the call for change grew louder. The nation needed a framework that was not only robust and comprehensive, but also agile enough to adapt to the rapidly shifting sands of healthcare innovation. The Therapeutic Goods Act 2023 is New Zealand’s answer to these pressing demands, promising a future where safety, innovation and international harmonisation come together.
What the Therapeutic Goods Act Entails for Medical Devices
The Therapeutic Products Act 2023 not only aims to provide a comprehensive framework for the overall therapeutic products landscape in New Zealand, but specifically introduces a number of significant changes for medical devices. The Therapeutic Products Act 2023 combines the dual objectives of safeguarding public health and promoting industry growth and innovation.
Let’s take a closer look at how the Act will affect the medical device sector, looking at the key objectives and major changes to the regulatory environment.
Key Goals of the Act for Medical Devices
At its core, the Therapeutic Products Act 2023 is committed to:
- Ensuring Safety and Quality: By implementing stricter controls, the Act endeavors to ensure that every medical device available to New Zealanders adheres to high standards of safety and performance.
- Promoting Innovation: While safety is paramount, the Act is designed to be flexible enough to support and foster innovation within the medical device industry.
- Aligning with Global Standards: Recognizing the importance of international harmony, the Act is designed to be in sync with global medical device regulatory standards.
- Filling Regulatory Gaps: Given that medical devices and certain advanced therapies were not fully regulated in New Zealand, this Act seeks to address and rectify this oversight.
Pivotal Changes for Medical Devices
The Act introduces several transformative changes for medical devices:
- Market Authorisation Process: The previous regime allowed devices to be registered after being in New Zealand for up to 30 days. The new Act mandates that devices cannot enter the market without prior authorization, signaling a more proactive regulatory stance.
- Clear Distinction between Manufacturers: One of the novel introductions of the Act is the differentiation between the manufacturer and the responsible manufacturer, with added clarity for those utilizing device production systems or involved in remanufacturing devices.
- Heightened Qualification Standards: With an intent to maintain impeccable standards throughout the device lifecycle, the Act stipulates enhanced qualification, training, and competency requirements for everyone in the supply chain.
- Revised Sponsorship Regulations: Sponsors play a pivotal role in the medical device ecosystem, and the Act introduces a dedicated subsection outlining their duties, obligations, and provisions.
- Reclassification of Modified Devices: In a move to ensure that significant modifications to devices undergo rigorous scrutiny, any major change to an approved device necessitates a fresh approval, essentially categorizing it as a new product.
Implications for Medical Device Manufacturers
In the wake of the Therapeutic Products Act 2023, medical device manufacturers find themselves navigating a transformed regulatory landscape. The new terrain is marked with challenges but also laden with opportunities. Here’s a breakdown of what the future may hold for these manufacturers:
- Product Purpose Clarification for New Zealand Market
Manufacturers, especially those with products currently exclusive to the New Zealand market, need to ensure they correctly and thoroughly define the intended purpose of their products. This definition determines the classification and market authorization process for the product.
Implication: A clear and accurate understanding and description of a product’s purpose are vital for the appropriate regulatory process.
- Enhanced Scrutiny and Accountability
With the introduction of the Market Authorisation Process and increased qualification standards, manufacturers will need to be even more diligent. Each device will be subject to rigorous scrutiny before it enters the market, and manufacturers will be held more accountable for the safety, quality and efficacy of their products.
Implication: Manufacturers will likely need to invest more in research, quality assurance, and compliance processes to ensure their products meet the enhanced regulatory standards.
- Clearer Definitions and Responsibilities
The Act’s clear distinction between a manufacturer and the responsible manufacturer, as well as definitions related to device modifications, provides manufacturers with a clearer understanding of their roles and responsibilities.
Implication: This clarity can streamline internal processes, but also demands a heightened sense of responsibility, especially for those involved in remanufacturing or making significant modifications to existing devices.
- Opportunity for Innovation
While the Act introduces stricter regulations, its flexibility in encouraging innovation is a silver lining. Manufacturers are now incentivised to explore new frontiers in medical device technology, knowing that there’s a supportive framework that values innovation.
Implication: Companies that prioritise research and development may find themselves at a competitive advantage, given the Act’s emphasis on supporting innovative solutions.
- Global Alignment and Market Expansion
Aligning with international standards opens doors for New Zealand’s medical device manufacturers to expand their reach. With products that adhere to global standards, the potential for international market penetration increases.
Implication: Manufacturers can look to global markets with greater confidence, but this also means they need to keep abreast of international regulatory changes to maintain this alignment.
- Training and Development Focus
Given the Act’s emphasis on qualifications, training and competence throughout the supply chain, manufacturers will need to prioritise the ongoing professional development of their teams.
Implication: This may lead to initial investment in training programmes and workshops, but will likely result in a workforce that’s more skilled and adept at navigating the nuances of medical device manufacturing and distribution.
- Engaging with Sponsors
The revised regulations around sponsorship mean that overseas manufacturers will need to foster close collaborations with sponsors, ensuring they’re aligned in their understanding and adherence to the Act’s provisions.
Implication: This may require manufacturers to revisit and possibly renegotiate agreements with sponsors to ensure compliance with the new regulatory framework.
Conclusion: The Road Ahead for Medical Device Regulation in New Zealand
The Therapeutic Products Act 2023 marks a significant milestone in New Zealand’s healthcare regulatory environment. For medical device manufacturers, this legislation is a clear indicator of the direction in which industry standards are heading: higher benchmarks, but with an acknowledgement of the importance of innovation and global synchronicity. Those manufacturers who are proactive and prioritise quality, innovation and training will be better placed to respond to this evolving landscape.
The key takeaway for medical device manufacturers is to identify their specific role within the system. They need to determine whether they are a manufacturer, responsible manufacturer, sponsor, importer or exporter. This distinction not only determines the range of obligations they must meet, but also the qualifications required of their personnel.
The full picture of this regulatory shift is still emerging. Until 2026, Manatū Hauora will be dedicated to developing the necessary underpinnings of the Act. This will include drafting detailed rules, fine-tuning regulations and establishing the basic framework for the regulator. Given these ongoing developments, it is evident that the regulatory environment is in a transitional phase.
Looking ahead, the implementation of the Act is segmented into three primary initiatives:
- Secondary Legislation: This encompasses the development of precise policies, rules, and regulations to bolster the new therapeutic regulatory regime. It is noteworthy that these aspects are slated for consultation, emphasizing a collaborative approach.
- IT Infrastructure: Central to the Act’s operational success will be a resilient IT platform, designed to cater to the emerging demands and ensuring scalability.
- The Regulator: A crucial element will be the appointment of an independent authority, fortified by a dedicated business unit within the Ministry of Health, tasked with administering the Act.
It is vital for stakeholders, particularly manufacturers, to stay informed and engaged during this period of regulatory evolution. As these developments continue, we’ll keep you updated on the changing landscape of healthcare regulation in New Zealand.
If you have any questions about the Therapeutic Products Act (2023), please don’t hesitate to contact Johner Institute New Zealand. We’re here to help.