Healthtech is a highly regulated sector, with innovations requiring extensive research, development and clinical testing to validate the intended health benefits and meet the often extensive requirements of regulators.
Adding to this, for healthtech firms looking to sell their innovation offshore, regulatory requirements can differ around the world.
Given this complexity, it’s essential that healthtech innovators develop a pathway to meet regulatory requirements in conjunction with their product development and other strategies.
When planning for the research and development of your healthtech product - whether it is a pharmaceutical, device, supplement or digital application - it’s important to understand the potential regulatory requirements that may apply to your innovation.
These regulatory requirements often vary by jurisdiction, and require the development of a strategy to prevent any downstream delays, enable compliance and ensure approval can be obtained without costly revisions.
Considerations that inform a regulatory strategy may include, but are not limited to:
The number and breadth of regulatory considerations depend on the class, risk and complexity of the product - ranging from lower risk (e.g. functional foods) through to highest risk (e.g. implantable devices or novel pharmaceuticals).
Different countries have their own regulatory authorities that define the classification of risk, and this page links to resources covering the regulatory landscape across healthtech markets often targeted by Kiwi companies.
Starting locally, the tables in this section provide links to key resources hosted by the Australian and NZ regulators*, alongside links to further learning and reading covering standards and quality management systems.
*Note - the NZ regulatory frameworks are currently being revised:
1. See this link for an overview of the proposed bill (July 2022)
2. See this link for the latest newsletter update (November 2022)
The Food and Drug Administration (FDA) is the federal regulator for healthtech in the United States (US). As the world’s largest healthcare market, the US will be a focus for many Kiwi healthtech companies who will also need to understand how to negotiate the US regulatory environment.
The FDA maintains some educational resources coverings several regulatory topics, including How to Study and Market your Device and Basics for Industry. NZTE also provide a useful overview and infographic covering the regulatory process for medical devices in their selling healthcare solutions in the US article.
For a specific focus on the regulation of drugs, the FDA's Guidance, Compliance & Regulatory Information page covers topics relevant to the development of pharmaceuticals and other bioactive products.
To further understand how FDA requirements can influence the regulatory pathway for product development, reviewing the following documents covering regulatory considerations across several healthtech sectors - including links to other resources - may help:
Europe is also a large, attractive market for many Kiwi healthtech companies. In the European Union (EU), the European Medicines Agency (EMA) and Notified Bodies are involved in evaluating the quality, safety and efficacy of therapeutics alongside other individual EU member state authorities.
In the United Kingdom (UK), the regulatory requirements and authorisation of therapeutic products is the responsibility of the Medicines and Healthcare products Regulatory Agency (MHRA).
The EU, UK and many other markets may also have specific regulatory requirements for components of a healthtech product that need to be considered, with examples being the EU’s Radio Equipment Directive and General Data Protection Regulation (GDPR).
The tables in this section provide further links to key resources from the European and UK regulators. You can also view the HTA’s June 2022 webinar on European Market Access for Medical Devices on the HTA webinars page.
The nature of innovation is that it is ‘new’. That means it can be difficult to understand what different regulatory frameworks might apply to the technology you’re developing, what specific requirements need to be met, and how.
To illustrate some regulatory pathways, we’ve put together some case studies of fictional New Zealand companies developing a range of healthtech innovations aimed at the US market.
Keeping up with regulatory changes can be challenging: to help the HTA maintains a collection of articles, reports, and other useful resources for further reading on global regulatory topics. You can also view recordings of regulatory-related event content on the HTA Webinars page.
Browse more resources on our Articles & Reports page:
From time to time the HealthTech Activator will offer virtual and face-to-face events covering different aspects of the regulatory pathway.Find out more