Understanding the regulatory landscape

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.

Meeting regulatory requirements

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 country 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 evidence required to make desired health claims
  • Demonstration of product safety and efficacy
  • Adherence to standards relevant to the product category and its elements
  • Implementation of a quality management system
  • Adherence to good manufacturing and laboratory practice

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 being revised:
The Therapeutic Products Act (2023) will be repealed - read the latest updates on the Ministry of Health's website.

Meeting US regulatory requirements

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:

A scientist working with test equipment in a lab.

Meeting European regulatory requirements

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.

  • For medicinal products, regulatory approval requires either an EMA assessment for centralised marketing authorisation by the European Commission (as is the case for the majority of new, innovative medicines), or national authorisation (most generics and non-prescription medicines)
  • For medical devices, the regulatory process is managed by member state Notified Bodies and is dependent on the type of device. Based on risk, a marketing authorisation (CE certificate) may require Notified Bodies to consult expert panels, the EMA or a national competent authority  

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.  

Regulation in action

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.

Case studies

Health IT – Disease Management App

Health IT – Disease Management App

Learn more about how the Diabetologic team, which is developing a smartphone app that helps diabetic and pre-diabetic patients control their lifestyle and improve diabetic control, is rolling out its service to patients in the US.
Topical Adhesive - Consumer Skin/Wound

Topical Adhesive - Consumer Skin/Wound

Learn more about a medical device company that wants to sell a topical adhesive in the US market as a consumer skin/wound adhesive, after achieving a CE mark in Europe for the same product.
Wearable Device for Oxygen Saturation

Wearable Device for Oxygen Saturation

Learn more about OxyResp, which is developing a wearable device that measures a person’s circulating oxygen saturation and is wanting to access the US market.
Total Ankle Replacement Device

Total Ankle Replacement Device

Learn more about an early-stage medical device company that wants to sell a total ankle replacement device for primary or revision surgery in the US market.

Find out more

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.

Latest Resources

Browse more resources on our Articles & Reports page:

Browse more