The new article explains the approach to be applied with respect to different categories of healthcare products based on specific criteria.
Table of content
The Medicines and Medical Devices Safety Authority (Medsafe), New Zealand’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the regulation of therapeutic products allowed for marketing and use in the country. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
At the same time, the authority reserves the right to make changes to the guidelines and recommendations provided therein, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation. In particular, the guidance provides an overview of the factors used to categorize various products, such as medicines, medical devices, related products, dietary supplements, supplemented foods, cosmetics, or psychoactive substances.
It also includes references to a categorization tool available on the Medsafe website intended to assist the parties involved in making these determinations.
Products at Regulatory Interfaces
The authority acknowledges that determining whether a product falls under the category of a therapeutic product, a type of food, a cosmetic, or a psychoactive substance can be complex. At the same time, correct categorization is essential for identifying the appropriate regulatory framework.
The categorization is based on the product’s intended purpose, ingredients, mode of action, and market presentation through labeling or advertising.
Purpose for Use
Under the general rule, a product intended for therapeutic use is classified as a therapeutic product, regardless of whether therapeutic claims are made. The authority additionally emphasizes that therapeutic claims are not allowed for dietary supplements, herbal remedies, or cosmetics.
Some health claims may be permitted for supplemented foods if they comply with the Australia New Zealand Food Standards Code or the New Zealand Food (Supplemented Food) Standard 2016.
Ingredients
Furthermore, products cannot be legally supplied as cosmetics, related products, dietary supplements, or supplemented foods if they contain ingredients scheduled as Controlled Drugs under the Misuse of Drugs Act 1975 or listed in Schedule 1 of the Medicines Regulations 1984 as Prescription, Restricted (Pharmacist-Only), or Pharmacy-Only Medicines. However, certain medical devices may include such ingredients to assist their primary function.
Medsafe’s searchable classification database can help verify whether an ingredient is scheduled under the Medicines Act, and lists of Controlled Drugs are found in the schedules of the Misuse of Drugs Act 1975.
Mode of Action
The concept of “mode of action” refers to how a product achieves its primary intended effect in or on the human body. If the effect is achieved through a pharmacological, immunological, or metabolic mode of action, the product is classified as a medicine.
If it achieves its effect by other means, it is a medical device. Products with multiple modes of action are primarily classified based on their pharmacological, immunological, or metabolic effects.
Dietary Supplements
Dietary supplements are regulated under the Dietary Supplements Regulations 1985, enabled by the Food Act 2014. A dietary supplement is defined as an edible substance intended to supplement dietary intake.
These products cannot make therapeutic claims. Companies wishing to make such claims must apply for consent to distribute the product as a medicine or related product.
Cosmetics
A cosmetic is defined under Section 2 of the Medicines Act as a substance or mixture used for beautifying, improving, protecting, altering, or cleansing the hair, skin, or complexion. Cosmetics must comply with the requirements of the Cosmetic Product Group Standard administered by the Environmental Protection Authority (EPA).
Examples of such products include:
- Antiperspirants
- Insect Repellents
- Dusting Powders
- Sunscreen and Suntan Preparations (must comply with the Sunscreen (Product Safety Standard) Act 2022 and Australian/New Zealand Standard AS/NZS 2604:2012)
- Skin Cleansers
- Moisturisers
- Hair Conditioners
- Astringents and Skin Toners
- Relaxation Bath Solutions
- Anti-wrinkle and Anti-ageing Products (with superficial cosmetic effects only)
As explained in the document, these products are classified as cosmetics when they are sold without therapeutic claims and do not contain substances listed in the First Schedule to the Medicines Regulations.
Conclusion
In summary, the document outlines the factors influencing the categorization of products and the regulatory requirements for each category, assisting the parties involved in determining the regulatory status of products they are responsible for. The guidance explains the key criteria to be used for categorization and highlights some main aspects to be taken into consideration by the relevant stakeholders.
How Can RegDesk Help?
RegDesk is an AI-powered Regulatory Information Management System that provides medical device companies with regulatory intelligence for over 120 markets worldwide. It can help you prepare and publish global applications, manage standards, run change assessments, and obtain real-time alerts on regulatory changes through a centralized platform. Global expansion has never been this simple.
