Categorisation of Products http://www.medsafe.govt.nz/Regulatory/categorisation-of-products.asp

1. Revised: 1 July 2014
Categorisation of Products
This guide has been prepared to help companies understand the factors that determine the category under which a product is
regulated.
The categorisation of a product is determined by its ingredients, its purpose for use and the manner in which it is presented in
the market.
Ingredients
Products categorised as dietary supplements, supplemented foods, cosmetics, or related products are not permitted to contain
ingredients scheduled as Controlled Drugs under the Misuse of Drugs Act 1975 or scheduled as prescription medicines,
restricted (pharmacist-only) medicines or pharmacy-only medicines under the Medicines Act 1981.
Medsafe's searchable database can be used to check whether an ingredient is scheduled under the Medicines Act. When
searching for a substance in the schedule remember to check synonyms if the initial seach gives a "not found" result.
Lists of Controlled Drugs can be found in Schedules at the end of the Misuse of Drugs Act.
Purpose for use
Therapeutic claims are not permitted for products supplied as dietary supplements, supplemented foods or cosmetics.
Independent advice is available on whether a claim implies a therapeutic purpose. The Association of New Zealand
Advertisers offers a Therapeutic Advertising Pre-vetting Service (TAPS). For a fee an adjudicator will assess labels and
advertising material and advise if it is compliant with NZ legislation. TAPS also offer advice on how statements could be
modified to avoid non-compliance with the Medicines Act 1981. Alternatively there are a number of regulatory affairs
consultants who specialise in advertising compliance. A list is available on this web site.
Another useful resource is the TAPS website. This website contains some guidelines on therapeutic claims and provides
examples of claims that do not imply a therapeutic purpose.
Other sources of information
Distributors wishing to import unprocessed plant or animal material, should contact NZ Biosecurity to determine which import
standards apply.
The New Zealand Customs Service is also able to advise on the requirements for commercial importation.
Copies of all the New Zealand Acts and Regulations discussed above may be downloaded for free from
www.legislation.govt.nz
The following can be used to determine the appropriate regulatory coverage for a product.
Categorisation of Products http://www.medsafe.govt.nz/Regulatory/categorisation-of-prod...
1 of 5 2/7/2557 14:54

2. Categorisation Guidance
The following table provides categorisation information for various types of product.
The examples that have been selected for inclusion in the table are illustrative of product types that will change categorisation
from 1 July 2014 or product types that lie close to the medicine / medical device interface.
Product Type Category
(from 1 July 2014)
Absorbable intra-ocular and synovial visco-elastic fluids used in surgery Medical device
Artificial tears or saliva
Blood bags with / without anticoagulant / preservative
Bone cement with antibiotic
Catheter with heparin / antibiotic coating
Contact lens lubricants and solutions
Condoms with spermicide / viricide / local anaesthetic
Cryogenic gases
Dental cement with antibiotic / adrenaline
Dermal Fillers (e.g. collagen injections) with / without local anaesthetic included in the formulation
Douches for body "cleaning"
Haemodialysis solutions
Haemostatic agents - collagen and non-medicated Medical device
Haemostatic agents - fibrin Medicine
Hormone eluting intra-uterine contraceptive devices Medicine
Injectable contrast agents for use in diagnostic imaging (e.g PET, CAT, NMR, X-Ray, Ultra-sound) Medicine
Intra-uterine contraceptive devices other than hormone eluting IUCDs (includes copper containing
IUCDs)
Medical device
Categorisation of Products http://www.medsafe.govt.nz/Regulatory/categorisation-of-prod...
2 of 5 2/7/2557 14:54

3. Product Type Category
(from 1 July 2014)
In-vitro pregnancy tests
Irradiating apparatus
Lubricating gels with / without local anaesthetic included in the formulation
Manuka honey dressings provided the action of the honey is not described as being an antibiotic /
antibacterial
Medicated dressings where the primary purpose of the dressing is to cover and protect the wound and
provide an environment that supports healing (in contrast to being a delivery mechanism for the
medication).
Peritoneal dialysis solutions and substances Medicine
Procedure kits (no medicines included) Medical device
Procedure kits which include an approved medicine in its original pack Medical device
Saline nasal sprays Medical device
Saline for injection Medicine
Solutions for irrigation Medical device
Tamponade solutions for eye surgery Medical device
Tissue adhesives (including fibrin based) Medical device
Toothpastes for sensitive teeth where the mode of action is physical (e.g by blocking open pores).
Fluoride content (if any) must be no greater than that allowed in a general sales medicine
Medical device
Total Parenteral Nutrition (TPN) solutions Medicine
Transdermal patches Medicine
Vascular balloons with / without medicinal coating Medical device
Urea ointment for nail debridement Medical device
Ultrasonic therapy apparatus Medical device
Water for injection Medicine
Requesting a Product Categorisation from Medsafe
If assistance is required in determining whether a product is a medicine or a medical device the sponsor of the product should
collate the following information and submit this to Medsafe together with their request for the categorisation status of the
product.
Name and contact details of the sponsor
Name and location details of the manufacturer
Name of the product
A description of the purpose of the product
Information about the mode(s) of action of the product
A description of the form of the product
Information about any regulatory approvals the product has from other regulators or notified bodies including;
The name of the regulator/notified body
The type of approval granted (CE Mark, FDA 510k, FDA Pre Market Assessment, TGA Registration or Inclusion,
etc)
A copy of the promotional material for the product
URL of a website detailing the product
A copy of the product label
Medsafe may also request further information about the product in order to make a decision.
The above information should be submitted to Medsafe by one of the following methods;
Electronically - by email to devices@moh.govt.nz
Courier - to Medsafe, Level 6, 10 Brandon Street, Wellington, 6011
Post - to Medsafe, PO Box 5013, Wellington, 6145
Definitions
Categorisation of Products http://www.medsafe.govt.nz/Regulatory/categorisation-of-prod...
3 of 5 2/7/2557 14:54

4. Therapeutic Purpose
Therapeutic purpose - means any of the following purposes, or a purpose in connection with any of the following purposes:
preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating for, a disease, ailment, defect, or injury;
or
a.
influencing, inhibiting, or modifying a physiological process; orb.
testing the susceptibility of persons to a disease or ailment; orc.
influencing, controlling, or preventing conception; ord.
testing for pregnancy; ore.
investigating, replacing, or modifying parts of the human anatomyf.
Medicine -
means any substance or article that -
is manufactured, imported, sold, or supplied wholly or principally for administering to 1 or more human beings for a
therapeutic purpose; and
i.
achieves, or is likely to achieve, its principal intended action in or on the human body by pharmacological,
immunological, or metabolic means; and
ii.
a.
includes any substance or article -
that is manufactured, imported, sold, or supplied wholly or principally for use as a therapeutically active ingredient in
the preparation of any substance or article that falls within paragraph (a); or
i.
of a kind or belonging to a class that is declared by regulations to be a medicine for the purposes of the Medicines
Act; but
ii.
b.
does not include -
a medical device; ori.
any food within the meaning of section 2 of the Food Act 1981; orii.
any radioactive material within the meaning of section 2(1) of the Radiation Protection Act 1965; oriii.
any animal food in which a medicine (within the meaning of paragraph (a) or (b)) is incorporated; oriv.
any animal remedy; orv.
any substance or article of a kind or belonging to a class that is declared by regulations not to be a medicine for the
purposes of the Medicines Act
vi.
c.
Medical Device -
means any device, instrument, apparatus, appliance, or other article that -
is intended to be used in, on, or for human beings for a therapeutic purpose; andi.
does not achieve its principal intended action in or on the human body by pharmacological, immunological, or
metabolic means (but may be assisted in its function by such means); and
ii.
a.
includes a material that -
is intended to be used in or on human beings for a therapeutic purpose; andi.
does not achieve its principal intended action in or on the human body by pharmacological, immunological, or
metabolic means (but may be assisted in its function by such means); and
ii.
b.
also includes -
anything that is intended to be used with a device, instrument, apparatus, appliance, article, or material referred to
in paragraph (a) or (b) to enable the device, instrument, apparatus, appliance, article, or material to be used as its
manufacturer intends; and
i.
any device, instrument, apparatus, appliance, article, or material of a kind or belonging to a class that is declared by
regulations to be a medical device for the purposes of the Medicines Act; but
ii.
c.
does not include a device, instrument, apparatus, appliance, article, or material of a kind or belonging to a class that is
declared by regulations not to be a medical device for the purposes of the Medicines Act
d.
Related Product
A related product is defined in the Medicines Act 1981. A related product is a cosmetic or dentifrice or food in respect of
which a claim is made that the substance or article is effective for a therapeutic purpose. It does not include any medicine.
A product that is used "wholly or principally" for a therapeutic purpose is a medicine. A related product has a therapeutic
purpose that is not its principal purpose (e.g. a fluoride toothpaste, where the principal purpose is to clean the teeth).
Categorisation of Products http://www.medsafe.govt.nz/Regulatory/categorisation-of-prod...
4 of 5 2/7/2557 14:54

5. Many products at the food-therapeutic product interface are likely to be related products (e.g. a capsule containing vitamins
and minerals where the principal purpose is to supplement the dietary intake of those substances).
Supplemented Food
Supplemented foods are regulated under the Food Act 1981 and are subject to the NZ Food (Supplemented Food)
Standards 2010.
The standards can be downloaded from www.foodsafety.govt.nz.
Dietary Supplement
Dietary supplements are regulated under the Food Act 1981 and are subject to the Dietary Supplements Regulations 1985
(administered by Medsafe). These regulations specify a number of requirements for dietary supplements relating to matters
such as composition, labelling and maximum permitted daily doses for many vitamins and minerals.
Cosmetic
A product is a cosmetic if it is used to beautify, cleanse or protect the hair, skin. teeth or complexion.
Refer to the Cosmetic Products Group Standard 2006, published by the Environmental Protection Authority (EPA) under the
Hazardous Substances and New Organisms (HSNO) legislation.
This group standard includes lists of chemicals whose use in cosmetics is restricted.
It is available from www.epa.govt.nz
Refer also to regulations 22, 24 and 26-36 of the Medicines Regulations 1984 for requirements that apply to cosmetics.
"Therapeutic type" Dose Form
A therapeutic type dose form is a presentation of the product in a form generally used in pharmaceuticals such as tablets,
capsules and controlled amounts of oral liquids or powders.
A product is considered a supplemented food if it is represented as a food that has a substance or substances added to it or
that has been modified in some way to perform a physiological role beyond the provision of nutritive requirement.
Home | About this Site | ANZTPA | FAQs | Site Map | Contact Us
Categorisation of Products http://www.medsafe.govt.nz/Regulatory/categorisation-of-prod...
5 of 5 2/7/2557 14:54