Published: 28 May 2014

Medicines

Important Changes to the Definition of Medicines and Medical Devices Effective 1 July 2014

In New Zealand medicines and medical devices are regulated under the Medicines Act 1981 and its associated regulations.

Currently, some products that are considered to be medical devices by other regulators may be categorised as medicines in New Zealand as a consequence of the legal definitions currently contained within the Medicines Act 1981.

The Medicines Amendment Act was passed in 2013 and addresses some problematic provisions of the Medicines Act, including outdated definitions of medicine, medical device and therapeutic purpose.

What are the changes relating to definitions?

The Act modernises the definitions of medicine, medical device and therapeutic purpose in order to better align the boundary between medicines and medical devices with international norms. These changes come into effect on 1 July 2014.

Internationally, medical devices are typically distinguished from medicines by considering their mode of action rather than their physical form. A medical device:

  • Does not achieve its principal intended action by pharmacological, immunological or metabolic means (but may be assisted in its function by such means)

The revised definitions enable products such as pregnancy tests and contact lens solutions to be categorised as medical devices.

The new definitions are:

  • Therapeutic purpose - means any of the following purposes, or a purpose in connection with any of the following purposes:
    1. preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating for, a disease, ailment, defect, or injury; or
    2. influencing, inhibiting, or modifying a physiological process; or
    3. testing the susceptibility of persons to a disease or ailment; or
    4. influencing, controlling, or preventing conception; or
    5. testing for pregnancy; or
    6. investigating, replacing, or modifying parts of the human anatomy
  • Medicine -
    1. means any substance or article that -
      1. is manufactured, imported, sold, or supplied wholly or principally for administering to 1 or more human beings for a therapeutic purpose; and
      2. achieves, or is likely to achieve, its principal intended action in or on the human body by pharmacological, immunological, or metabolic means; and
    2. includes any substance or article -
      1. 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
      2. of a kind or belonging to a class that is declared by regulations to be a medicine for the purposes of this Act; but
    3. does not include -
      1. a medical device; or
      2. any food within the meaning of section 2 of the Food Act 1981; or
      3. any radioactive material within the meaning of section 2(1) of the Radiation Protection Act 1965; or
      4. any animal food in which a medicine (within the meaning of paragraph (a) or (b)) is incorporated; or
      5. any animal remedy; or
      6. 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 this Act
  • Medical Device -
    1. means any device, instrument, apparatus, appliance, or other article that -
      1. is intended to be used in, on, or for human beings for a therapeutic purpose; and
      2. 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
    2. includes a material that -
      1. is intended to be used in or on human beings for a therapeutic purpose; and
      2. 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
    3. also includes -
      1. 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
      2. 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 this Act; but
    4. 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 this Act

What does this mean?

As a result of the changes, from 1 July 2014:

  • There will be some products currently regulated as medicines that will be re-categorised as medical devices. This means that they will no longer need consent to be sold in New Zealand but they will need to be notified on the WAND database (as required by the Medicines (Database of Medical Devices) Regulations 2003) by Monday 11 August 2014. For guidance, a table of some affected products is reproduced at the end of this document.
  • There are some medical equipment products which are currently exempt from the regime under the Medicines Act which will be covered (as medical devices) as a result of the changes to the definitions. These are ultrasonic therapy apparatus used by physiotherapists 1 and irradiating apparatus 2.

What do sponsors need to do?

Sponsors are requested to:

  1. Review their product portfolio to identify which products will be categorised as medical devices from 1 July 2014 and notify these on Medsafe's WAND database. This notification is required by the Medicines (Database of Medical Devices) Regulations 2003 and must be completed by Monday 11 August 2014 (i.e within 30 working days after becoming a medical device sponsor on 1 July). There is no fee to enter a device onto the WAND database.
  2. Provide Medsafe with a list of the medicinal products which the sponsor believes have been re-categorised as medical devices. Medsafe will check that list and where Medsafe agrees that a product meets the new definition of medical device, it will update its SMARTI database record for the product and issue a "closure" database report to confirm the change of categorisation.

    In cases where Medsafe considers a product continues to meet the definition of medicine, it will advise the sponsor why it does not agree with its re-categorisation assessment.

What is Medsafe going to do?

Inform sponsors

In addition to the interactions with Sponsors noted above, Medsafe will update its website and the New Zealand Regulatory Guidelines on the website effective from 1 July 2014. The website will include an updated categorisation process to assist sponsors to classify their products.

Pending applications

For pending applications (both NMAs and CMNs), in respect of products that are medicines now but will become devices on 1 July, there will be a refund of most of the application fee if Medsafe has not yet started to evaluate the application. If that is the case, Medsafe will retain $1000 as an administration fee and refund the remainder. If Medsafe has commenced evaluation there will be no refund.

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
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

 

If you are still unsure how to categorise your product, please send information on the product to askmedsafe@health.govt.nz

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