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Medicines Amendment Act was passed in 2013 and addresses some problematic provisions of the Medicines Act, including outdated definitions of medicine, medical device and therapeutic purpose.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:
- preventing, diagnosing, monitoring, alleviating, treating, curing, or compensating for, a disease, ailment, defect, or injury; or
- influencing, inhibiting, or modifying a physiological process; or
- testing the susceptibility of persons to a disease or ailment; or
- influencing, controlling, or preventing conception; or
- testing for pregnancy; or
- investigating, replacing, or modifying parts of the human anatomy
- 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
- achieves, or is likely to achieve, its principal intended action in or on the human body by pharmacological, immunological, or metabolic means; and
- 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
- of a kind or belonging to a class that is declared by regulations to be a medicine for the purposes of this Act; but
- does not include -
- a medical device; or
- any food within the meaning of section 2 of the Food Act 1981; or
- any radioactive material within the meaning of section 2(1) of the Radiation Protection Act 1965; or
- any animal food in which a medicine (within the meaning of paragraph (a) or (b)) is incorporated; or
- any animal remedy; or
- 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
- means any substance or article that -
- 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; and
- 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
- includes a material that -
- is intended to be used in or on human beings for a therapeutic purpose; and
- 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
- 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
- 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
- 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
- means any device, instrument, apparatus, appliance, or other
article that -
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:
- 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.
- 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 |
