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Definition of an exempt device Schedule 1 of the Regulations Interpretation of Schedule 1 In-vitro diagnostic devices Risk classification for IVDs GMDN codes for IVDs Some types of medical devices are exempt from notification to the WAND database. These exemptions are specified in Schedule 1 of the Regulations. The Director-General of Health may also declare certain types of devices exempt.
An exempt device is a medical device, as defined in the Medicines Act 1981, which does not require mandatory notification to the WAND database. Such a device must still comply with all other requirements of the Medicines Act and its associated Regulations. Medsafe should be advised of any post-market action (recall, product correction, alert, field safety notice, etc) conducted for safety reasons associated with exempt devices, in accordance with the Uniform Recall Procedure for Medicines and Medical Devices. See also Explanation of a Medical Device
Schedule 1 of the Medicines (Database of Medical Devices) Regulations 2003 specifies the conditions under which a medical device is exempt from notification to the WAND database, and states; The following are exempt medical devices: any medical device (other than a medical device to which clause 13(2) of Schedule 2 applies) that is also a medicine (within the meaning of section 3(1) of the Act): any medical device that is— manufactured in response to a request by a registered health professional (within the meaning of section 2(1) of the Act) that specifies the design characteristics of the device; and intended to be used only in relation to a particular patient: a medical device supplied to a practitioner (within the meaning of section 2(1) of the Act) for use in relation to a particular patient of the practitioner: any medical device that— has been imported into New Zealand; and is being held by the New Zealand Customs Service pending export from New Zealand to another country: any diagnostic device that is— commonly known as an in vitro diagnostic device; and intended for use only within a particular laboratory: any diagnostic device made in a laboratory that is intended for use in another laboratory (whether or not as a consequence of the purchase of the device by the owner of the other laboratory or otherwise): any medical device imported by a person solely for that person's own use: any medical device imported for use in a clinical trial: any medical device that is included in any class of medical device declared to be an exempt class of medical device by notice issued by the Director-General in the Gazette.
The clauses in Schedule 1 are summarised as meaning the following; Medicines may not be notified to WAND. Medical devices manufactured to the specifications of a healthcare practitioner for a particular patient are exempt Medical devices supplied to a healthcare professional for use in relation to a particular patient of that healthcare professional are exempt Medical devices in transit through New Zealand and under control of the New Zealand Customs Service are exempt Laboratory developed tests (LDTs), or in-house tests, are exempt Laboratory developed tests (LDTs) supplied to another laboratory are exempt A medical device imported by a person solely for that person's use only is exempt Medical devices imported for use in a clinical trial are exempt Types of medical devices may be declared to be exempt by the Director-General of Health by notice in the Gazette.
The Director-General of Health declared IVDs to be exempt from notification to the WAND database under Schedule 1(i) of the Regulations on 12 December 2003. The following notice appeared on the Gazette of 18 December 2003, and came into effect on 1 January 2004. Exemption Medical Devices (in vitro Diagnostic Devices) Notice (No. 1) 2003 I declare the following class of medical device to be an exempt class of medical device for the purposes of the Medicines (Database of Medical Devices) Regulations 2003: Any diagnostic device that is commonly known as an in vitro diagnostic device. For the purposes of this notice, an in vitro diagnostic device means: "any device which is- a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination with other diagnostic devices for in vitro use; and intended by the manufacturer to be used in vitro for the examination of specimens (including blood and tissue donations) derived from the human body: solely or principally for the purpose of giving information about a physiological or pathological state or a congenital abnormality; or to determine safety and compatibility with a potential recipient." I make this declaration pursuant to paragraph (i) of Schedule 1 of the Medicines (Database of Medical Devices) Regulations 2003. This declaration comes into effect on 1 January 2004. Dated at Wellington this 12th day of December 2003. DR KAREN O. POUTASI, Director-General of Health.
Currently, Medsafe does not recognise any IVD risk classification model and has therefore established a single risk classification for all IVDs. Risk classification is selected from a drop down list of options when notifying a device. When notifying IVDs to the WAND database sponsors should use the risk classification of IVD.
Global Medical Device Nomenclature (GMDN) codes are required to be used to identify types of medical devices notified to the WAND database. The GMDN system includes a wide range of codes specific to IVDs. Manufacturers of IVDs should be able to provide sponsors with the correct GMDN codes for their devices. Sponsors should obtain both the 5-digit code and descriptor for the GMDN code from the manufacturer.