Medical Device Regulatory Seminar by bigbubbamust


									Medical Device Regulatory Seminar

   Proposed Requirements for In-vitro
          Diagnostic Devices

      Thursday 2 December, 2004

                                   Trevor Nisbet
  In-Vitro Diagnostic Devices

Medsafe:   Marilyn Anderson
           Derek Fitzgerald
           Trevor Nisbet
           Barbara Cavanagh
           Becci Slyfield

TGA:       Shelley Tang
           Robyn Wood
                       Structure of Medsafe

    • Medicines Act 1981/Misuse of Drugs Act 1975


Business Development
   & Support Team       Compliance Team             Evaluation Team   Medicine Control Team
         Trans-tasman Agency

• The Joint Scheme will
  – Introduce legislation based on international
    best practice
  – Improve protection of public health and safety
  – Faciliate trade and closer economic relations
    between Australia and New Zealand
              Progress to Date

1. New interim legislation:

  •   Medicines (Database of Medical Devices)
      Regulations 2003
  •   Established a notification database of medical
      devices in New Zealand known as WAND (Web
      Assisted Notification of Devices)
  •   In-Vitro Diagnostic devices currently exempted
      from WAND
                Purpose of WAND
• To identify NZ sponsors and manufacturers of devices
  imported or manufactured in New Zealand
• System is a notification scheme not an approval scheme
• Information being collected is based on the
  recommendations of the Global Harmonisation Task Force
• Information collected will allow the devices to be
  continued to be supplied to New Zealand for a transition
  period after the Joint Agency is formed.
• After the transition period devices will be required to
  comply with the Joint Agency requirements.
            WAND Database
      Information being recorded:
•   Name and address of NZ sponsor

•   Name and address of manufacturer

•   Device classification – Class 1, IIa, IIb etc

•   Global Medical Device Nomenclature Code (GMDN

•   Purpose of the device

•   Manufacturing evidence (optional)
    Information recorded on WAND
          on 22 October 2004
Number of sponsors registered:   250

Number of sponsors submitted:    151

Device Notifications:            6365

   – AIMD        -   166
   – Class III   -   477
   – Class IIb   -   765
     Device Incident Reporting Form
• See Medsafe website –
     Device Incident Reporting Form
• See Medsafe website –
          Device Recalls / Complaints

                    Investigated   Device             Diagnostic
                                   recalls/upgrades   recalls/upgrades
1 July 2003 to 30   471            190                64
June 2004

1 July 2004 to 26   161            64                 15
November 2004
           Current New Zealand system
                 controlling IVDs
•   Medicines Act 1981 defines a pregnancy test as a medicine.

•   Any diagnostic test administered to a person is controlled under the
    Act as a medicine eg barium meal.

•   All other in-vitro diagnostic tests are classified as devices.

•   Concerns especially wth home use IVD devices for serious diseases –
    eg HIV kits.

•   Section 58(1) d of the Medicines Act 1981 states that no person shall
    publish an advertisement inviting correspondence on the sending of
    hair, blood, urine or bodily specimens or photographs for the purpose
    of diagnosis or treatment of a condition.
   Proposed Joint Agency – July 2005
• Current legislation to be replaced by rules

• Proposed scheme has been developed by TGA and
  Medsafe to control IVD’s

• This seminar is to give information on proposed scheme
  to control IVD’s before drafting rules become available

• Industry will be able to comment on the drafting rules
           Definition of In Vitro
            Diagnostic Device
IVDs can be described as test kits and
instruments used to carry out testing on human
samples, where the results are intended to
assist in clinical diagnosis or in making decisions
concerning clinical management.

To top