DISCLAIMER
This document is provided for guidance only. The classification examples provided might vary if
a manufacturer assigns a different intended purpose to that used for the examples. Manufacturers
and sponsors must use the Classification Rules, as contained in the Therapeutic Goods (Medical
Devices) Regulations 2002, to classify their medical devices.
Please refer to the Therapeutic Goods Act, 1989 as amended by the Therapeutic Goods
Amendment (Medical Devices) Bill, 2002 and the Therapeutic Goods (Medical Devices)
Regulations, 2002 for legislative requirements.
FURTHER INFORMATION
The Medical Devices Information Unit of the Office of Devices, Blood and Tissues of the
Therapeutic Goods Administration (TGA) can be contacted by:
Telephone:
Facsimile:
Email:
Website:
Mail:
1800 141 144
(02) 6232 8299
cab.medical.device.information@health.gov.au
http://www.tga.gov.au/devices/devices.htm
PO Box 100
Woden
ACT 2606
©
Commonwealth of Australia 2005
2
AMENDMENT SCHEDULE
Version
Number
Date of
Amendment
Summary of Amendments
3
CONTENTS
Disclaimer ..............................................................................................................................................2
Further Information................................................................................................................................2
Amendment Schedule............................................................................................................................3
Introduction............................................................................................................................................6
Purpose ...................................................................................................................................................6
Background ............................................................................................................................................6
The classes of medical devices..............................................................................................................6
The classification rules ..........................................................................................................................7
Classifying a medical device.................................................................................................................7
Deciding what classification rules apply.......................................................................................7
Important points to remember .......................................................................................................8
Flowchart 1- deciding what classification rules apply .................................................................9
FLOWCHART 2 CLASSIFICATION RULES - NON INVASIVE DEVICES...........................10
RULE 2 NON INVASIVE MEDICAL DEVICES...................................................................11
Rule 2.1 Non-invasive medical devices – general ......................................................................11
Rule 2. 2 Non-invasive devices intended to channel or store blood, etc ...................................11
Rule 2.3 Non-invasive devices intended to modify the biological or chemical composition of
blood, etc.......................................................................................................................................12
Rule 2.4 Non-invasive devices intended to have contact with injured skin ..............................12
FLOWCHART 3 CLASSIFICATION RULES - INVASIVE DEVICES.....................................13
FLOWCHART 3A CLASSIFICATION RULES - INVASIVE DEVICES..................................14
RULE 3 INVASIVE MEDICAL DEVICES.............................................................................15
Rule 3.1 Invasive devices intended to be used to penetrate body orifices.................................15
Rule 3.2 Surgically invasive devices intended for transient use ................................................15
Rule 3.3 Surgically invasive devices intended for short-term use .............................................16
Rule 3.4 Surgically invasive devices for long-term use and implantable devices ....................17
FLOWCHART 4 CLASSIFICATION RULES - ACTIVE DEVICES ..........................................18
RULE 4 ACTIVE MEDICAL DEVICES .................................................................................19
Rule 4.1 Active medical devices – general .................................................................................19
Rule 4.2 Active medical devices for therapy ..............................................................................19
Rule 4.3 Active medical devices for diagnosis ...........................................................................20
Rule 4.4 Active medical devices intended to administer or remove medicines, etc from a
patient’s body................................................................................................................................20
FLOWCHART 5 CLASSIFICATION RULES –Special rules........................................................21
RULE 5 SPECIAL RULES ........................................................................................................22
Rule 5.1 Devices incorporating a medicine.................................................................................22
Rule 5.2 Devices for contraception or prevention of sexually transmitted diseases .................22
4
Rule 5.3 Devices intended for disinfecting, cleaning, rinsing etc ..............................................22
Rule 5.4 Non-active devices intended to record X-ray diagnostic images................................22
Rule 5.5 Devices containing non-viable animal tissues or derivatives......................................22
Rule 5.6 Devices that are blood bags...........................................................................................23
Rule 5.7 Active implantable medical devices .............................................................................23
Rule 5.8 Medical devices for export only ...................................................................................23
Rule 5.9 Devices that are mammary implants ............................................................................23
APPENDIX A - Definitions..............................................................................................................24
Accessory ...................................................................................................................................24
Active implantable medical device ...........................................................................................24
Active medical device ................................................................................................................24
Active medical device for diagnosis ..........................................................................................24
Active medical device for therapy .............................................................................................24
Ancilliary action .........................................................................................................................25
Biological effect .........................................................................................................................25
Body orifice .................................................................................................................................25
Central circulatory system ..........................................................................................................25
Central nervous system................................................................................................................25
Chemical change ........................................................................................................................25
Direct diagnosis ...........................................................................................................................26
Duration ......................................................................................................................................26
Implantable medical device .......................................................................................................26
Integral ........................................................................................................................................26
Intended purpose ........................................................................................................................26
Invasive medical device ..............................................................................................................26
Measuring function ......................................................................................................................26
Medical device ...........................................................................................................................27
Potentially hazardous .................................................................................................................27
Reusable surgical instrument .....................................................................................................27
Surgically invasive medical device ............................................................................................27
Vital physiological process ........................................................................................................28
Wholly or mainly absorbed .........................................................................................................28
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INTRODUCTION
This guidance document is one of a series produced to assist a wide-ranging audience to
understand the regulatory system for medical devices in Australia that commenced on 4 October
2002. The system has been established by the Therapeutic Goods Act, 1989 and the Therapeutic
Goods (Medical Devices) Regulations, 2002.
Although each guidance document has been developed to provide information about particular
aspect of the medical devices regulatory system in Australia, it is expected that a certain amount of
cross-referencing to other documents in the series will be inevitable.
PURPOSE
The purpose of this document is to provide guidance on the classification rules for medical devices
and relates to the following segments of the medical device legislation.
? Section 41BD of the Therapeutic Goods Act 1989 (the Act)
? Regulation 3.2 of the Therapeutic Goods (Medical Devices) Regulations 2002 (MD
Regulations).
? Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002.
? Dictionary – Therapeutic Goods (Medical Devices) Regulations 2002.
BACKGROUND
The risks associated with using medical devices can range from little or no risk to patients and
users to significant potential risks inherent in the type of device. The level of premarket
intervention by the regulator is proportional to the level of potential risk and is established through
a classification system based on that potential risk.
The classification risk is determined from:
! the manufacturer’s intended purpose for the medical device, and
! a set of classification rules. These rules will classify medical devices into one of five classes of
medical devices.
THE CLASSES OF MEDICAL DEVICES
The five classes of medical device based upon the classification rules are:
! Class I- for low risk medical devices
- includes low risk devices that are sterile and /or have a measuring function
! Class IIa - for low-medium risk medical devices,
! Class IIb - for medium–high risk medical devices,
! Class III - for high risk medical devices, and
! AIMD- for Active Implantable Medical Devices (are treated as Class III medical devices).
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THE CLASSIFICATION RULES
Schedule 2 of the MD Regulations describes the classification rules that apply to:
! Non-invasive medical devices (Rule 2):
?General (Rule 2.1),
?Device to channel or store blood (Rule 2.2),
?Device to modify biological or chemical composition of blood (Rule 2.3), and
?Device to contact with injured skin (Rule 2.4).
!
Invasive medical devices (Rule 3):
?Device used to penetrate body orifices (Rule 3.1),
?Surgically invasive device for transient use (Rule 3.2),
?Surgically invasive device for short-term use (Rule 3.3), and
?Surgically invasive device for long-term use and implantable devices (Rule 3.4).
Active medical devices (Rule 4):
?General (Rule 4.1),
?Active device for therapy (Rule 4.2),
?Active device for diagnosis (Rule 4.3), and
?Active devices to administer or remove medicines from a patient’s body (Rule 4.4).
Special rules for medical devices:
?Device incorporating a medicine (Rule 5.1),
?Device for contraception or prevention of sexually transmitted disease (Rule 5.2),
?Device for disinfecting, cleaning another medical device (Rule 5.3),
?Non-active device to record X-ray diagnostic images (Rule 5.4),
?Device containing animal tissues, cells or other substances, that will need to be rendered
non-viable to mitigate any infectivity risk or microbial or recombinant tissues, cells or
other substances (Rule 5.5),
?Device that is a blood bag (Rue 5.6),
?Active implantable device (Rule 5.7),
?Device for export only (Rule 5.8), and
?Device that is a mammary implant (Rule 5.9).
!
!
CLASSIFYING A MEDICAL DEVICE
DECIDING WHAT CLASSIFICATION RULES APPLY
The following decisions need to be made before applying the classification rules:
! Is the product a medical device? Check the definition of a medical device on page 27,
! Do the special classification rules (Schedule 2, Part 5 of the MD Regulations) apply? See
Flowchart 5- Special rules on page 21,
! Is the device intended to be non-invasive? See Flowchart 2 on page 10,
(NB- If the device is sterile or has a measuring function conformity evidence will be needed),
! Is the device intended to be invasive through a body orifice? See Flowchart 3 on page 13,
! Is the device intended to be surgically invasive? See Flowchart 3A on page 14, or
! Is the device an active medical device? See Flowchart 4 on page 18.
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IMPORTANT POINTS TO REMEMBER
!
!
The manufacturer is responsible for determining the class of a device.
The classification rules are based on the manufacturer’s intended purpose, taking into account
the mechanism of action, and in some cases, more than one rule can apply. If this happens, the
higher classification applies with the exception of medical devices for export only (Rule 5.8)
which are classified as Class I.
All the relevant classification rules must be considered to determine the class of the medical
device.
The classification must be consistent with the information accompanying the medical device
including the label, directions for use, brochures and operating manuals.
If the intended purpose is not clear in the information, the TGA will assume an intended
purpose consistent with the purpose generally accepted in clinical practice.
If the device is to be used in combination with another medical device, the classification rules
must be applied separately to each device.
Accessories are classified separate to the medical device they are used with.
The duration for use must be specified for all invasive medical devices.
If the device is not for use in a specific part of the body, its classification is based on the most
critical specified use.
Software intended to drive or influence the use of a medical device falls under the same
classification as the medical device.
Based on the intended purpose, software may be a medical device in its own right.
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