Australian regulatory guidelines for medical devices

t Australian regulatory guidelines for n medical devices e (ARGMD) Historical docum Version 1.1, May 2011

Therapeutic Goods Administration

About the Therapeutic Goods Administration (TGA)

? The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and Ageing, and is responsible for regulating medicines and medical devices.

? The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance), when necessary.

t ? The work of the TGA is based on applying scientific and clinical expertise to decision-making, to

ensure that the benefits to consumers outweigh any risks associated with the use of medicines

n and medical devices. e ? The TGA relies on the public, healthcare professionals and industry to report problems with

medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action.

m ? To report a problem with a medicine or medical device, please see the information on the TGA Historical docu website.

Copyright ? Commonwealth of Australia 2011

This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to .

Australian Regulatory Guidelines for Medical Devices V1.1 May 2011

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Therapeutic Goods Administration

Version history

Version Description of change

Effective date

V1.0 V1.1

Initial publication

? Updated references and contact details to reflect TGA's new organisational structure post TGA21

ent 28/04/10

04/05/11

? Made multiple amendments and additions in Section 3. Essential Principles, Principle 14--Clinical Evidence.

? Made multiple amendments in Section 22. Post-market vigilance

m and monitoring requirements. u ? Added a fourth part titled `Navigation and Reference' that

includes:

c ? a bibliography

? consolidated contact details ? an index

o ? a glossary of terms d ? Made various punctuation and grammar amendments Historical ? Reformatted for compliance with new TGA style manual

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Therapeutic Goods Administration

Contents

Part 1?Introduction

16

Section 1. Introduction to the regulatory guidelines 17

t Purpose of the ARGMD______________________________________________________ 17

n Scope of the ARGMD _________________________________________________________ 17

e Legislation applying to medical devices _________________________________ 18

MDSOs and CASOs________________________________________________________________________ 18

Medical device advisory committees_____________________________________ 19

m What is a medical device? __________________________________________________ 19

u How medical devices are regulated in Australia _______________________ 20

Key elements of the medical device regulatory scheme ______________ 21

c Life-cycle approach to the regulation of a medical device ___________ 24

o Who is the manufacturer of a medical device __________________________ 25

Responsibilities of a medical device manufacturer ___________________________________ 25

d Who is the sponsor of a medical device__________________________________ 26

l Responsibilities of a medical device sponsor__________________________________________ 27

Processes to supply medical devices in Australia _____________________ 27

a Process to supply a medical device in Australia--all Class I non-

sterile and non-measuring devices_______________________________________ 29

ic Process to supply a medical device in Australia--if the medical

device is manufactured in Australia _____________________________________ 30

r Process to supply a medical device in Australia--if the medical o device is manufactured overseas _________________________________________ 31

tProcess to supply a medical device in Australia--if the device

contains a medicine or materials of animal, microbial recombinant,

isor human origin______________________________________________________________ 32

Currency of information____________________________________________________ 33

HSection 2. Fees and charges for medical devices

34

Overview ______________________________________________________________________ 34 Annual charges_______________________________________________________________ 34

Low-value turnover ______________________________________________________________________ 35

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Therapeutic Goods Administration

Fees ____________________________________________________________________________ 35

Application fees __________________________________________________________________________ 35

C Conformity assessment fees __________________________________________________________ 36

ent Application audit fees____________________________________________________________________ 37

Fee reductions _______________________________________________________________ 37

Payment of fees by instalments ___________________________________________ 37

Section 3. The Essential Principles

39

Overview ______________________________________________________________________ 39

General principles ________________________________________________________________________ 39 Principles about design and construction _____________________________________________ 39 Demonstrating compliance with the Essential Principles ____________________________ 40

m Standards _________________________________________________________________________________ 40 u Standards orders _________________________________________________________________________ 41

Risk management ________________________________________________________________________ 41

c Meeting the Essential Principles--General Principles________________ 42 o Principle 1--Use of medical devices not to compromise health and safety ________ 42

Principle 2--Design and construction of medical devices to conform with safety

d principles _________________________________________________________________________________ 43

Principle 3--Medical devices to be suitable for intended purpose __________________ 43

l Principle 4--Long-term safety__________________________________________________________ 44

Principle 5--Medical devices not to be adversely affected by transport or storage45

a Principle 6--Benefits of medical devices to outweigh any undesirable effects ____ 45 ic Meeting the Essential Principles--Principles about design and

construction __________________________________________________________________ 45

r Principle 7--Chemical, physical and biological properties __________________________ 45

Principle 8--Infection and microbial contamination _________________________________ 49

oPrinciple 9--Construction and environmental properties ___________________________ 52 tPrinciple 10--Medical devices with a measuring function___________________________ 53

Principle 11--Protection against radiation____________________________________________ 54

isPrinciple 12--Medical devices connected to or equipped with an energy source _ 56 Principle 13--Information to be provided with medical devices ___________________ 62

H Principle 14--Clinical evidence_________________________________________________________ 67

Principle 15--Principles applying to IVD medical devices only _____________________ 73

Section 4. Classification of medical devices

74

Overview ______________________________________________________________________ 74

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Therapeutic Goods Administration

Principles for applying the classification rules ________________________ 75

Medical devices with a measuring function_____________________________ 76

Examples of medical devices and whether they have a measuring function _______ 77

ent Medical devices required to be sterile ___________________________________ 77

Classification Rule 1--Transient, short-term, and long-term use __ 82 Classification Rule 2--Non-Invasive Medical Devices_________________ 83 Classification Rule 3--Invasive Medical Devices_______________________ 86 Classification Rule 4--Active medical devices__________________________ 93

Classification Rule 5--Special Rules _____________________________________ 97

Classification examples____________________________________________________101

m Section 5. Conformity assessment overview

105

u What is conformity assessment of a medical device? ________________105

Types of conformity assessment evidence _____________________________108

c Manufacturers who must have a TGA Conformity Assessment

Certificate ____________________________________________________________________109

o What is the manufacturer responsible for? ____________________________110

d What is the Australian sponsor responsible for? _____________________110

l Section 6. What a manufacturer needs to know about

conformity assessment

112

a Overview _____________________________________________________________________112 ic Conformity assessment procedures for each class of medical device112

Conformity assessment procedures_____________________________________114

r Part 1 Full quality assurance procedures (excluding Clause 1.6)___________________118

Part 1, Clause 1.6 Examination of design______________________________________________ 118

oPart 2 Type examination procedures__________________________________________________119 tPart 3 Verification procedures _________________________________________________________119 isPart 4 Production quality assurance procedures ____________________________________ 120

Part 5 Product quality assurance procedures ________________________________________ 120

Part 6 Declaration of conformity (not requiring assessment by Secretary)

H procedures _______________________________________________________________________________121

Part 7 Medical devices used for a special purpose ___________________________________ 122

Part 8 Clinical Evaluation procedures _________________________________________________ 122

TGA Conformity Assessment Certificates _____________________________________________ 123

Pre-submission meetings_______________________________________________________________123

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Therapeutic Goods Administration

Documentation for applications _______________________________________________________ 124

Manufacturers of devices containing materials of human blood or plasma derivatives, animal, microbial, or recombinant origin; or medicinal substances _ 125

MRA certificates of conformity issued by the TGA ___________________________________126

On-site audits ____________________________________________________________________________126 Applications for certificates ____________________________________________________________126

t TGA processing of applications ________________________________________________________ 129

Issue of certificates______________________________________________________________________129

n Changes to current certificates ________________________________________________________ 130

e Conditions on certificates ______________________________________________________________ 131

Suspension and revocation of certificates ____________________________________________ 132

Surveillance _________________________________________________________________133

m Recertification ______________________________________________________________133

u Declarations of Conformity _______________________________________________134

Section 7. What a sponsor needs to know about

c conformity assessment

135

o Overview _____________________________________________________________________135 d Conformity assessment evidence accepted by the TGA ______________136

Conformity assessment evidence not accepted by the TGA _________136

l TGA Conformity Assessment Certificates _____________________________________________137 a MRA certificates of conformity accepted by the TGA_________________137

What information should be on an MRA certificate?_________________________________ 138

ic EC certificates issued by an EU Notified Body _________________________140 What information should be on an EC certificate ____________________________________ 142 r Annex to EC certificate__________________________________________________________________143

o Manufacturer's Evidence __________________________________________________144 Submitting Manufacturer's Evidence__________________________________________________144 tMaintaining currency of Manufacturer's Evidence___________________________________ 145

isNext steps ____________________________________________________________________146

Section 8. Differences between the Australian and

HEuropean Union medical device regulatory requirements147

Overview _____________________________________________________________________147

Regulatory frameworks ________________________________________________________________ 147 In vitro diagnostic devices______________________________________________________________ 147

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Therapeutic Goods Administration

Australian sponsor and European authorised representative ______________________ 147

Identification of sponsor and authorised representative ___________________________ 148

Conformity assessment procedures ___________________________________________________ 148

ent Declarations of conformity _____________________________________________________________148

Australian Register of Therapeutic Goods (ARTG) and CE marking________________ 148 Global Medical Device Nomenclature (GMDN) system ______________________________ 149 Retention of records ____________________________________________________________________ 149

Differences between Australian Essential Principles and EU Essential Requirements ___________________________________________________149

Devices with different requirements in Australia and the EU ______153

Hip, knee, and shoulder joint replacements __________________________________________ 153

Definition of central circulatory system ______________________________________________ 153

m Devices for recording x-ray images____________________________________________________154

u Active implantable medical devices and accessories ________________________________ 154

Medical devices that are considered machinery _____________________________________ 155

c Medical devices that are considered personal protective equipment ______________ 155

Medical devices intended for disinfecting, cleaning, etc_____________________________155

o Medical gas and connection systems __________________________________________________ 155

d Devices with radio-communication transmitters and/or that connect to

telecommunications networks_________________________________________________________156

l Medical devices that connect to public mains electricity networks ________________156

Medical devices incorporating a medicinal substance_______________________________156

a Medical devices containing substances of animal origin ____________________________ 157

Medical devices containing gelatine and collagen____________________________________ 157

ic Medical devices containing tissues, cells, or substances of microbial or recombinant

origin _____________________________________________________________________________________ 157

r Medical devices containing mercury __________________________________________________157

Medical devices containing nanomaterials ___________________________________________ 157

oReprocessing of single-use medical devices __________________________________________ 158

tMedical devices intended for export only_____________________________________________158

isSpecial/particular procedure for systems and procedure packs ___________________ 158

Certification of sterilisation providers ________________________________________________ 158

HSection 9. International agreements

159

Overview _____________________________________________________________________159

Types of international agreements______________________________________160

Current international agreements ______________________________________160

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