Regulation of Clinical Tests: In Vitro Diagnostic (IVD) Devices ...
Medical Devices (IVDs) - application process...Medical devices (IVD) – application process Session...
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Medical devices (IVD) – application process
Session Chair ― Wendy-Jane Morrow Chief Executive Officer, IVD Australia Speakers / Panelists ― Euan Miller Assistant Director, Therapeutic Goods Administration Chris Harwood Assistant Director, Therapeutic Goods Administration Karen MacLeod Business Manager, Diagnostics, MP Biomedicals Australasia Pty Ltd
Medical Devices (IVDs)
Applications for ARTG inclusion
Euan Miller Application and Verification Section Medical Devices Branch Devices Sponsor Information Day
15 October 2015
Purpose
Facilitate better understanding of the regulatory requirements for IVD medical
devices
ARTG inclusion – explain the process and give some examples
Session 3B – Medical Devices (IVDs) - Application process 3
What is a medical device? • Used for human beings • Intended purpose
– Diagnose, prevent, monitor, treat or alleviate disease or compensate for injury or disability
– Investigation, replacement or modification of anatomy or physiological processes – Control conception – Accessory to a medical device as described above
• Is to be ascertained from the information provided on or in any one or more of the following: - Labelling - Instructions for use - Any manufacturer’s advertising material relating to the product - Technical documentation
Therapeutic Goods Act 1989, section 41BD
Session 3B – Medical Devices (IVDs) - Application process 4
In vitro diagnostic (IVD) medical device
• A reagent, calibrator, control material, kit, specimen receptacle, instrument, software, equipment or system
• Intended for the in vitro examination of human specimens for
- giving information about a physiological or pathological state - giving information about a congenital abnormality - determining safety and compatibility with a potential recipient - monitoring therapeutic measures
Dictionary, Therapeutic Goods (Medical Devices) Regulations 2002
Session 3B – Medical Devices (IVDs) - Application process 5
Examples
Session 3B – Medical Devices (IVDs) - Application process 6
Types of IVD medical devices • Intended to be used by:
– health professionals in the laboratory
– health professionals at the point of care
– lay-person (self-testing)
• Does not include Research Use Only (RUO) or Analyte Specific Reagents (ASR)
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ARTG inclusion • Any IVD medical device must be included in ARTG
- Transitional provisions ended on 30 June 2015 • Except:
- Devices for which effective applications for inclusion in the ARTG were submitted before the end of transitional period but not yet finalised
- In-house IVD medical devices (transitional provisions until 30 June 2017)
• Sponsor is responsible for ARTG inclusion Session 3B – Medical Devices (IVDs) - Application process 8
Before you start • TGA Business Services (TBS)
- Register and get your Client ID
Session 3B – Medical Devices (IVDs) - Application process 9
Important Classification based on the intended purpose
and level of risk of the device
Conformity assessment procedures
Essential principles for safety and performance
Post-market monitoring
Session 3B – Medical Devices (IVDs) - Application process 10
Process for ARTG inclusion
Session 3B – Medical Devices (IVDs) - Application process 11
Manufacturer Evidence • Manufacturer must apply appropriate conformity assessment
procedure to the device (quality management system and control over the design of the device)
• Sponsor must lodge the manufacturer’s certification of the conformity assessment with the TGA - Except for Class 1 IVD
Acceptable certificates- TGA conformity assessment certificate - EC Certificate issued in accordance with IVDD 98/79/EC - ISO 13485 (CMDCAS ISO 13485 or IAF ISO 13485)
Session 3B – Medical Devices (IVDs) - Application process 12
Manufacturer Evidence
ACCEPTED −What does it mean?
Go to the next step - lodging application for ARTG inclusion
Session 3B – Medical Devices (IVDs) - Application process 13
Application for ARTG inclusion • Must be made for a kind of device and
• Must be effective - Made in accordance with a form and manner
approved (via TBS) - Application fee is paid - For Class 4 IVD – conformity assessment certificate
must be issued by the TGA for the device - Must not contain information that is false or
misleading in a material particular Session 3B – Medical Devices (IVDs) - Application process 14
Matters certified must be correct medical device
intended purpose
correctly classified
essential principles and availability of information to substantiate compliance
application of conformity assessment procedure and availability of information
requirements (if any) relating to advertising
prohibited imports
excluded purposes
information in or with the application is complete and correct
Therapeutic Goods Act 1989, section 41FD 15
Common questions
Kind of device
Intended purpose
Classification
Conformity assessment procedure
GMDN code Session 3B – Medical Devices (IVDs) - Application process 16
Kind of device
a medical device is taken to be of
the same kind as another medical device if they
have the same:
• Sponsor • Manufacturer • Device nomenclature system code
(GMDN) • Classification • Unique product identifier
(for Class 4 IVDs)
Therapeutic Goods Act 1989, section 41BE and Therapeutic Goods (Medical Devices) Regulations 2002, regulations 1.6 and 1.7
Session 3B – Medical Devices (IVDs) - Application process 17
Examples of the kinds of devices
• Blood glucose monitoring system (BGMS) (including strips) AND test strips AND controls
These devices are of the same kind
• BGMS (excluding strips) AND test strips AND controls
X These devices are not of the same kind
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Intended purpose of a kind of device • Means the purpose for which the manufacturer of the
device intends it to be used, as stated in the information provided with the device (labeling, instructions for use, advertising material and technical documentation)
• Intended purpose stated in the application must be consistent with the purpose for which the manufacturer intends the devices of the kind to be used
- specific versus general
- 500 characters only (in the application)
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IVD medical devices are classified having regard to the intended purpose of the device
and its risk to public health and/or personal risk
RISK
• Class 1 IVD – no public health risk or low personal risk
• Class 2 IVD – low public health risk or moderate personal risk
• Class 3 IVD – moderate public health risk or high personal risk
• Class 4 IVD – high public health risk Therapeutic Goods (Medical Devices) Regulations 2002, division 3.1 and schedule 2A
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Classification (Schedule 2A)
Rule 1.1 Class 4
Rule 1.2 Class 3 /4
Rule 1.3 Class 3
Rule 1.4 self-
testing
Rule 1.5 QC
Rule 1.6 Class 1
Rule 1.7 Class 2
Rule 1.8 Class 1 Export only
Session 3B – Medical Devices (IVDs) - Application process 21
Classification examples • Class 1 IVDs
- Microbiological culture media; instruments/analysers
• Class 2 IVDs - Pregnancy self-tests, H&E stain
• Class 3 IVDs - sexually transmitted diseases; genetic tests
(inc. FISH) • Class 4 IVDs
- screen blood donors for HIV & HCV; ABO
22 Session 3B – Medical Devices (IVDs) - Application process
Common questions • Pathogens listed on the Australian National Notifiable
Disease Surveillance System (NNDSS) list • Human genetic testing • Patient selection* for:
i. selective therapy and management ii. disease staging iii. diagnosis of cancer
*An IVD medical device would fall into Class 2 IVD if
a) a therapy decision would usually be made only after further investigation; or
b) the device is used for monitoring Session 3B – Medical Devices (IVDs) - Application process 23
Conformity assessment procedure Declaration of conformity
- To be provided with the application:
Class 3 IVDs
- Must be made in accordance with Schedule 3 of the Therapeutic Goods (Medical Devices) Regulations 2002
- Must contain correct information (including Certificate number appropriate for the device)
- Templates available
Session 3B – Medical Devices (IVDs) - Application process 24
Global Medical Device Nomenclature (GMDN)
• GMDN code - one of the characteristics that defines the kind of device - is to be consistent with the intended purpose of the device
• Depends on Class of IVD device - relevant preferred term or - Level 1, Level 2 or Level 3 collective term (CT)
Manufacturer’s responsibility
Session 3B – Medical Devices (IVDs) - Application process 25
GMDN examples
IVD medical device GMDN
HIV1/HIV2 antigen IVD, kit, immunochromatographic test (ICT) rapid
[30832]
Human immunodeficiency viruses (HIV) [CT284]
Viral Infectious disease IVDs [CT355]
Infectious disease IVDs [CT701]
Session 3B – Medical Devices (IVDs) - Application process 26
GMDN – more examples
IVD medical device GMDN
Multiple urine analyte IVD, kit, colourimetric dipstick, rapid
[30225]
Urine screening IVDs [CT1246]
Clinical chemistry biological screening IVDs [CT1236]
Clinical chemistry IVDs [CT287]
Session 3B – Medical Devices (IVDs) - Application process 27
GMDN – one more example IVD medical device GMDN
Glucose monitoring system IVD, home use/point-of-care
[30854]
No relevant level 3 Collective Term (CT) Clinical chemistry substrate IVDs [CT833]
Clinical chemistry IVDs [CT287]
Session 3B – Medical Devices (IVDs) - Application process 28
IVD Name and Category
For any type of IVD device referred to in Regulation 5.3(1)(j), the application form requires applicants to enter the names of all individual devices of the kind as these
devices appear on the labelling. Session 3B – Medical Devices (IVDs) - Application process 29
Procedure Packs containing IVD • Goods in the package are a system or procedure pack if
- the goods are for use as a unit, either in combination or in a medical or surgical procedure and
- the package contains at least one medical device
• Classification - is determined by the highest class of device included in
the pack or - if all devices are of the same class, it is classified
according to the primary intended purpose of the system or procedure pack
Session 3B – Medical Devices (IVDs) - Application process 30
Procedure packs Reg. 3.3 (9) – highest classification
IVD (Class 3)
MD (Class IIa)
Class 3 IVD
Procedure Pack
Session 3B – Medical Devices (IVDs) - Application process 31
Procedure packs Reg. 3.3 (10) same class
IVD (Class 1)
MD (Class I)
Class 1 IVD or Class I
MD Procedure
Pack
Intended purpose
Session 3B – Medical Devices (IVDs) - Application process 32
One kind of device Supplied as a SINGLE
unit
Instrument
Control/Calibrators Assay Kit
Session 3B – Medical Devices (IVDs) - Application process 33
Devices are not of the same kind
System
Instrument (Class 1 IVD)
Controls / Calibrators
Assay Kit
Accessories
Session 3B – Medical Devices (IVDs) - Application process 34
Where do we go from here?
Ensure all information provided in the
application is correct
Any application may be selected for audit
Some applications must be selected for audit
Session 3B – Medical Devices (IVDs) - Application process 35
Further information
• IVD medical devices regulation basics • News, consultations, guidance, subscribe to updates
TGA website
• Therapeutic Goods Act 1989, Chapter 4 • Therapeutic Goods (Medical Devices) Regulations 2002
ComLaw: Database of Commonwealth law
• [email protected] 1800 141 144
Contact the TGA Medical Devices Branch
36
The Application Process
• Introduction
• This presentation will step through the process of making an application for inclusion on the ARTG
• The format is screen shots highlighting the key steps • Two scenarios will be presented
• An uncomplicated Class2 IVD • A Class 3 IVD requiring higher level scrutiny
The Application Process
• Before you start
• The appropriate Manufacturer’s Evidence for your IVD must be submitted and accepted.
• Know the Class of your IVD. • Know the GMDN term for your IVD.
• Have at hand any other evidence that will be required, such as
• Declaration of Conformity (for all Class 3) • Design Examination Certificate (for all Class 4)
https://business.tga.gov.au
Your company name and number
Navigation buttons top and bottom on each page
Free text
The Application Process
Scenario 1 • Class 2 • Manufacturer Evidence CMDCAS ISO 13485 Certificate • “No” to device product characteristics questions
The Application Process
Scenario 2 • Class 3 • Manufacturer Evidence TGA Conformity Assessment Certificate • “Yes” to device product characteristics questions
• Testing for a sexually transmitted agent
TGA Conformity Assessment Certificate = the application is unlikely to be selected for audit
The Application Process
GMDN selection • The same for either scenario
The Application Process
Finalisation Class 2 • Make the declaration, Validate
and submit
The Application Process
Finalisation Class 3 • Declaration of Conformity to be
attached
Questions?
65
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