Devices Sponsor Information Day: Session 3B: Medical devices (IVDs) - application process
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Devices Sponsor Information Day: Session 3B: Medical devices (IVDs) - application process
- 2. 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
- 3. Medical Devices (IVDs) Applications for ARTG inclusion Euan Miller Application and Verification Section Medical Devices Branch Devices Sponsor Information Day 15 October 2015
- 4. 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
- 5. 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
- 6. 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
- 7. Examples Session 3B – Medical Devices (IVDs) - Application process 6
- 8. 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) Session 3B – Medical Devices (IVDs) - Application process 7
- 9. 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
- 10. Before you start • TGA Business Services (TBS) - Register and get your Client ID Session 3B – Medical Devices (IVDs) - Application process 9
- 11. 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
- 12. Process for ARTG inclusion Session 3B – Medical Devices (IVDs) - Application process 11
- 13. 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
- 14. 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
- 15. 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
- 16. 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 41FD15
- 17. Common questions Kind of device Intended purpose Classification Conformity assessment procedure GMDN code Session 3B – Medical Devices (IVDs) - Application process 16
- 18. Kind of device • Sponsor • Manufacturer • Device nomenclature system code (GMDN) • Classification • Unique product identifier (for Class 4 IVDs) a medical device is taken to be of the same kind as another medical device if they have the same: 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
- 19. 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 Session 3B – Medical Devices (IVDs) - Application process 18
- 20. 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) Session 3B – Medical Devices (IVDs) - Application process 19
- 21. 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 Session 3B – Medical Devices (IVDs) - Application process 20
- 22. 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
- 23. 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 22Session 3B – Medical Devices (IVDs) - Application process
- 24. 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
- 25. 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
- 26. 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
- 27. 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
- 28. 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
- 29. 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
- 30. 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
- 31. 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
- 32. 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
- 33. 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
- 34. One kind of device Supplied as a SINGLE unit Instrument Control/CalibratorsAssay Kit Session 3B – Medical Devices (IVDs) - Application process 33
- 35. 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
- 36. 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
- 37. 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 • devices@tga.gov.au 1800 141 144 Contact the TGA Medical Devices Branch 36
- 39. 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
- 40. 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)
- 41. https://business.tga.gov.au Your company name and number
- 44. Navigation buttons top and bottom on each page
- 46. Free text
- 49. The Application Process Scenario 1 • Class 2 • Manufacturer Evidence CMDCAS ISO 13485 Certificate • “No” to device product characteristics questions
- 52. 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
- 54. TGA Conformity Assessment Certificate = the application is unlikely to be selected for audit
- 55. The Application Process GMDN selection • The same for either scenario
- 58. The Application Process Finalisation Class 2 • Make the declaration, Validate and submit
- 60. The Application Process Finalisation Class 3 • Declaration of Conformity to be attached
- 66. Questions? 65
- 67. Brought to you by:
Notas del editor
- 2015/005470 (R15/689559)
- medical device intended purpose correctly classified essential principles and availability of information to substantiate compliance application of conformity assessment procedure and availability of information to substantiate application requirements (if any) relating to advertising prohibited imports excluded purposes information in or with the application is complete and correct
- Kind of device Intended purpose Classification Conformity assessment procedure GMDN code
- a medical device is taken to be of the same kind as another medical device if they have the same: sponsor; and manufacturer device nomenclature system code (GMDN); and For Class 4IVD – unique product identifier Section 41BE of the Therapeutic Goods Act 1989 and Regulations 1.6 and 1.7 Therapeutic Goods (Medical Devices) Regulations 2002
- Rule 1.3 (2) NNDSS Rule 1.3 (1)(g) human genetic testing Rule 1.3 (1)(f) selective therapy and management for disease staging in the diagnosis of cancer Note for paragraph (f): An IVD medical device would fall into Class 2 IVD under Clause 1.7 if a therapy decision would usually be made only after further investigation; or the device is used for monitoring
- (Clauses 1.8, 4.7, 6.6 and 7.5)
- Ensure all information provided in the application is correct Any application may be selected for audit Some applications must be selected for audit Next presentation will explain the process and requirements for the audit assessments
- Before you start an application You have an ebs account and have received your login details You know the Class of your IVD You have submitted manufacturer evidence appropriate for the Class of IVD you are applying for. If Class 4, you have a Design Certificate If Class 3, you have an Australian Declaration of Conformity You know the GMDN code Enter your login details and login
- At the welcome page Drop down the applications menu
- Select Device/OTG application under medical devices (no mention of IVDs just yet)
- Buttons at the top and bottom of each page Previous, Next – change page Close – closes the draft - save your draft first Save – saves the draft View entire app(lication) – a printable view of the complete application. Print before submitting of you need a copy. A printable version won’t be available after submission. You can also delete and go back to edit from here Validate – to check the application is complete before submission
- Page 1 Device Applications Page Your address and account details are pre filled. Drop down the Application for: list Select Medical Device – IVD from the drop down menu. (or Medical Device – IVD (export only) if you intend to export and not supply in Australia) “Create a new register” is pre selected. Select it if it’s not. The form will reset depending on the options chosen. Specific details irrelevant to IVDs will disappear.
- The form re-sets depending on your “Application for:” selection The irrelevant questions have disappeared Add a reference for your own use, to help you identify your application. Enter, and the Application Class Details and selection field will appear Select your Class from the drop down list Select your Class from the drop down list.
- After selecting Class, more of page 1 appears. The price Questions relating to the Health Technology Assessment Process. (Click on Yes or No as appropriate.) Device Product Characteristics Bottom section. (click Yes or No as appropriate) It varies a little depending on the Class selected. This will be a simple Class 2 application. I will show a more complex Class 3 also.
- Manufacturers intended purpose Should align with the GMDN term Should align with the IFU Should be determined by the manufacturer When list a collective term consider keeping this non-specific. For example, if the IVD is for detecting, IgM, you might want to say ‘antibodies’, so you won’t need a separate entry for the IgG partner product. Use the Help buttons. (they are actually quiet helpful)
- Scroll down to the next section – Device Product Characteristics Answer the Yes/No questions by checking the buttons. Using the Next buttons top or bottom left, go to page 2
- Click Yes and these check boxes appear Enter the name of the IVD, Check the appropriate box and ADD Testing for sexually transmitted agent = the application will be selected for audit
- An ISO 13485, would result in selection for audit, for a sexually transmitted agent In this case, the manufacturer has TGA CA – so the application wont be selected for mandatory audit. Still needs DoC because its Class 3. DoC is added on the final page.
- Adding the GMDN is the same procedure for either of these applications. To open the GMDN Search box, click on Search Type in a keyword, or the code if you know it. Only the GMDN codes for the correct Class are available. If you try to search, say, HIV, no codes will be shown because HIV is Class 4. Select your code. Click OK (If you can’t see the OK and Cancel, drag the box bigger)
- Next takes you to the final page
- Final page Summary of all entered so far Add attachments – Declarations of Conformity, Design Certificate etc The Declaration – read and click Yes Finally – Validate to check all is complete
- To add your DoC or other document, Click ADD to open the download box Select from the drop down list and choose the file from your computer and ADD
- Nearly there! DoC is attached Declaration is made Now Validate
- Print opens the print dialogue box– save as .pdf, print etc Edit re-opens the application for access to all pages using previous/next Close – the application view Delete the application If you want to have a printed record of your application print it now. It will not be available after submission.