Medical Devices Manufacturer Evidence and applications for - - PowerPoint PPT Presentation
Medical Devices Manufacturer Evidence and applications for inclusion in the ARTG Susan Barker Devices Application and Verification Section Medical Devices Branch Devices Sponsor Information Day 11 October 2017 Purpose Facilitate better
Manufacturer Evidence and applications for inclusion in the ARTG
Susan Barker Devices Application and Verification Section Medical Devices Branch Devices Sponsor Information Day
11 October 2017
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Intended purpose
Diagnosis, prevention, monitoring, treatment or alleviation of disease or compensation for injury
Investigation, replacement or modification of anatomy or physiological processes Control of conception
Principal intended action
Not by pharmacological, immunological or metabolic means
Definition of IVD in the MD Regulations Products declared to be or not to be a medical device
Therapeutic Goods (Articles that are Medical Devices) Specification and/or Therapeutic Goods (Articles that are not Medical Devices) Orders
Accessory to a medical device as described above
Therapeutic Goods Act 1989, section 41BD
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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
Therapeutic Goods (Medical Devices) Regulations 2002, Dictionary
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Any medical device must be included in ARTG Except:
Sponsor is responsible for ARTG inclusion
TGA Business Services (TBS)
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Basics - process through TGA
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(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 I medical devices (no measuring function and/or not supplied sterile), Class 1 IVD, and/or Export Only TGA conformity assessment certificate EC Certificate issued under MDD 93/42/EEC, AIMDD 90/385/EEC, IVD 98/79/EC MRA certificates issued by EU Notified Body (with certain exceptions) Declarations of conformity made under Clause 7.5 of Schedule 3 (systems or procedure
packs)
ISO 13485 for IVDs only
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Go to the next step - lodging application for ARTG inclusion
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Must be made in accordance with a form and manner approved (via TBS) and Application fee must be paid and For the devices that must have TGA conformity assessment certificate – such certificate is in force and Must not contain information that is false or misleading in a material particular
Therapeutic Goods Act 1989, sections 41FC and 41EA, and Therapeutic Goods (Medical Devices) Regulations 2002, regulation 4.1 10
Kind of device Intended Purpose GMDN Code Device Product Characteristics Classification Conformity Assessment Procedures
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a medical device is taken to be of the same kind as another medical device if
they have the same:
(for Class III and active implantable medical devices (AIMD), and Class 4IVD, except immunohaematology reagent)
Therapeutic Goods Act 1989, section 41BE and Therapeutic Goods (Medical Devices) Regulations 2002, regulations 1.6 and 1.7
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it to be used, as stated in the information provided with the device (labelling, 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 Note: The manufacturer must have evidence that the device performs as intended (refer essential principles)
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Is to be consistent with the intended purpose of the device Must be the code that best describes the kind of device For medical devices (not-IVD) – relevant preferred term (except Class I – relevant template term) For IVDs - collective terms (Level 1, 2 or 3) (except Class 4IVD that is not immunohaematology reagent - relevant preferred term)
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correctly filled in
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Class I The lowest level Class Is and Class Im Class IIa Class IIb Class III and AIMD The highest level Therapeutic Goods (Medical Devices) Regulations 2002, Part 3 Division 3.1 and Schedules 2
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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, Schedules 2A
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Sufficient information to demonstrate application of the appropriate conformity assessment procedures to the kind of device
Part 3 Division 3.2 and Schedule 3, Therapeutic Goods (Medical Devices) Regulations 2002
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devices
Class Is device (e.g. Sterile surgical gown) Class III device supplied sterile (e.g. Knee Femur) Annex II.3 - Full Quality Assurance Annex V – Production Quality Plus Declaration of conformity (Part 6, Schedule 3)
Annex III - Type Examination Plus: Annex V - Production Quality Assurance Annex II.3 - Full Quality Assurance Plus Annex II.4 - Examination of Design
OR OR
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Cite the classification rules in accordance with Schedule 2 or 2A of the Regulations and provide justification where required Explain how the kind of device is covered under the scope of certificate included in Manufacturer’s Evidence Make sure all the information is complete and correct Do not attach more than one page
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application, for example: Declaration of conformity made under EU Medical Device Directive Audit and/or technical data reports Ensure intended purpose is clear and correct Ensure the device is classified correctly Ensure the Manufacturer’s Evidence stated in the application contains correct certificate
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Incorrect Device Product Characteristics GMDN code not most relevant for the kind of device Incorrect Classification Scope of EC certificate does not correctly cover the kind of device Attaching documents not relevant, which do not meet requirements
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Matters certified under s.41FD
Ensure all information provided is correct
Any application may be selected for audit Some applications must be selected for audit
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TGA website
Therapeutic Goods Act 1989 Chapter 3, Part 4-5 Therapeutic Goods (Medical Devices) Regulations 2002 ntact the TGA Medical Devices Branch
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Contact the TGA Medical Devices Branch TGA website
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Juliana William
Sr RA Associate Baxter Healthcare
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Successful and Efficient Submission
Preparation Checks to do Additional information Non-mandatory audit submissions This presentation will not cover details of:
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Manufacturer Evidence (ME)
certificates are provided
Conformity
(missing attachments)
Device Application (DA)
match the ‘Intended purpose’
the EC Certificate scope
Certificate Annex) is not appropriate for the proposed Class
evidence!
Administrative
pages!
find information easily
bookmarking
processed
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Ensure a legal/quality/distribution agreement is/are in place which outline clearly roles and responsibilities for post-market monitoring, vigilance and reporting obligations Obtain Australian Declaration of Conformity from manufacturer
Make sure you have the right template for class and conformity route. See http://www.tga.gov.au/industry/devices-forms-declaration-conformity.htm Ensure the codes listed are the code to be registered and marketed
Obtain Australian Essential Principles Checklist from manufacturer
explain the differences between EU ER and Australia EP.
Product Labelling and Instruction for Use Risk Management Report and Clinical Evaluation Report
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Check whether the device:
Sterile? What is the sterilisation method Measuring function? Invasive? Reusable or Single Use? Active? Single product or System or Procedure pack? Contains a medicine? Contains material or ingredients of microbial/ recombinant / GMO/ animal/ human
Is the device classified correctly according to the TGA Classification
Rules? (Schedule 2 of The Regulations)
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The medical devices regulatory framework has a classification system for medical devices. The detailed legislation is in:
1989 (the Act) Regulation 3.2 of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations) Schedule 2 of the Regulations.
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Is the assigned GMDN code appropriate? (Section 10 of the Regulation)
Remember that manufacturer assign the GMDN code. Check if the GMDN is on the TGA database. If the GMDN code is not in the TGA database, ask for it to be added in advance by email to ebs@tga.gov.au There may be differences between the GMDN Agency code table database and the TGA code table database. Based on the Device information, is the GMDN appropriate and reflects the intended purpose? Must be a preferred term
Does the device perform according to its intended purpose?
This should be a detailed description of the manufacturers intended purpose and should closely align with the relevant GMDN description Remember: Intended purpose is different from Functional description (describes the
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Is the device same kind of medical device (Section 41BE of The Act)? A medical device is of the same ‘kind’ if it has the same:
Intended purpose Classification GMDN code Legal manufacturer Sponsor
Does it have appropriate evidence of Conformity Assessment?
ARGMD Section 5 Conformity Assessment Overview Need to check the appropriate level and route is held by the manufacturer according to the classification
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There are a number of important details that a sponsor should check to ensure that the certificate is valid for particular devices. Refer to Section 7 of the ARGMD
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If there is additional information that could help the assessor, then it would be beneficial to attach a ONE PAGE ONLY document with the application illustrating:
A Picture/diagram of the device A description of the device (not the intended purpose) A description of the mechanism of action (how it works) How the device is included in the scope of the CE Certificate Evidence of the same kind of medical device (for multiple devices)
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Any Device Application is subject to non-mandatory audit. Be prepared to submit any documents from Level 1 or 2 audit list, as well as anything else you may need to show compliance with any of the Essential Principles or Conformity Assessment Procedures. Examples:
Compliance with Essential Principles
Notified Body audit reports to verify the validity of the EC Certificate
Product labelling and IFU
Explanation and justification of Classification
Recent Clinical Evaluation Report
Recent Risk Management File
Compliance with particular standards (or justification why it is not complied with)
Remember you declare you can submit in 20 days!
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Provides all items requested by the TGA Electronic and easy to navigate (entire document): Clear table of content (hyperlinking and bookmarking work!) Text readable Page numbers throughout Up-to-date Clinical Evidence Report (signed by a clinical expert!) Up-to-date Risk Management File
Well prepared submission will: Allow the delegate to easily navigate and find information quickly. Reduce the number of questions raised by the delegate Speed approval The better quality the submission, the easier it is to read and evaluate
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Make sure you understand your product. Do your preparation and verify information before submission! Time spent before submitting is well worth it and will increase your success rate
Engage your cross function team (R&D/Quality/Medical/Clinical..etc) well in advance of your
submission plan. Discuss application requirements and TGA’s expectation.
Submit meaningful, helpful and well-set out information. Perform second check before sending
application and electronic files
Clearly explain the scope of your application in the cover letter
Provide comprehensive Table of Content
Ensure all hyperlinks and bookmarks are actually working
Ensure all documents and attachments are provided with the application! Don’t submit extra documents that aren’t useful or haven’t been requested
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