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 understanding of the regulatory requirements for medical devices ARTG inclusion – explain the process and give some examples 2

Overview • Key definitions and regulatory framework • Manufacturer’s Evidence • Information in an application • Avoiding common problems in applications 3

What is a medical device? • Used for human beings • Intended purpose – Diagnosis, prevention, monitoring, treatment or alleviation of disease or compensation for injury or disability – 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 4 Therapeutic Goods Act 1989, section 41BD

What is an IVD? • 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 Therapeutic Goods (Medical Devices) Regulations 2002, Dictionary 5

ARTG inclusion • Any medical device must be included in ARTG • Except: - Exempt devices (e.g. custom-made medical devices) • Sponsor is responsible for ARTG inclusion • Before you start • TGA Business Services (TBS) – Register and get your Client ID 6

Process for ARTG inclusion Basics - process through TGA 7

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 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 8

Manufacturer Evidence  Submitted  Accepted − What does it mean? Go to the next step - lodging application for ARTG inclusion 9

Application for ARTG inclusion • Must be made for a kind of device and • 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

What we look at Kind of device Intended Purpose GMDN Code Device Product Characteristics Classification Conformity Assessment Procedures 11

Kind of device • Sponsor • Manufacturer a medical device is taken to • Device nomenclature system code (GMDN) be of the same kind as another medical device if • Classification they have the same : • Unique product identifier (UPI) (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 12

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 (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) 13

Global Medical Device Nomenclature (GMDN) - One of the characteristics that defines the kind of device - 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) Manufacturer’s responsibility 14

Device Product Characteristics • Ensure ‘Device Product Characteristics’ section in the application is correctly filled in 15

Medical devices are classified having regard to the intended purpose of the device Class I Class Is and Class IIa Class IIb Class III and Class Im AIMD The lowest level The highest level Therapeutic Goods (Medical Devices) Regulations 2002, Part 3 Division 3.1 and Schedules 2 16

IVD medical devices are classified having regard to the intended purpose of the device and its risk to public health and/or personal risk • Class 1 IVD – no public health risk or low personal risk • Class 2 IVD – low public health risk or moderate personal risk 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 17

Conformity assessment procedure • Minimum conformity assessment procedures for different Classes of devices • 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 18

Conformity assessment procedures • Minimum conformity assessment procedures for different Classes of devices Class III device Class Is device supplied sterile (e.g. Sterile surgical gown) (e.g. Knee Femur) Annex II.3 - Full Quality Assurance Annex V – Production Quality Plus Plus Annex II.4 - Examination of Design Declaration of conformity (Part 6, Schedule 3) OR OR Annex III - Type Examination Plus: Annex II.3 - Full Quality Assurance Annex V - Production Quality Assurance 19

One page document • Describe the device and intended purpose if needed in more detail • 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 20

Information provided in the application • Do not attach information that is not relevant with the 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 21

Examples of common mistakes Incorrect Device Incorrect Classification Product Characteristics Attaching documents not relevant, which do not meet requirements Scope of EC certificate GMDN code not most does not correctly cover relevant for the kind of the kind of device device 22

Where do we go from here? 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 23

SME Assist • Guidance on TGA website • Interactive online tool 24

Further information TGA website TGA website • Medical devices (http://www.tga.gov.au/medical-devices-ivds) • SME Assist (https://www.tga.gov.au/sme-assist) Federal Register of Legislation • Therapeutic Goods Act 1989 Chapter 3, Part 4-5 • Therapeutic Goods (Medical Devices) Regulations 2002 Contact the TGA Medical Devices Branch ntact the TGA Medical Devices Branch • devices@tga.gov.au ph.: 1800 141 144 25

Thank you! 26

Juliana William Sr RA Associate Baxter Healthcare 11/10/2017 Devices Sponsor Information Day 28

Agenda Successful and Efficient Submission Preparation  Checks to do  Additional information  Non-mandatory audit submissions  This presentation will not cover details of: • Systems and Procedure Packs • Conformity Assessment • Audit Assessment • Class III/AIMD, UPI and Variants • Clinical Evidence & Risk Assessment compliance 11/10/2017 Devices Sponsor Information Day 29