Presentation: Custom-made medical devices: Information for the dental industry
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Custom-made medical devices. Information for the dental industry on the legislative framework and regulatory obligations pre and post market.
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Presentation: Custom-made medical devices: Information for the dental industry
- 1. Custom-made medical devices Information for the dental industry Valerie Mercer Director Medical Devices Information and Education Medical Devices Branch Therapeutic Goods Administration ADIA industry briefing 12-13 July 2016
- 2. Discussion topics • Legislative framework • What is custom-made? • Notifying TGA • Regulatory obligations - pre-market - post-market ADIA industry briefing 12-13 July 2016 1
- 3. Regulatory framework Commonwealth legislation • Therapeutic Goods Act 1989 especially Chapter 4 Medical Devices • Therapeutic Goods (Medical Devices) Regulations 2002 • https://www.tga.gov.au/legislation-legislative-instruments ADIA industry briefing 12-13 July 2016 2
- 6. Definitions Medical device • s41BD of the Act defines a medical device as … ADIA industry briefing 12-13 July 2016 5
- 7. Definitions Custom-made medical device • the Regulations define a custom-made medical device as …. • examples relevant to the dental industry may include: - crowns - bridges - dentures - specialised instruments ADIA industry briefing 12-13 July 2016 6
- 8. ‘Customised’ does not equal a custom-made medical device • an existing medical device that is adapted, altered, fashioned, modified or ‘customised’ to fit a patient is NOT a custom-made medical device • for example, a preformed permanent dental crown that may require minimal fashioning in situ during restorative work is not a custom-made medical device • devices already included on the ARTG that are combined and adapted for an individual (provided the devices are used as intended by the manufacturer/IFUs) are not custom-made medical devices (orthodontic braces) ADIA industry briefing 12-13 July 2016 7
- 9. Definitions Manufacturer • s41BG of the Act defines a manufacturer as … ADIA industry briefing 12-13 July 2016 8
- 10. Definitions Sponsor • s3 of the Act defines a sponsor as … • sometimes the sponsor and the manufacturer are the same entity e.g. a dental laboratory that supplies their products directly to dental professionals • dentists and allied oral healthcare providers can import custom-made devices from overseas, but in doing so they become the sponsor and acquire obligations 9
- 11. Definitions Kinds of devices • s41BE of the Act defines kinds of medical devices as … • TGA needs to be notified of each kind of device • TGA does not need to be notified about each individual device being made for individual patients ADIA industry briefing 12-13 July 2016 10
- 12. Kinds of medical devices - examples Example 1 Dentist (sponsor) imports polymer dental bridges manufactured by Manufacturer A in China: - same sponsor - same manufacturer - same GMDN code - same classification Therefore same kind of medical device and only one notification to TGA required. Do not need to notify TGA for each patient receiving a custom-made medical device of this kind. Example 2 Dentist (sponsor) imports polymer dental bridges manufactured by Manufacturer A in China and Manufacturer B in Germany: - same sponsor - different manufacturers - same GMDN code - same classification Therefore not the same kind of medical device and separate notifications required for each kind. Again, do not need to notify TGA for each patient, only the kind of device. ADIA industry briefing 12-13 July 2016 11
- 13. Regulatory obligations Who has obligations? • both the manufacturer and the sponsor have obligations • requirements to: - meet the essential principles (EPs) - this demonstrates the quality, safety and performance of the device - apply a conformity assessment procedure - this generates evidence that the device complies with the EPs - notify the TGA - comply with advertising requirements - report adverse events But aren’t custom-made devices ‘exempt’? • exempt from ARTG inclusion only • all other obligations still apply ADIA industry briefing 12-13 July 2016 12
- 14. Requirement to notify TGA • since 2002, Australian manufacturers and sponsors importing custom-made medical devices into Australia have been required to notify TGA about certain details, e.g. name and business address, description of the ‘kind of device’ • in February 2016 the regulations were amended to introduce a two month timeframe for notification to the TGA • details in Regulation 10.3 ADIA industry briefing 12-13 July 2016 13
- 15. How to notify … • simple web-based notification form • quick and easy to complete and submit • some fields mandatory • within 2 months of the device being manufactured in Australia or first imported into Australia www.tga.gov.au/custom-made-medical-devices ADIA industry briefing 12-13 July 2016 14
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- 22. Other regulatory obligations Essential Principles • Regulations Schedule 1, Part 1 (general principles) and Part 2 (principles about design and construction) • manufacturer must meet the applicable essential principles • sponsor must ensure device meets applicable essential principles • some EPs may not apply to the device (e.g. if the custom-made medical device is not supplied in a sterile state, the essential principles regarding sterility are not relevant and will not need to be met) • some essential principles apply only to custom-made medical devices: - information that must be provided with a medical device - an indication that the device has been custom- made for a particular individual or health professional and is intended for use only by that individual or health professional must be provided with a custom-made medical device - instructions for use (if required) must include an indication that the device has been custom-made for a particular individual or health professional and is intended for use only by that individual or health professional • there is an ‘essential principles checklist’ on TGA’s website which may be helpful (not mandatory) ADIA industry briefing 12-13 July 2016 21
- 23. Other regulatory obligations Conformity assessment procedures The manufacturer is required to: • prepare and sign a written statement containing specific information (detailed in the Regs sched 3 item 7.2) • prepare documentation relating to the design, production and intended performance of the device (and keep the documentation up-to-date) • take all measures necessary to ensure that the manufacturing process results in the device complying with the documentation mentioned above • notify the TGA as soon as practicable of certain events that might lead (or might have led) to the death or serious deterioration of the state of health of the patient or user, or caused the manufacturer to recover a device that has been distributed. Examples of these events include malfunction, deterioration and inadequacy in the design, production, labelling or instructions for use. The sponsor is required to ensure that the manufacturer has applied the conformity assessment procedures. ADIA industry briefing 12-13 July 2016 22
- 24. About the ‘statement’ Details to be included: • name and business address of manufacturer • information to identify the device • statement that manufacturer intends device to be used only for a particular individual or health professional • name of the individual or health professional • name and business address of health professional that provided device specifications • particular design characteristics or construction provided by health professional • a statement that the device complies with the applicable essential principles, or a statement explaining which essential principles it does not comply with and reasons for the non-compliance Statement to be signed and dated by an authorised person (from the manufacturer) and kept up-to-date ADIA industry briefing 12-13 July 2016 23
- 25. Therapeutic Goods Advertising Code 2015 General Principles Section 4 sets out the key requirements including that therapeutic good advertisements “must not”: • Mislead or be likely to mislead • Arouse unrealistic expectations of product effectiveness • Lead consumers to self-diagnosing, inappropriately treating or believing they have a serious disease • Abuse consumers’ trust or exploit their lack of knowledge • Encourage inappropriate or excessive use • Claim that a good is guaranteed, certain, sure cure or that the goods are completely safe or harmless • Be directed to minors (subject to exceptions) https://www.legislation.gov.au/Details/F2015L01787 ADIA industry briefing 12-13 July 2016 24
- 26. Adverse events What to report 25ADIA industry briefing 12-13 July 2016
- 27. Summary • Both manufacturers and sponsors/suppliers of custom-made medical devices have obligations • ‘Custom-made’ has a specific meaning and is defined in the regulatory framework (not customised/adapted) • Custom-made devices have specific requirements for information to be supplied with the device • Custom-made devices are exempt from ARTG inclusion, but other obligations still apply • Timeframe for notifying TGA of custom-made devices is 2 months - from initial manufacture (if manufactured in Australia) - from initial importation/supply in Australia (if manufactured overseas) • Notifying TGA is only one obligation – others include: - device must meet essential principles - device must have had conformity assessment procedure applied - adverse events must be reported to TGA ADIA industry briefing 12-13 July 2016 26
Editor's Notes
- If a dental technician or prosthetist: uses devices (raw materials) included on the ARTG in accordance with their intended purpose, then the technician/prosthetist is adapting devices for an individual and is neither a manufacturer or sponsor uses devices (raw materials) included on the ARTG but not in accordance with their intended purpose, then they are manufacturing custom-made devices uses raw materials not included on the ARTG, they are manufacturing custom-made medical devices Examples: an orthodontist uses a number of devices included on the ARTG (e.g. orthodontic metal bands, orthodontic springs, orthodontic archwire, etc) for the purpose intended by the manufacturer (i.e. to make braces for a specific individual) the orthodontist is adapting these devices for a specific individual (i.e. not a manufacturer) a dental technician using a polymer-based dental material to make a denture base as detailed in the product’s IFU is adapting the material for a specific individual (not a manufacturer) a dental prosthetist that uses an ARTG included dental crown resin (a composite material intended to be used for veneering metallic dental crowns) to make a hard denture base (i.e. not in accordance with the IFUs) is a making a custom-made device and meets the definition of a manufacturer. Note: GMDN 61718 – Preformed dental crown, permanent A prefabricated prosthetic device designed to function as a permanent artificial covering to partially or fully replace the damaged crown of a tooth. It is made of ceramic and polymer materials and may require minimal fashioning in situ during restorative work. It is available as a single prosthesis or multiple prostheses of various shapes and sizes, and may include one or more try-in prosthesis replicas and other devices intended to assist the restoration procedure (e.g. disposable prosthesis gauge).
- Examples: A legal entitiy in China that designs, produces, packages, labels with their own name and exports (including to Australia) pre-formed permanent crowns is a manufacturer. An individual based in Canberra imports large numbers of dental implant template retention pins that are manufactured in Germany, but packages the dental pins into smaller units, labels the packaging with their own names and supplies/sells the dental pins to other dental laboratories in Australia (or overseas) is a manufacturer and sponsor. A dental laboratory based in Melbourne that: imports (from overseas) non ARTG included polymer material, dental implant template retention pins and other items necessary for their dental technicians to produce dental crowns (in accordance with specifications provided by a dentist) – is a manufacturer of custom-made devices and also packages, labels and sells the crowns to other dental laboratories –is a manufacturer and sponsor.
- In order to be legally supplied in Australia, most medical devices must be included in the ARTG. This is where custom-made medical devices differ. Custom-made medical devices do not need to be included in the ARTG but they must still meet the other requirements, i.e. quality, safety and performance. Several means by which ‘unauthorised medical devices’ (i.e. those not included in the ARTG) can be legally supplied in Australia: custom-made medical devices clinical trials scheme authorised prescriber scheme special access scheme Custom-made medical devices do not need to be included in the ARTG but must comply with all other obligations.
- In this instance, like many others, the functions of the Secretary of the Department of Health have been delegated to officers within the TGA. Therefore ‘give the following information to the Secretary’ means give the info to the TGA. The Regulations were amended in early 2016 following requests from the dental industry bodies: - in recognition that the majority of people in the industry want to comply with the regulatory obligations - to clarify the timeframe of the obligation to notify - in addition, TGA provided a simple means of notification, i.e. the web-based notification/reporting form
- If the custom-made device is manufactured in Australia, the Australian manufacturer must notify the TGA If the custom-made device is imported into Australia by a dentist, dental laboratory, etc but is manufactured overseas, the sponsor must notify the TGA (i.e. whoever imports and supplies the device in Australia – and this includes supplying/implanting/affixing it to a patient)
- Select manufacturer or sponsor. In some circumstances this is the same entity. TGA is planning to amend the form so that this option is available. The first example demonstrates how a manufacturer will complete the form, i.e. an Australian manufacturer (manufacturers located overseas are not required to notify TGA – in this instance the obligation to notify is transferred to the Australian sponsor who imports and supplies).
- The mandatory fields are simple details: Manufacturer’s name and business address Sponsor’s name and address Brief description of the device Classification of the device Note that GMDN code is not a mandatory field. Codes are available through GMDN Agency membership (cost involved) or through TGA Business Services (must have client id and mock up an ARTG application). Other non-mandatory details include contact info (email and phone) which TGA may need to use in case of post-market activities or recalls .
- This is the page you will see once you have successfully completed a notification. You can immediately download a copy of the completed form or have a copy emailed to any address you enter here (may or may not be the same email address you gave when you completed the form – either way you will need to enter the email address here).
- If you nominate to have an emailed version sent to you, this is the email you will receive. Note that the completed form is an attachment ….
- This is the view you will see once you open the attachment. Again you can save a copy of this if you choose.
- The form has some additional fields for completion if you are a sponsor. You will need to include the manufacturer’s details (often an overseas manufacturer, but may be an Australian manufacturer) as well as your own details as the sponsor. Just like we saw when an Australian manufacturer completes the notification, the sponsor receives the same option to download a copy of the completed form or receive it as an attachment to an email. Question: does an Australian manufacturer of custom-made medical devices need to notify if they only export? Answer: Not explicitly required but the intention of the legislation appears to be for application to custom-made devices that will be supplied in Australia. However, this could be interpreted to apply to export-only also.
- Notifying TGA about the manufacture or importation of custom-made medical devices is one of several obligations which the Australian manufacturer and sponsor are required to meet/satisfy. Essential principles – demonstrate the quality, safety and performance of the device – this is especially important if the device is manufactured overseas (if manufactured in Australia the manufacturer will also be notifying TGA and meeting the essential principles) Conformity assessment procedure – a procedure that generates the evidence that the device complies with the essential principles Prepare and keep up to date a statement about the device Comply with advertising requirements Report adverse events Chapter 4 of the Act details penalties for importing, supplying or exporting a medical device that does not comply with the essential principles: - s41MA lists criminal offences – 12 months prison or fine or both - s41MAA lists civil offences – fines for individuals and bodies corporate Importing and supplying and exporting A person commits an offence if the person imports/supplies/exports a device and: - use of the device has resulted in harm or injury to any person - use of the device will result in harm or injury to any person - use of the device would be likely to result in harm or injury to any person - the harm or injury is because the devices does not comply with the essential principles (other than labelling) and - the secretary has not consulted to the importation/supply/export and the device is not of a kind covered by an exemption (i.e. national interest such as for stockpiling for emergency preparedness or to deal with an actual threat to public health caused by an emergency) Penalty: imprisonment for 12 months or a fine (or both)
- If the Australian sponsor is supplying a product that was manufactured overseas, then the sponsor/supplier is taking responsibility for the device and making assurances that it is manufactured in accordance with the essential principles (i.e. it is of appropriate quality, is safe and will perform as intended).
- The manufacturer must prepare the statement and keep it up-to-date, but there is no need to provide it to TGA unless requested.
- Object of the Advertising Code To ensure that the marketing and advertising of therapeutic goods to consumers is conducted in a manner that promotes the quality use of therapeutic goods, is socially responsible and does not mislead or deceive the consumer Assessed in terms of probable impact upon a reasonable person to whom the advertisement is directed. Advertising Tips Hold the appropriate level of evidence Claims must be consistent with intended purpose No references to prohibited or unapproved restricted representations, “TGA approved” or to the product being safe Endorsements and testimonials must comply fully with the Code Include mandatory warning statements Advertising Complaints Complaints about medical device advertisements directed to the public that do not comply with the advertising requirements can be made to the: Complaints Resolution Panel – TV, radio, newspapers, magazines, cinemas, posters Medical Technology Association of Australia – in-store material, brochures Therapeutic Goods Administration Complaints considered by the Complaints Resolution Panel may result in the advertiser being requested to take certain actions. The Panel may make a recommendation to the Secretary of the Department of Health (TGA) where the Advertiser fails to respond, or fails to indicate an intention to comply fully with Panel’s requests.
- Again, the Secretary has delegated this function to officers within the TGA. We commonly refer to these occurrences as post-market issues or adverse events. Note that the manufacturer and sponsor have obligations to report adverse events to the TGA and the Regulations provide penalties if this is not done within prescribed timeframes. The Regulations also state the manufacturer must notify the TGA as soon as practicable after becoming aware of: (a) an information relating to: (i) any malfunction or deterioration in the characteristics or performance of the device (ii) any inadequacy in the design, production, labelling or instructions for use of the device (iii) any use in accordance with, or contrary to, the used intended by the manufacturer of the device that might lead, or might have led, to the death of a patient or a user of the device, or to a serious deterioration in his or her state of health (b) information relating to any technical or medical reason for a malfunction or deterioration of the kind mentioned above that has lead the manufacturer to take steps to recover a device that has been distributed