Smartdentist and TGA regulations for dental practice

Smartdentist has :

Background

In Dec 2020 the TGA (Theraputic Goods Administration) changes certain aspect of the regulations governing the manufacture and supply of medical devices. Check out this link: Personalised medical devices (including 3D-printed devices)
TGA legislation is quite complex and dental practitioners and dental labs should understand the legislation and regulations BEFORE they notify the TGA that they are making medical devices as it is not the TGA's responsiblity to work out if an application to the TGA is incorrect.
Multiple presentations by the TGA on this topic appear with a disclaimer : "This presentation paper is provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The paper is not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation paper should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper." Beware!

Smartdentist Resources

Smartdentist has training and resources for practices, including policies, with regard to TGA requirements.

Helpful hints in working out if the new TGA regulations affect your dental practice : Before telling the TGA

The TGA registration form does not have enough detail for the TGA to tell you that you are not the manufacturer and should not have registered.

1. Read the description of "what is a medical device".

The term ‘medical device’ is defined by Section 41BD of the Therapeutic Goods Act 1989 as:

Medical devices include crowns, fillings, splints etc.
Mouthguards are not considered medical devices as they are considered personal protect equipement if they are not used for a theraputic purpose. You may also consider a passive dental retainer may not fit the legal description of a medical device. It is the intent of the use by the manufacturer that determines if it is a medical device.

2. Determine whether you would be considered the "manufacturer" of the devices you use.

Under 41BG of the Act "a person is not the manufacturer of a medical device if the person assembles or adapts the device for an individual patient; the device has already been supplied by another person; and, the assembly or adaptation does not change the purpose intended for the device."

E.g. a dental filling is a medical device as is a series of brackets and wires for orthodontic treatment.
However dentists are not considered the manufacturer of these medical devices if they use composite resin that is that is listed on the ARTG (Australian Register of Theraputic Goods) (new window). Another example would be the use of Protemp for temporary crowns. This is listed on the ARTG. If you mill crowns from ceramic blocks that are ARTG included e.g. Cerac Zirconium - then you are not the manufacturer.
(MDPS - if you have heard that you may get an exception from requirements because you use a Medical Device Production System, you need to understand that this system will not be in place for 18 months to 24 months so you still need to register as a manufacturer if you are using raw material that is not ARTG listed but you may find the product you are using is ATRG listed even when you use a 3D printer).
Further TGA information from a 2016 presentation.

2a. Make a list of the medical devices where you might be considered the manufacturer.
Get staff to contact the suppliers of the products you use to make the devices and see if they are ARTG listed. For example an orthodontist uses wires, braces and cement to make a "medical device" to move teeth but because all those things are ARTG listed the orthodontist doesn't need to record themselves as making medical devices when placing braces (as far as I can tell).
If you are not using a ARTG listed material you can change to a listed material and avoid being a manufacturer.

3. Fill out the TGA form to notify that you have made a custom-made device.

This must be done within 2 months of make and supply and the last device you can make under the old rules is on 24 Feb 2020. So if you make and supply all your devices on this day you have until 24 Aug 2020 (changed date ) to complete the next process.
* the ADA issued an email saying the TGA was to make 24 August the date. (previously 25 Feb + 2 months)
For each "kind" of medical device that you consider you are the manufacturer you need to submit the following form. https://forms.business.gov.au/smartforms/servlet/SmartForm.html?formCode=custom-made-medical-

Devices are taken to be of the same kind if they have the following characteristics; the same Manufacturer (that is your practice), the same Classification; the same Global Medical Device Nomenclature System Code (GMDN code).
You can do this per practice. If you go onto the next process in 2024 of being properly TGA registered then you will save fees by having everyone on the same listing.

This table might provide you with the additional information that you will need to fill out the form.
If your item is not listed and you need a GMDN code please let me know as I have access to the GMDN code website.

  Description GMDN Classification
Custom-made mouthguard
**
A custom-made oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is custom-made for a specified patient from impressions of the dental arch. Some types are referred to as nightguards or bite raising appliances. This is a reusable device

**This should ONLY be included as a medical device if you use the mouthguard for a theraputic use such as grinding/clenching. Mouthguards are PPE and NOT medical devices when used for sport.

38620 Class 1
Dental occlusal splint, custom-made
*Check if ARTG listed already
A rigid or flexible custom-made device intended to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, to treat teeth clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporomandibular joint (TMJ) pain (e.g., from TMJ dysfunction). It is typically made of synthetic polymer materials and manufactured to meet the needs of an individual patient. This is a reusable device. 43025 Class 1
Dental crown/bridge, temporary
** Do not include this as a medical device if you use ARTG included products such as protemp
A prosthetic dental device used to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].
(this I imagine would be an essex splint and not a temporary crown/bridge made from specific ARTG listed temporary crown material)
31783 Class 1

Orthodontic retainer

*

An orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.

* I dont believe a non-active retainer is a medical device per the TGA definition so I would not include these. They are not designed to alter anatomy or treat disease. Being class 2 or having crowding is not a disease.

35310 Class 1
Custom-made dental crown, ceramic
**
A device made totally of ceramic material, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.
**if you are milling with cerac these materials are already ARTG listed blocks for the purpose so you shouldnt be the manufacturer
38594 Class IIa
More likely for a dental lab to be doing these
Custom-made dental crown, metal A device made totally of metal alloy material, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth. 38591 Class IIa
Custom-made dental crown, metal/ceramic A device made of a combination of metal and tooth-coloured ceramic, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth. 38593 Class IIa
Dental bridge, ceramic
** Do not include if you mill crowns from ARTG ceramic crown blocks
A custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of ceramic/porcelain material and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture. 38615 Class IIa
Dental bridge, metal-ceramic A custom-made, non-removable, artificial replacement for one or more missing teeth made of metal alloy combined with tooth-coloured ceramic material (veneer), and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture. 38614 Class IIa
Dental veneer, professional
** this does not mean composite veneers
A custom-made dental restoration made of ceramic or polymer-based material (resin) intended to be used in aesthetic dentistry to correct the facial surface of a tooth; it is intended to be applied to the teeth by a dental professional for long-term use, typically via an adhesive. This is a single-use device. 38645 Class IIa
More likely your dental lab is making these. You can do repairs without worrying as you are not considered the manufacturer.
Complete upper denture A custom-made artificial replacement for all teeth in the upper jaw (maxilla) carried on a removable plate or frame which is supported by surrounding soft and hard tissues of the oral cavity. It can be made of a variety of materials including polymers [polymethylmethacrylate (PMMA), polycarbonate (PC)], acrylic, ceramics, and/or metals [e.g., base metal alloys or titanium (Ti)]. 38588 Class 1
Complete lower denture A custom-made artificial replacement for all teeth in the lower jaw (mandible) carried on a removable plate or frame which is supported by surrounding soft and hard tissues of the oral cavity. It can be made of a variety of materials including polymers [polymethylmethacrylate (PMMA), polycarbonate (PC)], acrylic, ceramics, and/or metals [e.g., base metal alloys or titanium (Ti)]. 38589 Class 1
Partial denture A custom-made, removeable, artificial replacement for one or more, but not all, teeth in the lower or upper jaw (mandible or maxilla) in a partially edentulous patient. It typically includes clasps of metal or plastic that clip onto remaining teeth for retention and stabilization. It can be made of a variety of materials including polymers [polymethylmethacrylate (PMMA), polycarbonate (PC)], acrylic, ceramics, and/or metals [e.g., base metal alloys or titanium (Ti)]. Also known as a removable partial denture (RPD). 17845 Class 1
Overdenture A custom-made, removable, artificial replacement for some or all teeth in the lower or upper jaw (mandible or maxilla) that is retained in the mouth with precision dental attachments. The attachments can be placed in retained tooth roots or dental implants. 38590 Class 1
Dental implantation drilling template guide-sleeve A small tubular device intended to be inserted within the guide holes of a dental implantation drilling template (a device used to guide drilling in the jawbone during dental implant placement/fixation) to guide the implant into position. This is a single-use device. 64371 Class 1
Mandible-repositioning sleep-disordered breathing orthosis A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device. 47526 Class 1
Orthodontic progressive aligner
** these tend to already ARTG listed unless you are doing your own thing!
A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Also described as sequential or successive, the device is custom-made based on an oral impression, self-removable, and is typically made of clear/transparent synthetic polymers (e.g., a thermoformed polycarbonate); a post-treatment orthodontic retainer/positioner may be included with the device. This is a reusable device. 44738 Class 1

 

4. Additional requirements to your practice from the 25 Feb 2021 if you have registered as making custom-made medical devices. * this only applies if you have registered.

  1. information to be supplied with the device
    You need to supply a written statement with each device you make. As you need to keep this statement for 5 years for a class 1 item and 15 years for a Class iia (crown) I suggest you add it into your patient record area (but you can pick another system). Manufacturers may choose to supply the statement digitally, provided sufficient information is provided with both the statement and the device to allow the user (that is you 'supply' it to a patient) to correctly match the two. ;
  2. record keeping requirements
    1. Good patient notes justifying the use and requirements of the device!
    2. Keep statements 5 or 15 year (as above)
    3. your annual reports to the TGA (the first one will be due in Oct 2021)
    4. evidence documentation. Manufacturers and sponsors of custom-made medical devices must hold evidence demonstrating the devices they manufacture comply with all relevant Essential Principles as described in Schedule 1 of the Regulations. The Essential Principles checklist may assist manufacturers and sponsors with establishing documentation demonstrating compliance. You keep records for each device that you manufacture, including the original health professional’s request for manufacture, a copy of the statement he supplied with the device and any other information he feels is pertinent (including any design or materials documentation that are unique to each device). This can be the one form when you make the device for yourself;
    5. Adverse events
      You need to have a system of recording adverse events if you are a manufacturer and you need to report them to the TGA if they are defined as serious. Serious seems to include: "a condition necessitating medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure." https://www.tga.gov.au/adverse-event-reporting
      You can use your Smartdentist incident reporting system as a demonstration of your quality control system.

  3. annual reporting
    1. If you have both external supplied (e.g. made by an dental lab) and you also sometimes make the same item e.g. splints or retainers then you need to change your item code recording because you will want an easy way to annually report numbers to the TGA. The TGA said this annual report will be easy to complete. Dont report devices that someone else has made!;
  4. inspection and review
    If you are the manufacturer or the sponsor of a custom-made medical device, you must have the following available at all times:
    • sufficient information to substantiate the conformity assessment procedures prescribed under Part 7.2 of Schedule 3 of the Regulations have been applied to the device; and
    • information relating to the design and manufacture of the device and any changes made to the device.
    This information must be supplied to the TGA on request. Manufacturers and sponsors also have obligations under the regulatory amendments relevant to inspection; as outlined here
    1. An authorised person (a delegated TGA officer) may request documentation of any kind relating to the custom-made medical device including, but not limited to:
      • a copy of the original health professional’s request for the device;
      – in cases where the health professional is the manufacturer, this could be a document outlining the clinical notes taken to inform design of the device.
      • any information supplied with the device ; and
      • evidence of conformity assessment documentation.

5. New decision by 25 August 2021.

If you are manufacturing or supplying custom-made medical devices which are considered patient-matched appliances, transitional arrangements are in place to ensure you can continue to supply your device while you apply for it to be included in the ARTG. To access these arrangements you must submit this form before 25 August 2021.

The form to submit notification is located here : https://consultations.health.gov.au/tga/accessing-transition-arrangements-patient-matched/

Once you have submitted this form, you will have until 1 November 2024 to submit an application for inclusion in the ARTG. More information about the inclusion process can be found on TGA website: https://www.tga.gov.au/publication/medical-device-inclusion-process

Compliance issues:
Class 1 devices will be relatively easier to move to patient-matched devices but Class iia devices such as crowns will require that you undertake ISO 13485 certification. (About 5000 for initial certification and then about 2500 per year per manufacturer - not per item. This is not a TGA cost.
TGA Costs:
Each GMND item has its own application and annual fee for TGA. The fee for Class iia devices is about $1000 per application and $1000 per year. Expect it to rise as the TGA has been losing money.

NOTE: if you consider that your medical devices will remain custom-made then you do not have to complete submit the form on 25 August. The basis of this consideration is:

"the requesting health professional has determined is necessary to address the matters covered by paragraph (b) because there is no kind of medical device included in the Register to address those matters or to address those matters to an appropriate level." e.g. design characteristics are intended to address:
(i) either or both of the anatomical and physiological features of the intended recipient; or
(ii) a pathological condition of the intended recipient;