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TGA presentation: Association for Research in Vision and Ophthalmology Asia Conference, 8 February 2017

10 March 2017

Disclaimer

These presentation papers are 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 papers are 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 papers 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.

Poster: How are ophthalmic medical devices regulated in Australia?

  • Poster by: Mario Vittorino, Devices Clinical Section, Medical Devices Branch, Therapeutic Goods Administration
  • Presented at: Association for Research in Vision and Ophthalmology Asia Conference
  • Presentation date: 8 February 2017
  • Poster summary: The Therapeutic Goods Administration requires manufacturers of high-risk ophthalmic devices to demonstrate safety and effectiveness before the devices can be marketed. This poster presentation describes a study of the TGA's evaluation process of these devices.

How are ophthalmic medical devices regulated in Australia?

How to access a pdf document

Print version of poster: How are ophthalmic medical devices regulated in Australia? (pdf,325kb)

Introduction

The global medical innovation and technology industry brings thousands of market proposals for medical devices every year1, including ophthalmic devices. However, there have been concerns about the safety and performance of high risk devices. Although thousands of drugs obtain approval only after randomised controlled trials, relatively few new medical devices are subject to comparable studies2. The Therapeutic Goods Administration (TGA) is the Australian regulatory body in charge of evaluating these applications.

Australia's regulatory framework

The TGA safeguards and enhances the health of the Australian community through effective and timely regulation of therapeutic goods. A robust legislative basis is in place to support these objectives such as the Therapeutic Goods Act 1989.

Medical devices are classified using a set of rules based on manufacturer's intended use of the device, level of risk to patients, users and other persons (the probability of occurrence of harm and the severity of that harm), degree of invasiveness in the human body and duration of use (Table 1).

Table 1: The TGA medical device classification system
Medical device classification Level of risk Examples
Class I
Includes measuring and sterile
Low to low-medium Bandages, non-sterile dressings, occluders
Class IIa Low-medium X-ray films, intravenous tubing, contact lenses, lubricatingeyedrops
Class IIb Medium-high Dressings for severe wounds, femtosecond laser systems
Class III High Intraocular lenses, glaucoma implants, medical devices that contain medicines
Active implantable medical devices (AIMD) High Retinal implant

Note: In-Vitro Diagnostics (IVDs) are regulated as a subset of medical devices - there are several points of difference between the regulation of IVDs and medical devices including classification

Specific provisions are given for the evaluation of ophthalmic devices. The TGA requires manufacturers of high-risk ophthalmic devices such as intraocular lens implants to demonstrate safety and effectiveness before the devices can be marketed.

The current Medical Device Standards Order3 determines the matters in the relevant standards or parts of those standards published by the International Organization for Standardization, specifically intraocular lenses4. Another example of specific standards used corresponds to Implantable Glaucoma Devices5.

Assessment of ophthalmic device applications

The level of assessment of a particular ophthalmic device depends on the intended use of device and/or risk classification and/or other questions/concerns TGA may have. Clinical evidence has to be provided by the manufacturer to demonstrate that it is designed and produced to be safe, fit for purpose and perform as intended.

5758 applications for medical devices were received by the TGA during the period analysed, most of them were classed as low risk devices6 (Figure 1).

Figure 1: Medical devices applications by classification (July 2015-June 2016)

Medical devices applications by classification (July 2015-June 2016)

Class 1 - 57%

Class 2 - 35%

Class 3 - 7%

Active implanatable medical devices - 1%

From the applications that underwent a review of clinical evidence, less than 3% were related to ophthalmic devices (Figure 2).

Figure 2: Percentage of ophthalmic device applications from total applications reviewed

Percentage of ophthalmic device applications from total applications reviewed

Ophthalmic - 2.4%

Other - 97.6%

Conclusion

The role of the TGA is to regulate therapeutic goods. The TGA does this by applying scientific and clinical expertise to an assessment of the evidence of the risks compared to the benefits of use of therapeutic goods. The role of supporting clinical evidence in the evaluation of medical devices in general, and ophthalmic medical devices in particular, is fundamental.

References

  1. Feldman, Mitchell D., et al. "Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment." Journal of general internal medicine 23.1 (2008): 57-63.
  2. Hwang, Jenny, Thomas J. Hwang, and Joseph B. Ciolino. "Pivotal clinical trials of novel ophthalmic drugs and medical devices: retrospective observational study, 2002-2012." BMJ open 5.6 (2015): e007987.
  3. Medical Device Standards Order (Standards for Clinical Evidence) 2008
  4. ISO 11979-7: 2006 Ophthalmic implants - Intraocular lenses -- Part 7: Clinical investigations (updated in 2014)
  5. ANSI (American National Standards Institute) standard Z80.27 on Implantable Glaucoma Devices
  6. Performance Statistics Report - June 2015 - June 2016 (pdf, 855kb)