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Medical Device Industry Australia: Outlook for 2017

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Apr 11 2017
Categories : Uncategorized
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Author : admin

Introduction

The medical technology industry is vast and rapidly growing, and largely covering the medical device sector. A gradual expansion of medical device industry is clearly seen asmainly due to affordability across the globe, the longer survival rate of people and the very obvious improved quality of life.
Data provided by Frost and Sullivan on the global advanced medical technology market indicates 18.5% (US$63.5 billion) of the total worth of the global market is in the Asia-Pacific region, including Australia with a market share of 1.98% (US$6.81 billion) in 2012.

Present and Future of Medical device industry in Australia

The Australian medical device industry fulfilsinternal requirements by focusing on specific marketswith products that add value, the use of skilled labour within the organisation, and investment support for global production. Thirty two recommendations are provided byan independent medical expert panel to the government on 31 March 2015. In its first report on the review of medicines and medical devices emphasises the need for reform to streamline the regulatory framework. The report is concerned with the following points:

  • Marketing approval for a medicine or medical device, utilising evaluationsperformed by equivalent overseas regulators, and the use of expedited evaluations for products for specificconditions;
  • Recognizingequivalent overseas regulators by maintaining transparent measures;
  • Emphasizing post-marketing surveillance of medicines and medical devices and streamliningspecific requirements of post-marketed products listed in the Australian Register of Therapeutic Goods; and
  • Transparency with the use of common standard proceduresto ensurethe timely availability of high quality, safe and efficacious products for Australians.

In the same way, the Australian Government response to the Review of Medicines and Medical Devices Regulation was released on 15 September 2016. This report identifiesmeans to improve the accessibility of the therapeutic goods for consumers and eliminate avoidable formalities for theindustrywithout jeopardising the safety of therapeutic goods in Australia.
The Government has taken a strategic and systematic approach to implementing these concernsin their intended reformsfor future programmes. Recommended implementations, at the same time are intended not to affectthe continuity of business. The Department of Health has been working together, with consumers, health professionals, and industry in order to improve these reforms. Wherever necessary, the TGA recoverstheircosts from industry by ensuringadequate resource availability intended for successful implementation of these reforms without disruption to business. The Government recognizes that consumer, professional, and industry groups are eager for urgent action. Accordingly, the Department of Health is looking at various stagesof implementation of associated recommendations, with anoutlook to execution in 2016-2017.
The suggested recommendation by the Expert Panel and also effort provided by TGA, is set to bring considerable benefits to the Australian public and to the Australian medicine and medical device industry. These benefits include

  • Access to modern and life-saving medical devices will be advanced through expedited pathways for authorization. This will direct to prior access tocritical, life-saving therapies for patients with serious ailments;
  • Rapid access for Australian consumers to certain medical devices that are permitted based on evaluation from equivalent overseas regulators. This will decrease repetition of efforts by the local authority.The TGA nevertheless remains the final decision-making authority, responsible for overseeing all requirements,needed toensure the protection of the Australian consumer but with a primary focus on improved efficiencies;
  • Strengthening of post-marketingsurveillance has thebenefit that it enhances consumer protection by collecting better information about emerging safety issues. This in itself will ensure the accessibility of safe, efficacious and of good qualitydevices for Australian consumers.
  • Special Access Scheme and the Authorised Prescriber Scheme is planned to run smoother and much more rationalized in its formalities to get access of critically needed products under these categories.
  • Openly advertising related complaints about therapeutic goods inclusive of medical deviceswith a stronger emphasis onmisleading claims.

The different strategies will commence in coming year, which includes:

  • No annual charges shall be accrued during the transition periodfor entries in the Australian Register of Therapeutic Goods (ARTG) for IVDs. Annual Charges will commence from 1 July 2017.
  • TGA recognizes the backlog due to pending mandatory audits for certain medical devices. Currently, this creates a delayedcompletion of the clinical assessment component and to some 8-9 months. A large impact onindustry in this circumstance. The TGA is nevertheless hiring additional medical officers and providingrequiring training to perform their functions. In coming years, it is expected that timeframes to product approval will improveto a significant extent.

Conclusion
The future Australian medical device industry isprojectedto maintain ahigh standard level of quality products and an emphasis on faster availability of novel technologies intended to meet the expected demands of the consumer.

References

1. 2016, A. (2016) AusMedtech – Australian medical technology. Available at: http://ausbiotech.org/content.asp?pageid=109 (Accessed: 20 September 2016).
2. Expert Review of Medicines and Medical Devices Regulation [WWW Document], n.d. [WWW Document]. Department of Health. URL http://www.health.gov.au/internet/main/publishing.nsf/content/expert-review-of-medicines-and-medical-devices-regulation (accessed 10.1.16).
3. Medicines and medical devices regulation review [WWW Document], n.d. [WWW Document]. Therapeutic Goods Administration (TGA). URL https://www.tga.gov.au/mmdr#austgovt (accessed 10.1.16).
4. Expert Panel, Review of Medicines and Medical Devices Regulation: Report to the Minister for Health on the Regulatory Framework for Medicines and Medical Devices (31 March 2015) and Report to the Minister for Health on the Regulatory Frameworks for Complementary Medicines and the Advertising of Therapeutic Goods (31 July 2015) available at http://www.health.gov.au/internet/main/publishing.nsf/Content/ExpertReview-of-Medicines-and-Medical-Devices-Regulation
5. Regulatory decisions & notices (medical devices & IVDs) [WWW Document], n.d. [WWW Document]. Therapeutic Goods Administration (TGA). URL https://www.tga.gov.au/regulatory-decisions-notices-medical-devices-ivds (accessed 10.1.16).
6. 2016 Top Markets Report Medical Devices, 2016; International Trade Administration; Online available; Retrieved from: http://trade.gov/topmarkets/pdf/Medical_Devices_Executive_Summary.pdf

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