US Medical Device manufacturers supporting Australia’s growing Health Care needs.

I was most privileged to be invited at a recent reception, hosted in April 2017, by the U.S. Consul General Mrs Fowler, in Double Bay, Sydney Australia.

The event, appropriately named Patient Day 2017 “Saving Lives through American Innovation” highlighted the immense contributions by US Medical Device manufacturers with much needed products for Australia.

I for one, was most touched by speeches made from three beneficiaries of products from Johnson and Johnson, Medtronic and Varian Medical Systems. Products, seen as having clearly contributed to the improved quality of life for those wonderful individuals.

At least for myself at a tender age from a bygone era in the 50’s, I know for sure that at one point in time and hopefully in the very far distant future, advances in Medical Device technologies would also allow me to also enjoy the same quality of life as I am enjoying today. As of now, everything looks good, possibly because of our vegemite , our beautiful weather ( and of course the odd exercise or three!!)

So how does the American sourced Medical Devices landscape look like in Australia.

A review of Medical Device approvals on the Therapeutic Goods Administration (TGA) website indicates that the largest number are for products manufactured in USA at 36.9 % of total approvals compared to 7.7% for products manufactured in Australia, 14% from Germany, 8.2% from China, 3.4% from France and only 0.3% from India.

In general terms, Medical Devices are assigned to one of five risk classifications, the lowest classification (Class I) equating to a low risk to end users with the highest risk (Class III,AIMD) given to products with the highest potential risk to end users.

In any circumstances, Medical Devices are required to comply to particular regulatory requirements to ensure Quality, Safety and Clinical efficacy. The risk classification is a mean to determine types of documents required to be assessed prior to TGA authorisation for supply.

Again, when one looks further at total Medical Device approvals, US leads the pack with 32.6% for the lowest risk (Class I) and bumper figures of 58.0% for the high risk III and 75.8% for AIMD (Active Implantable Medical Devices).

Remarkable figures attesting to the well regarded high quality and most advanced products from US.

RQSolutions ( is a team of strategic professionals with over 35 years in Medical Device Sponsorship, Registrations, Government Reimbursement and Quality Management in the Therapeutic Goods Industry. We have provided assistance to a large number of US clients.

Let us share with you, the various available options to register your Medical Devices in Australia.

We love to hear from you.

Critical changes restricting the importation of Medical Devicesto Australia from 1 December 2016.

Medical Devices must be registered with the Australian Health Authority, the Therapeutic Goods Administration (TGA) before they are authorised for supply in the market.
Respective Medical Device applications are submitted by the Australian sponsor for assessment and where the risk classification is greater than I (inclusive of Is and Im), a European CE Certificate is used as one of TGA’s key assessable documents to qualify that the product has met the EU directive 93/42/eec or 90/385/eec.
CE certificates are issued by Notified Bodies to manufacturers in their capacity either as ORIGINAL EQUIPMENT (medical device) Manufacturers(OEM) or OWN BRAND LABELLING Manufacturers(OBL).
Following the publication of EU recommendation 2013/473/EU, OBL CE certification of Medical Devices,will no longer apply from 1 December 2016. In that circumstance, product registrations with the TGA using the OBL approach will no longer be valid.
EU recommendation 2013/473/EU now dictates that a full conformity assessment by the certifying Notified Body must be carried out as per applicable directives when compared to the previous reduced assessments on OBL manufacturers.

What does it all mean:

The current OBL manufacturer must hold the complete technical file for related approved products covered in the scope of his new CE certification.

Unless the OEM manufacturer is willing to share all product related design, process documentation etc., an unlikely contractual agreement in most situations, the OBL certification will be terminated on 1 December 2016 by the respective Notified Body.

Such decision will affect many thousands of products currently on the Australian Register of Therapeutic Goods (ARTG) and potentially many more thousands of approved products in other regulated countries where regulatory requirements include the submission of CE certificates.
To summarise, if the manufacturer cannot support EU recommendation 2013/473/EUto support continual certification, the Australian sponsor can no longer supply the device in Australia after 1 December 2016.
RQSolutions ( is a team of strategic professionals with over 35 years in Medical Device Sponsorship, Registrations, Government Reimbursement and Quality Management in the Therapeutic Goods Industry.

Let us share with you, the various available options to register your Medical Devices in Australia. We look forward to hearing from you.

The significance of the Australian Declaration of Conformity for Medical Devices


The Australian Declaration of Conformity (DoC) for medical devices is a required document by both the Therapeutic Goods Administration (TGA)and the Australian Communications and Media Authority (ACMA).

The verbiage implies that products supplied to Australia or exported from Australia, comply with the Essential Principles (EPs), the classification rules as well as conforming to adequate conformity assessment procedures and related standards.
This applies to any device whether it is produced locally or intended to be imported to Australia. It makes the word ‘supplier’ an umbrella term that covers manufacturers, importers, wholesalers, or any other authorized representative.

Significance from TGA perspective

In the context of the medical device pre-market registration procedure and post market approval process with the TGA, the regulatory body requires suppliers to have a DoC cover three main compliance aspects:

1. Compliance with EPs that are detailed in the Medical Devices Therapeutic Act and Regulations, anddivided into two main categories:

• General principles, applicable to all the devices. These are related to health and safety, including the long termsafety, the suitability of the device according to its intended purpose, the transport and storage requirements, and associated benefits/adverse effects .

• Design and construction principles that are specific to the intended purpose and properties of the medical device. Those specific principles are related to the chemical, physical and biological properties, infection and microbial contamination, construction and environmental properties, specificities if any measuring function, radiation, connection or inclusion of an energy source in the device, information to be provided with medical devices, and the clinical evidence.

2. Applicable classification rules.

3. Conformity assessment adequate procedures, which the manufacturer is responsible to choose and which relies on the classification level of the medical device. Indeed, TGA provides six templates and gives orientation about how to fill each one. There are some classes where several templates can be used alternatively depending on the classification rule used for the device to register.

Significance from ACMA perspective

ACMA is the second regulatory body involved in the conformity assessment of a medical device when it is under one of the following categories:

  • Telecommunications customer equipment (CE) and customer cabling (CC).
  • Radio communications devices.
  • Electromagnetic compatibility (EMC) performance of electrical and electronic devices, vehicles and devices with internal combustion engines.
  • Electromagnetic energy (EME) from radio transmitters.

According to each category, ACMA gives direction about the compliance procedure, involving several steps.After showing compliance by submitting a labelling notice, identifying relevant technical standards and testing requirements and applying them to the medical device, suppliers are required to complete a DoC, in order to be able to register (or renew registration of) the device into the national database for one year. The supplier is then considered to be ‘responsible’. This step is also crucial in order to obtain the Regulatory Compliance Mark (RCM), which is an official label that proves that the medical device complies with the standard applied.
To note that the registration to the national database does not exempt suppliers from registration with other regulatory bodies such as the Electrical Regulatory Authorities Council (ERAC) to substantiate electrical safety, although the same database is used in this case.

How TGA and ACMA processes are interrelated

After confirming compliance with adequate conformity assessment procedures, TGA issues certification while ACMA is responsible then to register the device in its national database where labels will require the inclusion of the Regulatory Compliance Mark (RCM). ACMA can also require any related documentation for potential audits.

Significance in terms of advantages

The DoC grants several advantages for suppliers and the manufacturer.
Indeed, the sign off of the DoC by the manufacturer attests that associated products comply with the Essential principles. Additional conditions can refer to required notifications by the manufacturer to the supplier where substantial changes to the product are undertaken orwhere post market complaints and Adverse events are reported in geographies other than where the product is approved.
On the basis that the content of the TGA template is not inclusive, the document can also include a reference to not only the parent product but all associated approved variances of the same product with the same intended purpose. A tabular representation could have all respective catalogue numbers with Label and Instructions for Use as attachments, forming referenced approved materials as a cross check to product approved for supply.


The DoC is considered a powerful document committing both manufacturer and supplier to compliance requirements. The DoC, where additional inclusions of particular clauses in TGA provided templates, can be regarded as a contractual agreement duly signed by the importer and the manufacturer of the associate product.
RQSolutions ( services the global Therapeutic Goods Industry, with over 35 years’ expertise, in Sponsorship, TGA Registrations, PLAC related Government Reimbursement, ISO13485 based Quality Management and document management optimisation. We are based in Australia and a heartbeat away from our colleagues at the TGA. Let us share with you, the various available options to register your Medical Devices in Australia. We look forward to hearing from you to

European Union (EU) Essential Requirements Checklist and the Australian Principles Checklist for Medical Devices-Significance in a technical file and differences


The Australian Essential Principles Checklist (AEPC) is a list of 15 general and specific rules set by the Therapeutic and Good Administration (TGA). These, assist and simplify the assessment of a device’s efficacy and safety based on information provided in the associated technical file.
AEPC 15 apply specifically to IVD products. The AEPC justifies the compliance of the devices to the standards chosen by the manufacturer and the reason if not applicable.
The European Essential Requirements Checklist (EUERC) is the European analogue of the AEPC, it has the sameoverall purpose with very similar verbiage in most circumstances but it includes only 13 principles. The EUERC is now formalised in standard ISO/TR 16142.
Both are auditable documents when technical files are reviewed by relevant authorities for products of all risk classifications.

The role and importance of AEPC and EUERC

The AEPC and the EUERC can be considered as the first referenced documents in your technical file built up. In a well prepared technical file, both checklists are used as referenced content lists of your dossier with links to updatable sections of that dossier.
This is largely depended on the manner documents are managed and controlled. The checklist and related clausesbecome the first step towards the elaboration of the technical file by the manufacturer, based on the type of device, its design, manufacture, function, composition, use, claims, and clinical evaluation.
Moreover, it assists the manufacturer to choose the appropriate standard or related documentation to follow and which, in most circumstances makes the checklist an acceptable referenced document.
Particular caution for submissions for Australia as the only acceptable assessable document is the AEPC. Where the applicant uses the EUERC for Australia then an add-on document must be included to show that requirements meeting the gaps between the two checklists have been identified and met.
An additional point of caution nevertheless of the presumption that meeting a standard means meeting the associated clause of the essential R/P checklist. This is not true as the intent ultimately is to ensure a correct validated methodology approach has been taken to substantiate the safety and efficacy of the product.

Key Differences between EP and ER

The following table shows where EP and ER are different and what the related specificities are


All elements of theAEPC and the EUERCneed to be assessed when compiling the checklist. Even though both are very similar, there are several subtle differences that should be consideredat the initial stage of technical file preparation.
Where medical device applications are submitted for either Australia and Europe, a gap analysis between both checklists at the onset will ensure the completeness of the document to the relevant authority.
RQSolutions can supply ready-made templates addressing combined elements of both AEPC and the EUERC. These can be made available on request to

RQSolutions ( services the global Therapeutic Goods Industry, with over 35 years’ expertise, in Sponsorship, TGA Registrations, PLAC related Government Reimbursement,ISO13485 based Quality Management and document management optimisation.We are based in Australia and a heartbeat away from our colleagues at the TGA. Let us share with you, the various available options to register your Medical Devices in Australia. We look forward to hearing from you

The meaning of a Risk Analysis for Medical Devices and its use in the lifetime of a product cycle


Risk analysis is a process where harmful hazards are identified and risk is mitigated when identified with particular correlation of this risk to occurrence rates and severity level. It is part of a larger process called risk assessment, that additionally includes a risk evaluation. Risk assessment itself is part of the risk management process for which, in the case of a medical device, the manufacturer is required to review on a continuous basis, related documentation during the life-cycle of the device. The process then becomes dynamic and continuous as it adapts to internal and external changes.

Regulatory framework in Australia

The driver of the framework is the country’s national legislation and various applicable clauses with a purpose to ensure medical devices conform with regards to quality, safety and effectiveness.
Legislative instruments include the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990, and the Therapeutic Goods (Medical Devices) Regulations 2002.
The Australian authority; Therapeutic Goods Administration (TGA), responsible for assessing medical devices also refer to Australian or the international standards agencies to ensure product compliance with legislation. Manufacturers often use either harmonised standards referenced in the European Commission website or standards published by the International Organization for Standardization (ISO). Some of the more frequented standards are as follows:

  • ISO 14971—Application of risk management to medical devices;
  • ISO 13485—Quality management systems: Requirements for regulatory purposes;
  • ISO 10993—Biological evaluation of medical devices;
  • ISO 60601—Medical electrical equipment.

Why is risk analysis important for medical devices?

Risk analysis is particularly important for medical devices for the assessment of benefits and potential risks through qualitative and quantitative characteristics that could affect the safety of the medical device and, where appropriate, their defined limits; as well as to estimate the risk of hazardous event by studying a group of events that can lead to such situation (ISO 14971). It is often referred to as “the right thing to do” because it is considered obligatory in that, it protects the user of the device, product, brand and manufacturer’s credibility and minimises associated costs where recalls become a necessity.

When does TGA require risk analysis and what documents are needed?

TGA requires that the necessary documentation is made available for assessment (including the Australian Declaration of Conformity) when applications are made for the registration of medical devices and the subsequent inclusion of the product in the Australian Register of Therapeutic Goods (ARTG)
The risk report is an assessable document for products with a risk classification of III and AIMD and where the TGA audits applications during their ongoing monitoring process of approved products on the ARTG.
• Risk management documentation should include:

  • The risk plan
  • Tabulated risk management assessments with their associated severity tables
  • A statement of compliance with clauses of the EP.
  • Referenced documents supporting compliance (test reports, assessment reports etc.)

The Risk Management report is therefore a key document and the write up and related format to be as close as possible to the requirements of ISO 14971. Effectively, it is meant to provide a thorough analysis to ensure safeguards are in place with the use of the device and the use of proper identification of all benefit/risk factors.
There are other steps where the risk analysis as well as its evaluation is important:
– In the preparation of the information on benefits and risks to include in the instructions of use, for TGA approval;
– for an optimal and quick communication with TGA if any change that impacts the benefits and risk balance, especially if related to the usage of the device;
– when any adverse event is reported (post market) and;
– in the compulsory reassessment of the risk by the manufacturer, in case of death or serious injury reported after classifying the risk as acceptable.

Essential Principles (EP)to comply with

TGA requires that products meet EP to successfully register medical devices for supply in Australia. Table 1 summarizes those EP for risk analysis:

Specific medical devices particularities

1. Active medical devices

Active medical devices are devices that use energy for functionality and as such, specific requirements apply.
Electromedical safety standards are often referred to, for electrically powered products from the high risk medical devices such as pacemakers to the lower risk products such as blood-pressure monitors. Compliance to at least EP 9.2 and 12 becoming critical for the assessment of associated risks.
Where there is interaction with other electromedical devices, related clauses found in most part of the IEC61000 family of standards are used to cover electromagnetic compatibility (EMC).

2. Other specific devices

For devices with medicinal substances, the risk analysis will incorporate interactive assessments of the combination product and as in all medical devices a review where substantial changes occur. A determination of a risk will then be followed with an update of associated documents pertaining to revalidation tasks to ensure continual safety of the product and the maintenance of its intended purpose.
For medical devices containing materials of animal, microbial or recombinant origin, the performed risk analysis should consider potential contamination from such sources as well as any potential change related to the material or manufacturing process.


Risk analysis is a crucial step in the life cycle of a medical device. Compliance with clauses of the EP and in conjunction with the use of ISO14971 will ensure that hazards are identified and action plans are in place to maximise patient safety and minimise product related failure events.

Additional references

RQSolutions is a team of strategic professionals with over 25 years in Product Registrations and Quality Management in the Health Care Industry. Should you require to contact them, please email the founder George Azoury on

Particular clinical requirements for orthopedic products when applications are submitted for assessment by the TGA, PLAC, EU authorities


Orthopedic products fit into one or more category of medical devices depending on the regulatory authority. Indeed, Prostheses List Advisory Committee (PLAC) considers them as prostheses devices (single or system product) or being in the human tissue category while the Therapeutic Good Administration (TGA) classifies them as joint prostheses or passive implantable medical devices and European authorities (EU) offers a flexible guidance regarding medical devices’ clinical evidence in general. The International Medical Device Regulators Forum (IMDRF) draws an international guideline that aims to harmonize processes and requirements worldwide and the present article builds on that regarding the specific requirements applied to orthopedic products.

Technical aspects

TGA and EU always require to submit an overall clinical evidence summary including the Clinical Evaluation Report (CER) with risk analysis and quality management elaborated and signed by a competent clinical expert, whose choice is justified by the sponsor, the device specific clinical trials described in detail, a clinical literature review (and other reasonable known information) with full text key articles and translations if needed. If no literature was found, a justification should be submitted.Other clinical evidence may be submitted.
The application format for PLAC is based on the category of application (new listing, expand billing code, compress billing codes or amend listing). Overall, the following sections are related to the clinical evidence:proposed benefits (for new listing) or reasons (for expansion, compression or amendment), comparators, product setting and product purpose, overseas status and comparative clinical assessment and supportive literature.

Substantial aspects

1. It is required to provide sufficient and appropriate clinical evidence that makes the device under application meet the regulatory requirements in terms of safety and performance.

2. The nature, probability, extent, duration and frequency of benefits and risk should be provided. TGA highly recommends that for joint prostheses to list possible combinationswith other devices or components (with provision of the lineage when it is a modular system) and prove the effectiveness and safety of such combination.It requires to support particularly the safety of orthopedic implants in Magnetic Resonance Imaging (MRI) environment tested using international standards (but not necessarily clinical data).

3. Demonstrating substantial clinical equivalence in case of comparative clinical evidence (versus other device) based on technical, biological and clinical characteristics (generally no gap in safety and effectiveness, similar design, use).
Additionally, EU specifies other requirements such as similar targeted population.

4. The more the device is sensitive the more clinical data are required (in quantity and quality) in general. High-risk joint prostheses and orthopedic implants, as well as devices with little or no experience, and those that extend the intended purpose of an existing technology are the most concerned. If lack of data, a detailed justification is required, as it is the case for devices of unmet medical needs where no similar product is available.However, less data is needed when it is a well-established technology for instance.The PLAC will generally require more data when claiming for superiority than when claiming for non-inferiority.

5. High quality, scientifically valid with rigorous methodology studies are encouraged to be submitted to support application.

Typical high quality studies use a comparison (Preferably the device under application should be one of the comparators or alternatively similar devices versus one another), are large, well-designed, with appropriate follow-up time (i.e. two years for joint prostheses in Australia), published and peer reviewed studies.

Rigorous methodologytakes into account epidemiological, statistical, ethical aspects, and uses for instance international guidelines in the reporting such as the International Standard Order (ISO) 14155 orConsolidated Standards of Reporting Trials (CONSORT).

6. Primary clinical studies outcomes should be whether specific patient scores (internationally recognized assessment tool such as Harris Hip Score) for patient performance data; or demonstrating the durability of the product through studies with appropriate follow-up time and based on information provided by using an international joint registry (TGA) or Australia’s National Joint Replacement Registry (PLAC) for revision data. However, for the TGA, surrogate markers or alternatively post-market data are used to assess to the risk of delayed need in revision surgery for joint prostheses.
7. The level of evidence should be taken into account for submitted studies. Generally, an individual randomized controlled trial is considered to provide a higher level of evidence than a cohort study. It is advised to refer to international and national guidelines about the level of evidence (Grading of Recommendations Assessment, Development and Evaluation (GRADE), Australian National Health and Medical Research Council).

8. The body of evidence should be taken into account. It includes the level of evidence, number and quality of studies, effect size, the statistical and clinical significance of the results and the relevance to clinical practice.

9. Additionally, the CER and literature review should rely on robust sources like scientific literature databases (i.e.Pubmed, Embase, Cochrane Central trials register), internet searches (i.e.World Health Organization, national and international registries) ornon-published data (i.e. manufacturing data). The literature review should use appropriate, systematic and non-biased methods such as the Cochrane Handbook for Systematic Reviews of Interventions and PRISMA (The Preferred Reporting Items for Systematic Reviews and Meta-Analyses) Statement. It should be critical with reference to both positive and negative studies results objectively assessed.

10. Experts should be qualified according to the device assessed and any conflict of interest should be mentioned. They are contracted by the sponsor for the CER elaboration (TGA, EU) and they are part of the Clinical Advisory Groups (CAGs) or Panel of Clinical Experts(PoCE)for PLAC’s application.

11. Adverse events should be appropriately mitigated (before applying) and/or included in the information supplied with the device.

12. Submission to PLAC requires successful registration in the Australian Register of Therapeutic Goods(ARTG), only comparative clinical effectiveness supported by only high quality studies with positive results in human settings (if not available, justification is needed).

13. The PLAC requires a length of follow up of 10 years for major joint replacement prosthesis claiming superior clinical performance, 2 years for major joint replacement prosthesis claiming noninferiority, and 1 year for bioresorbable screw, polypin resorbable bone pin and mesh.


The clinical data submitted to the EU, TGA and PLAC in terms of quality as well as quantity are decisive for the acceptance or the rejection of the application. A specific and keen attention should be paid for high-risk devices such as joint prostheses and orthopedic implants.

Reimbursement of Medical Devices in Australia and outlook 2017


The medical technology industry in Australia was estimated to be 10 billion AUS $ in 2012,with an expenditure (excluding related services) representing 3.3% of total health expenses. It accounts for19,000 employees and over 41,000 registered medical devices (Ispor 2016).
The industry is growing fast. Indeed, the Compound Annual Growth Rate (CAGR) was estimated to be 9% per year until 2017 at least and the current transition toward the digitalization of health showingencouraging and increasing investment in the sector. It has the particularity that almost all the local production is exported while the largest majority of products used in the country are imported (The Canadian Trade Commissioner Service 2012).

Health leadership body involved in the medical devices’ industry regulation, registration and reimbursement processes

1. Overview

Figure 1 below, summarizes the entities involved in the decision-making process regarding medical devices industry in Australia.

Acronyms (by alphabetical order):
ACMD: Advisory Committee on Medical Devices
DoH: Department of Health (Australian Government)
ESC: Evaluation Sub-Committee
HESC: Health Economics Sub-Committee
HTA groups: Health Technology Assessment groups
IHPA: Independent Hospital Pricing Authority
MBS: Medical Benefits Scheme
MoH: Ministry of Health
MSAC: Medical Services Advisory Committee
PASC: Protocol Advisory Sub Committee
PLAC: Prostheses List Advisory Committee
TGA: Therapeutic Goods Administration

2. Regulatory process for registrations and market access

a. Registration
Allows commercializing the medical device in Australia and can be summarized in the following steps:
1. Where possible and mostly for new technologies, the applicant meets with the DoH to discuss the intended product.
2. Eligibility assessment can be undertaken by the DoH based on PASC clinical expertise and covering required registration submissionsto theTGA.
3. Protocol setting by the PASC to guide the assessment of the product. In normal circumstances, it will contain basic information, any detail about the clinical added value and cost-effectiveness evidence and its elaboration takes around 8 months and involves the applicant, independent contracted HTA group, clinical experts and the public.
4. Evidence evaluation that involves HTA groups, ESC, MSAC and DoH as the final decision maker.
5. In case of device/service approval, DoH is responsible to implement the changes: e.g. Integration of the newly registered medical device to the Medicare Benefits Schedule.

b. Market access

In order to be subject to reimbursement by the Private Health Insurance (PHI), implantable devices should be listed in the Prostheses List (PL). There are two different listing processes, based on whether the similar device is already in PL or not:
1. If yes, an application of non-inferiority should be submitted to PLAC.
a. This process is straight forward as the application requires the submission of information claiming substantial equivalence to a comparator product that is already on the PL. The allocated benefit for the subject product in this regard will also be equivalent
2. If the device is innovative and with an application concurrently and sometimes initiated at different times to the TGA, the application to PLAC should contain claims of superiority. In this case, the process is tighter and longer (over 1 year) and often involves HESC reviewing the application.
Only implantable devices are included in the PL. Other external devices are not.
The Independent Hospital Pricing Authority (IHPA) is the official body that regulates the medical devices prices in the public sector. It defines the ratesfunded by the Government,through the National Efficient Price (NEP) in the public hospitals and the National Effective Costs (NEC) for any other health care facility such as rural hospitals.

Who pays for medical devices?

Implantable medical devices are free of charge for patients under the public hospitals and they are funded by the Government (except for some surgical procedures); while in the private sector they are mainly reimbursedby PHI, based on the benefits defined by PL. In PL, the implantable devices can be:
1. No-gap devices: for which only one benefit is defined and has to be refunded by the PHI.
2. Gap-permitted devices: for which there is currently one listed value listed
About 47% of the population has a subscription to PHI that takes in charge health expenses in private hospitals as well as forother complimentary services such as dental care, optical services and physiotherapy (Ispor 2016).
PL is crucial to access to medical devices reimbursement. For instance, private hospitals cover 90% of gastric intervention related to obesity treatment and other interventions’ demand such as knees and hip replacement interventions increased by 67% and 40% respectively between 2001 and 2012, making the private sector of great support to the public sector allowing patient to access its services at affordable prices generally(The Canadian Trade Commissioner Service 2012).

Challenges and perspectives

There are many current challenges in the reimbursement framework for medical devices in Australia. Indeed, there are differences between public and private hospitals as well as in the prices between both (in the cardiac devices between both) that may lead to unbalanced access and health disparities. Additionally, the big medical devices companies are advantaged, making competition very limited; the PL’s benefits are reduced for some categories, increased for others and discouraging innovative devices making its re-examination necessary; there is no capitalization of health payers on the Clinical Registries data; and duplicate regulatory processes such as the safety evaluation by the PLAC as well as the TGA makes the legal processes longer and ineffective.Finally, the PL has not been updated for a long time to respond to the several changes in health needs of the population and trade such as the increase of chronic diseases, ageing of the population and inflation of 2.8% annually (Medical Technology Association of Australia 2015).
The legal reimbursement framework and PL should encourage more competitive and sustainable pricing and at the same time ensure that patient has access to safe, adequate and cost-effective products from PL. Efforts to improve transparency and simplify the regulatory processes are also awaited.


There are positive and encouraging steps forward for the medical device industry regulation. In 2016, extensive updates in the PL has been initiated and an online application platform called the Prostheses List Management System (PLMS) has been launched, in order to simplify administrative procedures for the purpose of improved efficiency and accuracy. This is at least one step in the right direction.


(The Canadian Trade Commissioner Service 2012)
(Ispor 2016)
(Medical Technology Association of Australia 2015)!ut/p/a1/nZDLTsMwEEV_hS6ytMZx3MRZpggJlUpFKqiNN5VfUFex42IXUb4e5wPKa3Yjzdw5c4DDDrgX7_ZVJDt6MUw9r_fl-hbfLyle4ape4O7uYf382DLCNgS2wIErn0I6QB8GF2_U6JPxqcDxEpNxBZbnaL2J8WCGUGAhx3OaBsPbeDQqTftBWQ192balLKVGiqkG0UpTJJgUSLeEUiNr3czrDNRnIHylOvwr3u8T-nyiuZpBCGz-yLz8CSo_ZY-nE–yysneR4Ldv1wG51h1Qf7z6cVtu9nsCy4ydtY!/dl5/d5/L2dBISEvZ0FBIS9nQSEh/

Medical Device Industry Australia: Outlook for 2017


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.

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.


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2. Expert Review of Medicines and Medical Devices Regulation [WWW Document], n.d. [WWW Document]. Department of Health. URL (accessed 10.1.16).
3. Medicines and medical devices regulation review [WWW Document], n.d. [WWW Document]. Therapeutic Goods Administration (TGA). URL (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
5. Regulatory decisions & notices (medical devices & IVDs) [WWW Document], n.d. [WWW Document]. Therapeutic Goods Administration (TGA). URL (accessed 10.1.16).
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