TGA appears to have postponed implementation of the new IVD regulations into 2010.  This follows considerable difficulty with establishing a mechanism for dealing with the large bulk of IVDs used in Australia which are imported.  There's no equivalent of the CE certificate availabe for most of these devices - as the proposed TGA system captures many IVDs which are self certified in Europe.

For more information - come along to the IVds session at Ausbiotech 2009 to hear about the latest developments in Australia and internationally in IVD regulations.  Click here to download the full conference program.

 TGA have published their plans for the long awaited new regulatory framework for IVDs. This follows the consultations conducted as part of the proposed development of the Trans Tasman ANZTPA agency arrangements. The system will be based upon a conformity assessment model with risk based classifications determining the level of regulatory review. This regulation will be implemented by bringing IVDs within the scope of the existing Therapeutic Goods Regulations (Medical Devices) 2002. This is a change in regulation without modification to the primary legislation in the Therapeutic Goods Act - there is no need to introduce a new bill and the change will be achieved by means of simply tabling the revision in parliament as a 15-day disallowable instrument. TGA plan to introduce the amendments into parliament in the third quarter of 2009 with implementation of the new system before the end of the year. As was the case for the introduction of the harmonised devices regulations, after implementation there will be a four year transition period before the new framework becomes mandatory.

Exemptions to end

Most IVDs are currently exempt from TGA regulation. This will change when the new classifications come into force. The classification and conformity assessment arrangements broadly mirror the European IVDD requirements, although the classification arrangements have some significant differences in the detail.  Click here for a detailed comparison of the new Australian and existing European IVDD classifications.

TGA/NATA joint oversight of in-house tests

Currently all in house tests – conducted entirely within a laboratory or lab network are outside of the scope of TGA regulation. Under the new arrangements TGA will require that all such tests be NATA accredited, and will directly assess the highest risk (Class 4) tests. TGA will also begin data sharing with NATA to police the new regulations.

Questions remain over third party assessment

Key questions remain about the implementation. In particular this change is set against the background of current consultation regarding implementation of third party conformity assessment in Australia. The current proposal for TGA keeps the requirement for direct TGA conformity assessment of Australian manufacturers of IVDs. However there are signs of movement. Interestingly the TGA proposal talks in terms of TGA or other acceptable manufacturer certification being required for the lower risk IVDs.

TGA have learned form the implementation of transitional arrangements from the introduction of the devices regulations. Fee structures will not penalise those manufacturers or sponsors who choose to transition early in the 4 year transition period, hopefully avoiding the last minute rush which overloaded the review capacity of TGA as the devices transition came to an end.

On 5^th November 2008 TGA will launch the much anticipated, and needed, revision to its online SIME system. The new Electronic Business Services (eBS) is a complete redesign of the existing system and will provide a single portal for all electronic facilities with the TGA in medical device and medicines applications, manufacturers evidence, access to the ARTG and administrative details. The changes are both cosmetic and functional.

Immediate approval for Class I devices

The most hotly anticipated change will be the automatic inclusion of Class I (non-sterile, non-measuring) on to the ARTG. This move will align practices with the original intent of the legislation and bring Australian practices closer to those seen in Europe and America for many years. From the 5^th of November TGA intends all Class I devices will be included on the ARTG within 24 hours of submitting the application online.

This new approach to Class I devices is a welcome improvement on current practices which saw lengthy increases in time-to-market for many companies.

The change will include a revised list of questions in the online application form to provide greater validation that the device meets the classifications requirements for the Class I device. There will also be greater checks on the Intended Purpose, including a list of Restricted and Prohibited words for Class I applications. Use of these words within the Intended Purpose will either flag the application or prevent its submission. TGA has published a first draft of the "Prohibited/Restricted Word List". The list clearly aims to capture things like biological products, implants, diagnostics and devices which include medicines. However it's potentially a fairly blunt instrument. For example applications containing the words caliper, trial, and prosthesis are widely used to describe a range of genuinely class I devices. TGA has given assurances that the word check will be a brief review only so should not unduly delay legitimate Class I applications.

Class I devices will be controlled through a greater emphasis on postmarket monitoring, a growing world-wide regulatory trend. There will be three levels of postmarket reviews; Targeted Level 1, Targeted Level 2 and Random. Use of a restricted word in the intended purpose will automatically result in a Level 1 review. This review will examine the appropriateness of the classification, GMDN code and Intended Purpose, it will not review the technical file. Targeted Level 2 reviews will be conducted due to a number of reasons including among others; outcomes of Level 1 reviews, trends in IRIS reports, repeated breaches of the advertising code and recalls. Finally, random Level 1 and Level 2 reviews will be conducted.

Worth Waiting...?

For those with applications currently in draft it must be noted that on the 29^th October all Class I applications in draft will be deleted by the TGA. All other applications will be retained; however you may be required to complete additional fields to validate the submission. Any application that has already been lodged with the TGA will continue to be processed in the old system. If you are close to submitting a Class I application, it may be worthwhile holding off until after the 5^th November.

More detailed information is available at TGAs eBS help page.

Manufacturer's Evidence

Another welcome change in the works at TGA is the automation of new or revised manufacturers' evidence and the introduction of a combined device application and conformity assessment process. This new process is currently slated to be implemented in May 2009. Currently the two processes run in series, with lengthy queuing delays.

Currently the rejection rate of manufacturers' evidence is approximately 45%, the TGA wishes to reduce this to 10% before implementing the combined assessment process. The TGA will undergo a sponsor teaching process in an attempt to reduce this rejection rate. The high rejection rate is primarily due to sponsors not providing all the necessary documents. The training process will aim to teach sponsors to thoroughly check their applications prior to submitting evidence. For more guidance on the TGA's requirements for manufacturers evidence consult TGA Guidance Document 20 Obligations and responsibilities of medical device sponsors and manufacturers and TGA Devices Fact Sheet 17 Manufacturers' evidence - EC certificates for medical devices

(This article was first published in Australasian Biotechnology 18(2), June 2008. - the official journal of AusBiotech)

Big changes are afoot at TGA as the Australian national regulator struggles to cope with workloads while nursing a hangover from the transition to new medical device regulations. The changes will see priority for speedier assessments of new devices and a wholesale redesign of TGA’s electronic lodgement portal with a move to true notification of Class I devices. On the international front a new MOU with Canada will allow TGA to conduct manufacturer audits in support of Canadian applications. These changes promise faster market access especially for Australian manufacturers, although there remains more to be done, particularly on implementation of 3^rd party assessment.

Newcomers split – to a fast(er) track

The absence of any grandfathering provisions in TGA’s new globally harmonised regulations meant the entire Australian inventory of medical devices required re-assessment prior to the sunset on the old regulations last October. Higher costs and much tougher reviews under new rules caused most manufacturers to wait till just before the deadline before submitting transition applications. The resulting overload forced TGA to pass new legislation allowing continued supply of existing devices pending re-assessment.

More importantly, applications for new medical devices were caught up in the very long queue of transitioning devices. For early stage medical device companies bringing a first product to market, the delayed assessments – often many months over target – were potentially fatal. Following repeated representations from AusMedtech, TGA has split the queue, establishing separate workgroups and management for assessment of new applications and aims to process all future new device applications within target times. AusMedtech will be monitoring TGA’s progress under the new arrangements – watch this space.

New DEAL - Class I take notice

In all major international markets, low risk (Class I) medical devices may be supplied direct to market based on manufacturer self assessment. Australia alone reviews Class I applications prior to grant of marketing approval. Even though these are largely administrative checks, the extra delays in marketing have proven costly, especially to emerging manufacturers. In the second half of 2008 TGA plans to begin roll out of a redesign of its ageing Device Electronic Application Lodgement (DEAL) web portal. The first stage will be a change to true notifications for Class I non-sterile/measuring function applications. Once the application is submitted, the device will be instantaneously entered onto the ARTG and approved for supply, with no review. When complete, the new portal will integrate medicine and device applications and manufacturing assessments, include much more extensive online help and provide access to all client information via a single login point. The redesign is being tested in conjunction with industry associations including AusMedtech.

Postmarket strengthened

Another important change is a beefed up Postmarket review process as counterpoint to the more streamlined premarket systems. Expect more rigorous review of company postmarket monitoring activities, more spot checks on devices and greater TGA attention to adverse events. A proportion of all notified Class I devices will be subject to random postmarket audit.

Unfinished Business

Australian Industry has long lobbied for 3^rd party assessment, the norm in most overseas markets, offering the potential for multiple market entry via a single assessor. TGA had committed to 3^rd Party as part of the stalled “Trans Tasman” ANZTPA negotiations however there’s still little sign of progress and this is very much unfinished business for AusMedtech, which will continue to press for introduction of 3^rd Party assessment of medical devices in Australia.

(This article is based on a column written for Australasian Biotechnology - the official journal of AusBiotech and on a detailed paper The Case for Third Party Assessment prepared for AusBiotech)

Political opposition from the complementary medicines sector in New Zealand, has led to the indefinite postponement of the joint Australia-NZ Therapeutics Products Agency (ANZTPA). This raises questions over the future of some proposed reforms - in particular the introduction of third party assessment for medical devices, which has been long resisted in Australia, but strongly supported by New Zealand and slated to be introduced as part of the ANZTPA package.

Rapid and cost effective regulatory oversight through 3rd Party assessment is available in North America, Europe and Japan for the overwhelming majority of devices. The real value of third party assessment comes from the accreditation of assessors in multiple jurisdictions. One assessor may be accredited as a European Notified Body, and also to make Canadian CMDCAS assessments, US 510(k) reviews and Japanese PAL reviews. For manufacturers, this means a very considerable saving in costs and much more rapid and widespread market access:

• multiple reviews can be conducted as part of a single audit visit, and
• multiple approvals can be based upon assessment of a single Technical File.

Quicker, cheaper, better

Overseas experience with 3rd Party assessment has reinforced the effectiveness of the practice. A recently completed review of European regulations has resulted in a number of significant changes to underlying technical regulations, but no change at all to the use of Notified Bodies. The US FDA in a 2002 review reported:

'During fiscal year 2002, 510(k)'s reviewed by Accredited Persons received FDA marketing clearance in an average of 77 days after initial receipt by the Accredited Person - 29% faster than comparable 510(k)'s reviewed entirely by FDA. Most Accredited Persons have specialized expertise in areas that may be helpful to 510(k) submitters, such as device testing, standards, or foreign regulatory requirements. Further, Accredited Persons have headquarters throughout the United States, in Europe, and in Taiwan, and have additional offices elsewhere, so they often can provide local service'

Australian Regulations a competitive disadvantage for Australian manufacturers

Perhaps the most bizarre feature of current Australian requirements is that TGA already recognizes 3rd Party assessments of overseas manufacturers. Given the existing TGA practice of accepting CE certificates of overseas manufactured devices from European Notified Bodies in lieu of TGA certification, it is possible for a manufacturer to deal with a single assessor to obtain approvals in all major jurisdictions, including Australia, unless the product is made in Australia by an Australian manufacturer in which case a separate assessment by TGA is required irrespective of overseas assessments.

Given the current blow-out in regulatory approval times caused by the October 2007 sunset on the transition to the new Australian regulations and the need for reassessment of the entire Australian inventory, this need for Australian manufacturers to join an already very long queue is especially harsh.