The new TGA Regulations for IVDs are only days away.  This is a radical change to the regulation of IVDs in Australia which will have far reaching effects on existing and new suppliers looking to market their diagnostics in Australia.  It is vital to understand the changes and carefully plan how your company will work towards meeting all the requirements well within the 4 year transition period.    

For a detailed description of the new regulatory regime, read Senior Consultant Paul Cohen’s article recently published in Australian Journal of Medical Science: 

The changing regulatory environment of in vitro diagnostics: implications for sponsors, manufacturers and laboratory users  

Brandwood Biomedical can provide all of the information and resources you require for your compliance, ensuring that all your IVD products conform to the new Regulatory Framework and may continue to be legally supplied in Australia.

Contact us for a free, no obligation initial consultation on what needs to be done and how we can help. 

Singapore extends deadline for implementation of new medical device regulations

The next phase of implementation of the new Singaporean medical device regulations (based heavily on GHTF) is not far away, with the deadline for implementation of several new requirements and prohibitions pushed back to August 1.

Mandatory registration of all medical devices commenced from May 1, requiring all registration applications to be submitted in the ASEAN CSDT format (similar to the GHTF’s STED) and full fees to be paid for registration.  

Phase 3b of the implementation process will commence from August 1 and will require all manufacturers, importers and licensers dealing with medical devices of all risk classes to hold a Dealer’s License. The supply of Class C and D (equivalent to TGA/European IIb, III and AIMD) devices which are not on the transition list must be registered (unless the device is supplied through the “Authorisation Routes”). The transition list includes Class C and D devices for which pre-market applications were submitted before 30 April 2010.

In addition from 1 August 2011, Class A and B devices must be registered or have an exemption to be supplied.

Annual retention fees will come into place in August 2011 for Class C and D devices, and August 2012 for Class A and B devices (EC/TGA Class I and IIa). Other fees such as change of registrant fee will apply from August this year.

With a direct presence in Singapore and a detailed knowledge of the local requirements, we can help.  Want to learn more about preparing to enter the Singapore market? Contact us to talk. 

AusMedTech 2010

Brandwood Biomedical was delighted to have been associated with a very successful 2010 AusMedTech conference held on 1^st and 2^nd June was a great success achieving the highest attendance to date. The conference sessions were presented by national and international industry speakers and experts in their respective fields.

A recurring theme during the conference was the challenges of entering overseas markets, with particular focus on the USA and on the opportunities offered emerging markets in Asia and particularly China.  For the traditional US markets, apart from the regulatory hurdles, the recent implications of healthcare reform, and the perceived difficulties in raising funds in the U.S as a foreign company, it always came back to the timing of U.S market entry as the key to successfully adding value to the product and product strategy.  Timing is everything in China too, with rapid expansion of the Chinese Healthcare system and associated growth in both public and private sector markets.  At the same time recent regulatory reforms undoubtedly make China one of the world’s most challenging regulatory systems. 

The recent Health Technology Assessment review continues to attract attention in Australia. A key objective of the HTA Review is to address the regulatory burden on business that results from HTA processes, to ensure that those processes are efficient, measured and proportionate. The HTA Review is to identify opportunities for reform of the processes that may be poorly designed, duplicated or unnecessary, imposing unwarranted costs and complexity on business and discouraging innovation.  A lively session with presentations from Warren Bingham (Given Imaging), Sue O’Malley (Medical Intelligence) and TGA’s Brian Richards highlighted the importance of planning clinical evaluations to meet Cost Effectiveness outcomes and the radical changes in the system as a result of the recent review including streamlined and concurrent reviews by different bodies for the same product.  

TGA releases Guidelines for Medical Devices – ARGMD

The Therapeutic Goods Administration has recently published a comprehensive range of free regulatory guidelines for medical devices in Australia – the Australian Regulatory Guidelines for Medical Devices (ARGMD). The guidelines now provide in one place all TGA guidance on regulatory requirements for medical devices. The guidelines have been developed with input from the Australian medical devices industry. The document is to be used for guidance only and supports the legislation provided in the Therapeutic Goods (Medical Devices) Regulations 2002, Therapeutic Goods Act 1989 and Therapeutic Goods Regulations 1990. The document can be accessed here.

Bayesian Statistics – cutting clinical trial size, cost and time to market

On the 5th of February 2010 the FDA issued a new guidance document "Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials".  Use of Bayesian Statistics in clinical trials can achieve outcomes with significantly fewer patients and thus save cost and time.    

The FDA has issued this guidance because, under some circumstances, Bayesian methods provide a less burdensome (i.e. smaller, faster and more cost effective) means of appropriate evaluation of a clinical trial.  This is a significant opportunity - offering the possibility of real savings in time and expense.

For the technically oriented: FDA has adopted an appropriately measured and cautious approach to the introduction of Bayesian methods. This approach does not abandon frequentist analysis (nor should it, since the agency is legimately concerned with the integrity of the regulatory process). Considerations of type I and type II error rates is still required. Neither has the agency agreed to accept prior information based on subjective opinion (however expert).

The main efficiencies will be garnered through the integration of objective prior information from high-quality clinical studies. The process will require substantially more investment in statistical analysis during the design and planning stage, but will reward that investment through substantial down-stream cost savings. It also calls for input from statisticians skilled in Bayesian methods.

Our Clinical Trials Affiliate DevDx Clinical employs some of Australia’s most experienced Biostatisticans with direct and specific expertise in Bayesian statistics and trial design.  Visit www.devdxclinical.com to see how we can help you save costs and shorten time to market through this new opportunity.

 2010 ARCS Conference Report

The 2010 ARCS Congress this year saw a range of topical and interactive workshops and sessions, with DevDx Clinical’s session on Theranostics attracting a lot of attention. Theranostics refers to molecular diagnostic tests and targeted therapeutics in an interdependent, collaborative manner with the goals of personalising treatment by targeting therapy to an individual’s specific disease subtype and genetic profile.  The session was chaired by Arthur Brandwood with main speakers Mervyn Thomas and DevDx Managing Director Paul Cohen. The session discussed the challenges involved in regulation, clinical trial management and statistical analysis of theranostic and diagnostic products.

Are you interested in learning more about personalised medicine? Contact us for more information. Senior consultant Paul Cohen has recently had a relevant article published in Australasian Biotechnology.

Personalised Medicine – Navigating Dx/Rx Co- development (published in Australasian Biotechnology, AusBioTech). 

After protracted consultations, negotiations and rescheduling, the new Australian IVD regulatory framework is finally set to commence on July 1st 2010.  Most IVDs are currently exempt from pre-market approval requirements, but the new system intends to provide regulation for all IVDs.  New IVD products introduced after the commencement date will need to be included on the ARTG by means of a formal application to TGA.    

For devices already on the market before 1st July, a four-year transition period will apply for manufacturers to obtain inclusion on the ARTG.  IVDs introduced on or after 1 July will need ARTG inclusion before they can be supplied.  Do you have an IVD close to market?   Acting before July 1 may buy you four years to upgrade your systems and compliance.   Time is running out for this critical regulatory decision.  Contact us  for more advice on establishing market precedent.

For detailed reviews of the new regulations see the following recently published articles by Brandwood Biomedical Senior Consultant Paul Cohen:

• The changing regulatory environment of in vitro diagnostics: implications for sponsors, manufacturers and laboratory users (published in Australian Journal of Medical Science)

• Personalised Medicine – Navigating Dx/Rx Co- development (published in Australasian Biotechnology, AusBioTech). 

Poor compliance of Class 1 medical devices - TGA crackdown coming?

Recent figures reported by TGA showed that random application audits found 40% of Class I ARTG entries were invalid, leading to cancellation of the ARTG approvals.  Although the availability of direct electronic entry to ARTG for Class I devices is not currently under threat, TGA are currently looking for ways to improve compliance.  Expect more refined targeting mechanisms, and mandatory audits for serial offenders. 

Are you preparing a Class I device submission?  Contact us for advice on ensuring your compliance and so you can submit your entry to ARTG with confidence.

New Team Members Strengthen Reimbursement and Asian Regulatory Expertise

 We are very pleased to welcome our newest team members, Laurence Fong and David Harrison.

• Laurence recently headed up the market access division of leading international consultancy IMS Health and has special expertise in medical device reimbursement.

• David has lengthy experience in regulatory and quality in Asia, with tours of duty in both Tokyo and Beijing for leading international diagnostics and device manufacturers

Watch out for special issues on reimbursement and on Asian regulatory affairs in forthcoming newsletters. 

 New approach for ISO 14155 – International standard for the Clinical Investigation of Medical Devices

A revised version of  the clinical evaluation standard ISO 14155, the international standard for the clinical investigation of medical devices was released earlier this year, and sees a number of updates and changes to the standard. The new standard combines the previous two standards of ISO14155 (Part 1 and 2) into one and has been reformed to level the playing field for clinical investigations conducted around the world – both economically and ethically.

ISO 14155 is not as well recognised as other ISO standards, with Japan and the U.S FDA failing to accept the old standard.  It has been argued that the standard lacks essential details and content, which are challenging to include in a document that needs to be flexible enough to pertain to clinical evaluations conducted all over the world under different conditions. However, the rewrite has been harmonised with ICH GCPs where possible while still remaining device-specific. The new approach deals with clinical research from a project management perspective, with the inclusion of sufficient narrative to teach a sponsor how to conduct a clinical investigation.

DevDx Clinical to sponsor AusMedtech seminar featuring update to ISO 14155

Want to learn more?   DevDx Clinical will host a special seminar on Clinical Trials at the forthcoming AusMedtech conference.   Dr. Danielle Giroud, member of the ISO drafting committee for ISO 14155 will present the changes to ISO 14155.  Click here for a current programme.  To register for the conference click here.

 WMDO – education and development for medical device professionals

WMDO is devoted to providing medical device professionals with a platform for developing their skills and knowledge of various aspects of the industry, from clinical trials and regulatory affairs to project management and sales and marketing.  The world’s only forum dedicated solely to the educational development of the global medical device industry is gathering momentum as the group works to create a novel virtual learning centre.   The organisation is working towards establishing a comprehensive collection of online training courses and resources with input from experts from around the world, with the ultimate aim of providing professionals with globally recognised certification and qualifications.

Brandwood Biomedical senior consultant Paul Cohen has accepted an invitation to join the senior faculty board of WMDO, as expert advisor in medical device regulation and clinical affairs in the Asia Pacific. WMDO will debut in Australia at the AusMedtech conference on 1^st -2^nd June in Sydney.   Click here to learn more about how WMDO can support you and your organisation.

Arthur Brandwood to present at upcoming AusBiotech seminar - Integrating the Regulatory and Product Development Processes

Managing Director Arthur Brandwood will present at an upcoming AusBiotech seminar on 6^th May in Sydney featuring partnership with product development companies.   Arthur’s presentation will focus on integrating regulatory and product development processes and the essential role it plays in accelerating your market access by doing things once and doing them right the first time. Click here for more information and to register for the event.

Congratulations Analytica!

We are pleased to congratulate client Analytica on their recent licensing and distribution partnership with Medical Australia, following their 510(k) clearance in March for their AutoStart Burette and AutoFlush. Analytica’s Autostart Burrette uses a novel design to automatically restart primary infusion once medication is dispensed, through an enhanced float system. Read the Analytica Announcement here.

FDA takes steps toward 510(k) reform

There has been talk of change to the FDA’s 510(k) pre market notification process for some years now. Increasing pressure from lobby groups, plus the changed climate under the current US administration has strengthened the push for reform.  In February a public meeting was held by the FDA to discuss the issues surrounding the 510(k) process and its effectiveness.  Presentations by FDA representatives highlighted FDA concerns related to the current process.

The 510(k) process involves applicants claiming substantial equivalence of a new low risk device to devices already approved. This can allow applicants to compare and liken their devices to those approved up to thirty years ago, creating cause for concern over the effectiveness and validity of the process.  FDA expressed particular concerns that manufacturers have difficulty selecting appropriate predicate devices and prefer to select the "lowest common denominator" device, or a number of devices as predicates to cover all features of the new device.  FDA are considering methods of simplifying and improving the predicate selection process, with suggested ideas including the publication of more information about approved devices, and the restriction of technically obsolete predicates.

Some higher risk devices and life sustaining or implantable devices are currently permitted to apply for approval through the 510(k) process.  A recent report by the U.S Government Accountability Office (GAO) has raised concern over this and recommended a swift issue of regulations for Class III device types currently allowed to enter the market via the 510(k) process.

In addition, FDA expressed concern about perceived limits to post-market control of 510(k) devices. Post market studies are not a requirement for 510(k) devices in the U.S and FDA has no officially explicit authority to withdraw 510(k) clearances. The non-requirement for 510(k) device manufacturers to notify the FDA of purchase, sale or transfer of 510(k) ownership also presents difficulties for the FDA in tracking post-market activities and adverse events.

The public meeting addressed these issues and more, with the program including a number of presentations by CDRH and speakers from the industry.   For a transcript of the meeting – and video files of the proceedings, click here.

US industry association Advamed responded by asserting that although there’s certainly room for improvement, the 510(k) process is essentially sound.  Advamed recently released a letter of recommendations in response to the FDA’s request for comments following the public meeting, in which many of the proposals and points raised at the meeting are echoed. The news release and letter can be viewed on the Advamed website here. 

Dramatic Slow Down in 510(k) reviews

Amongst all of this discussion of reform, recent experience shows a dramatic blow out in processing times for 510(k) reviews, with applications routinely going over the 90 day review target.  A combination of pressures for more thorough review, increase in applications and FDA’s recent relocation to White Oak have all slowed down reviews.  

Need help with applications to FDA?  In the current climate, strategy is vital. Consider your needs for pre-filing consultations and the possibility of third party assessment alternatives. Brandwood Biomedical has extensive experience of direct interactions with FDA to support 510(k), PMA and IDE reviews.  Contact us  to learn more.

Brandwood Biomedical is delighted to announce the opening of a new local office in Hong Kong. We’re very excited about this development, which gives us the capacity to better support our clients in achieving regulatory approval across Asia. The Office was launched in November in conjunction with the inaugural Hong Kong Medical Devices Fair and Asian Harmonisation Working Party Conference.  Read on below for an update on AHWP.  

This is the first of a number of Asian regional offices for the company.  By developing a strong presence in Asia, we also look forward to working more closely with regional contract manufacturers and OEMs.

Do you need help in finding, assessing and qualifying the right contract manufacturer, or do you need support for regulatory approval in Asia? Contact us to talk.

 Introducing DevDx Clinical 

Brandwood Biomedical is proud to introduce DevDx Clinical, a full-service CRO dedicated to clinical diagnostics and medical devices. The company is a joint venture between Brandwood Biomedical and Australia’s leading data management and biostatistics consultancy Emphron. The combined expertise from both firms covers all phases of device and diagnostic product development, giving DevDx the capability to manage complete clinical trial programs or specific projects, from regulatory and ethical submissions to data management and statistical analysis. We understand that device and IVD trials are markedly different from Pharma trials and call for very different approaches.  For most CROs, these trials are a small adjunct to their Pharma Portfolio -  at DevDx, devices and diagnostics are our core business.  Click here for detailed information.

AHWP meets in Hong Kong

Brandwood Biomedical Principal Arthur Brandwood attended the Asian Harmonisation Working Party conference in Hong Kong from 4-7 November.  This conference brought together industry leaders and regulators from 27 countries across Asia and now includes a number of jurisdictions in the Middle East, South America and South Africa.

The meeting was striking for the clear resolve to develop an independent and comprehensive approach to regulatory development  which builds on the efforts of the GHTF.  Membership of AHWP continues to expand – with most South American and middle Eastern jurisdictions along with Russia either already members or about to join.  AHWP already includes the large markets of China and India.  This raises the possibility of just two global harmonisation groups – the 5 member GHTF and AHWP which encompasses all other significant markets.  Given the obvious energy and commitment at AHWP, the question arises as to which will be the most significant in the longer term.  See the new AHWP website at www.AHWP.info for full details on the activities and workplans.

TGA looks to tighten regulation of joint replacement implants

The TGA has released a proposal for the re-classification of certain orthopaedic joint replacements from Class IIb to Class III. The proposal affects replacements of the hip, knee and shoulder including both total and partial replacement s, but excluding ancillary devices such as screws and wedges. The move has been made to strengthen Australian regulatory control by bringing the regulations in line with the European Medical Device Directive.  The EU implemented the re-classification of total joint replacements from Class IIb to Class III in 2005 with the transition period ending in September 2010. The move was triggered by a number of factors, including the rising population of younger active patients requiring joint replacements and the high rate of revision for such implants.

What does this possible change mean for manufacturers of these implants or those looking to market such implants in Australia? Under the proposed changes, manufacturers would be obligated to comply with the more stringent requirements of a Class III medical device. This involves additional regulatory documentation detailing the design of the device, manufacturing processes and the intended performance of the device.  Any changes to an approved design must be approved by the conformity assessment body before the changes can be implemented. The proposed change will certainly incur more expense and resources for the manufacturer, with Class III devices requiring tighter post-market monitoring, tracking and recall. Although the changes will increase the regulatory burden for manufacturers if implemented, they will ensure closer alignment with European regulation and GHTF recommendations, reducing the danger of potential risks being introduced into Australia.  

TGA is inviting comments and input from the industry for the proposal, which can be viewed here.

 Happy Holidays!

And so we come to the close of yet another year as we gear up for Christmas and the New Year. Brandwood Biomedical will be closing the office on the 24^th December and will be back in business on the 4^th January. We wish all of our clients and friends the most relaxing and happiest of holiday breaks and look forward to working together in a successful 2010.

The 2009 AusBiotech Conference is the premier event for the Asia Pacific biotechnology and life sciences industry. Brandwood Biomedical is proud to be supporting the event which will be held at the Melbourne Convention and Exhibition Centre from 27^th-30^th October.

The conference will feature a number of sessions and presentations with themes ranging from medical technology to investment and business, providing attendees with a great opportunity to learn about the latest technological developments and the new challenges they bring.

Brandwood Biomedical Managing Director, Arthur Brandwood will be speaking in the session titled “In Vitro Diagnostics: New Technologies, New Markets, New Regulations, New Risks?”,  to be held on Thursday 29th October from 2:00 to 3:30 pm. A full schedule for the conference can be found here.

Want to talk? We’ll be at the conference exhibition under the stand “Constellation BioConsulting”, where we would be delighted to meet you – or please contact us if you wish to arrange a specific meeting.  Please feel free to arrange a specific time to meet at the conference via the biopartnering.com website: www.biopartnering.com

Laboratory Managers Conference 2009

Brandwood Biomedical is a proud supporter of the 2009 Laboratory Manager Conference. The conference will be held at the Sebel and Citigate Hotel in Melbourne from November 9^th – 11^th, and will feature sessions related to various aspects of laboratory management including analytical testing, education, research, regulation and quality control. The event will provide attendees with a chance to learn about new strategies and tools used in laboratory management, and also provide the opportunity to build networks with a range of leading specialists in laboratory, research, scientific and technical management. Click here to learn more. 

AusMedTech 09

AusMedtech09 was a great success.  In a year where conferences have struggled with numbers, attendance hit a record high.   Run on the 14^th and 15^th of June, delegates were treated to two days of world-class speakers and workshops focused on the overall message of the conference: creating value and mapping out the global path to success.  It was clear from the excitement and talk in the room that Australia is well equipped to position themselves on the world stage as medical device and diagnostic innovators.  This theme was re-iterated by the Hon Jodi Mckay, Minister for Science and Medical Research, who made an address at the conference welcome.

The conference dinner, sponsored by Brandwood Biomedical, was a very successful occasion allowing delegates time to relax and network with colleagues and friends from the industry. Thank you to all the organizers, speakers and delegates on a spectacular conference and we look forward to AusMedTech in 2010.

ARCS 09 follow up

The ARCS 18th Annual Scientific Congress was held on the 1st – 3rd June 2009 at the Sydney Convention and Exhibition Centre.   Attendance was up 5% on last year and boasted a large range of sessions covering the latest developments in the therapeutic development arena.  This was the first time that Brandwood Biomedical attended this congress and it was a very worthy event. 

Cost Effective Quality with Q-Pulse

Inefficient and time-consuming processes!  Poor employee buy-in!  Missed opportunities to trend and capture all the data!  These are all symptoms of a disjointed quality system that could benefit from an integrated compliance management system. 

Brandwood Biomedical is Australia’s only accredited supplier of Q-Pulse by Gael software in the Life Sciences sector. As a testament to our industry reputation and knowledge of quality management systems, we have recently forged an exclusive (Value added reseller) partnership with Gael, the suppliers of Q Pulse in the life science sector.We believe that Q–Pulse is one of the most cost effective solutions available.  Q-Pulse is a scalable and easy to use system that covers key quality and regulatory functions such as Auditing, Document Control and Corrective actions.  It is also fully compliant with US “Part 11” requirements.

 We can configure an implementation that’s right for you.  Head to the “Our Services” page for more details on Q-Pulse or contact us if you would like to know more. 

Update on Imminent European MDD Changes

In May the EC released an interpretative document of Directive 2007/47/EC, providing clarification on certain issues within the Directive. The interpretive document can be found here, and the Directive here.

In September 2007, the European Commission released Directive 2007/47/EC, a document which amended both the Medical Devices Directive MDD 93/42/EEC and the Active Implantable Medical Devices Directive AIMDD 90/385/EEC.  The amendments are to apply from 21^st March 2010.  To refresh your memory, the major changes made by Directive 2007/47/EC can be viewed in our March 2008 Newsletter, under the heading European MDD Changes. The most significant change would undoubtedly be the requirement for clinical evidence to be documented in the Technical File for all medical devices, regardless of class.

The interpretative document acts as a guidance document to address questions relating to the implementation of Directive 2007/47/EC.  The document states that medical devices placed on the market or put into service after March 21st 2010 would need to comply with the new requirements made in Directive 2007/47/EC. As no transitional provisions have been given, we recommend implementing the amendments much earlier than March 21^st 2010.  Products brought to the market or put into service before this date may continue to be marketed, however the manufacturer must document that their Declaration of Conformity states conformance with the amendments.

The document also states that certification for EC marking will no longer be unlimited as of 21^st March 2010, but will have a maximum validity of 5 years. Devices to be placed on the market or put into service after 21^st March 2010 with unlimited certificates require to be reissued with limited validity certification before the 21^st March. Those devices already on the market or put into service do not require reissuing of certificates and may use the unlimited validity CE marking certification.

Need assistance with implementing the amendments? Contact us to talk.

Brandwood Biomedical is a proud sponsor of the upcoming 2009 AusMedtech National Medical Technology Conference, to be held on the 15th and 16th June in Sydney.  We would like to highlight some specific sessions being featured by this premier national event for medical devices and diagnostics.

A Comprehensive Approach to Clinical Evaluation

Brandwood Biomedical is the sponsor for this devices regulatory affairs session which focuses on an integrated approach to clinical trials that includes initial regulatory approval, cost effectiveness assessments to support reimbursement and market acceptance. Three first class speakers will present:

Dr Peter Havel, TUV SUD Japan Ltd will describe the recent revisions to the EC Medical Device Directives (MDD) which considerably strengthened the requirements for clinical evaluation of medical devices.

Dr Jonathan Sackier, President, Paradigm Shift Healthcare Consulting, will describe the current US reimbursement environment and the importance of well framed clinical studies to support reimbursement.

Dr Martin Devitt, Medical Director, Perficio Clinical & Regulatory was previously Medical Director at Cook and Chief Medical Officer for Devices at TGA. He brings a wealth of experience in designing clinical trials to support all of the phases of product development from initial regulatory approval through to market acceptance by the clinical users.

In Vitro Diagnostics

This dedicated session on IVDs will feature an update from TGA on implementation of the new regulations and takes a look at the challenges of getting IVDs to market, in particular asking the question “is the real value of IVDs in health economics truly recognized?”

Chair: Caroline Beasley, Engagement Manager in Commercial Effectiveness, IMS Health

Speakers:

Dr Rob Danby, Manager IVD, Biomedical Instruments & Devices

Dr Jenny Harry, Managing Director, Tyrian Diagnostics

Dr Andrew Campitelli, Manager Diagnostics, MiniFab

Want to talk? Just drop by our stand at the conference exhibition where we would be delighted to meet you – or please contact us if you wish to arrange a specific meeting.

The full program for the conference can be found here.

ARCS (Association of Regulatory and Clinical Scientists) 18th Annual Scientific Congress 2009

Brandwood Biomedical will be exhibiting at this premier event to be held at the Sydney Convention and Exhibition Centre, June 1st-3rd 2009.

The ARCS conference will address the most pressing regulatory issues facing manufacturers of therapeutic goods today, these include post market surveillance in the new Australian regulatory environment and manufacturing process changes for biotech products.  Visit the Brandwood Biomedical team at Booth Number 66 or contact us to arrange a specific meeting.

Click here for more information and to register.

New TGA IVD Regulatory Framework by years end

TGA is proceeding with implementation of the new regulatory framework for IVDs. This will bring about an end to the widespread current exemptions for regulation of IVDs with the introduction of a four tier classification system and co-regulatory arrangement with NATA for oversight of in-house tests offered by single laboratories. The regulations are in a broad sense on par with the European IVD framework terms, but of course, the devil is always in the detail. Visit our blog for more details a comparison between the two systems.

AdvaMed reveals proposal for improved U.S regulation of IVDs

US Industry association AdvaMed has set forth a proposal to the FDA to update the regulation of in vitro diagnostics (IVDs) and lab-developed tests (LDTs). The proposed risk-based strategy recommends applying the same regulations to all diagnostics, regardless of location of manufacture.

The proposal details a number of recommendations including:

data submission requirements for pre-market approval to be determined from the level of risk of a diagnostic






test for rare diseases or test used very rarely should not be subject to premarket submission, instead requiring more intense adherence to the Clinical lab Improvements Act (CLIA) and adverse event reporting






exemption of well standardised and low risk tests from premarket review

A risk-based tier system has also been proposed, to be used along with the existing classification system for IVDs, to determine the depth of pre-market review required for certain diagnostics. AdvaMed plan to submit a separate proposal for the necessary criteria of IVDs for exemption from pre-market submission requirements.

The proposal has been put together with continuous consultation with the FDA and further discussions are on the agenda. The proposal can be viewed here.

ASEAN on track with Harmonisation of Medical Device & IVD Regulations

The Association of Southeast Asian Nations (ASEAN) is making moves to harmonise medical device and IVD regulations in all its member states, which include Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam.

ASEAN is an organisation dedicated to advancing the economic development and competitiveness in South East Asia by developing a free trade area for local manufacturers and harmonising industry regulations, comparable to the set up in Europe with the European Community (EC).

Because healthcare integration remains a top priority for ASEAN, the Medical Device Product Working Group (MDPWG) was established in 2004 to develop a harmonised Medical Device and IVD regulatory framework for the ten ASEAN nations. This regulation is known as the ASEAN Medical Device Directive (AMDD) and is closely modelled on the Global Harmonisation Task Force (GHTF) recommendations. Although yet to be finalised, it is planned that the Directive will be implemented by most members by 2010 and in all member nations by 2015.

For medical device manufacturers, this means that regulation in the Southeast Asian market promises to become more closely aligned with the global GHTF model. On the one hand the process will be potentially simpler and streamlined, as product approval for all ASEAN countries can be obtained with a common submission dossier. However, the reality may be an increase in the level of regulation as the existing arrangements are upgraded to a comprehensive GHTF style regulation. Leading the way in ASEAN is Singapore, which is in the late stages of implementing a fully harmonised regulatory system. Singapore will require full conformity assessment of higher risk products with attendant substantial fees and projected 210 day review cycles.

Need advice on how to enter the Southeast Asian market? Contact us to discuss your needs.

Australian Third Party Assessment back on the Table...

At the end of last year, the TGA released a consultation paper on the use of Third Party Conformity Assessments for medical devices in Australia.

Currently, the TGA is the only Conformity Assessment Body for Australian manufacturers of medical devices. Industry has long been calling for the introduction of third party assessment for medical devices, a view echoed by the 2006 Australian Productivity Commission Banks Review. For detailed information on the benefits of third party assessment and international practices see this paper prepared for Ausbiotech as part of TGA consultations on 3^rd Party Assessment.

The consultation paper poses questions relating to the responsibilities and roles that should be given to the TGA as the medical device regulatory authority and to a third party assessor.  The paper outlines various factors that would need to be considered, including the class and material composition of the device. TGA are now seeking input on using third party assessment and what role they should have in the assessment and approval processes. Submissions are being accepted until Friday 27 March 2009. TGA is also holding free workshops open for all interested in voicing and sharing perspectives. These workshops are to be held on Tuesday 17^th March in Sydney and Wednesday 18^th March in Melbourne.

Click here to read the consultation paper and to submit your comments and input.

New TGA IVD Regulations to start this year

At the end of February, TGA published its proposed new regulations for In Vitro Diagnostic Devices (IVDs). These regulations follow the overall approach of the European IVD directive. However there are differences in the detailed classification rules and the regulations also include “in house” IVDs developed within a laboratory or laboratory network and are not supplied in a commercial context. TGA has teamed with NATA for the regulation of these “in house tests”

We will be publishing a more detailed review of the new regulations shortly. Meanwhile the following are key points to note.

• A new set of Australian classification rules which broadly follow the European approach but with some important differences in detail.


• A new national database for notification of “in house” tests to TGA. This will be combined with cross checking with NATA audits to confirm that pathology and hospital labs have notified tests to TGA and that NATA has certified all tests on the TGA database.


• The current proposal has TGA as the monopoly authority for regulation of Australian IVD manufacturers. This is of concern in context of current moves to introduce 3^rd Party assessment for medical devices in Australia.


• A total ban on any home use device intended to test for pathogens, notifiable diseases or serious disorders or determine genetic traits


• Clinical trial arrangements will be essentially as apply to medical devices.


• Postmarket “vigilance” arrangements will apply and a postmarket surveillance regime including TGA sampling and testing.

See the TGA consultation document here.

Significant Confusion over Significant Change

In all major jurisdictions, a significant change to a medical device design or to a manufacturing process triggers additional regulatory review. Identification of a significant change and when it’s necessary to notify a regulator can be perplexing at the very least. To complicate things, a change which is considered significant in one product may not be considered significant in another, due to differences in intended use, classification and other factors.

In general terms, a significant change is one which introduces a new design feature, intended purpose or production process and which alters the risk profile. Examples include:

• Any change to manufacturing process, facility or equipment used for the device, affecting the risk of the product. This includes any change to a “special” process which requires revallidation. For example, the addition of a new subcontractor for the “special process” of ethylene oxide sterilisation requires validation of the process and the subcontractor. On the other hand, a new supplier of straightforward components or materials with well defined specifications would not usually be considered a significant change.


• Some changes to manufacturing quality control procedures, including introduction of new methods for testing of quality and sterility of materials and the device.


• A significant design change can include a change in a component material of the product to improve performance which requires new clinical testing to confirm safety and efficacy of the product. A change in design for aesthetic reasons is not considered a significant change.


• Any changes to theintended use of the device, including new or additional uses, removal of uses or changes to shelf life.

Changes to a revised EU Medical Device Directive, which are to take effect in March 2010, include that even one significant change to a product after receipt of CE approval requires that product to undergo the approval process again. The European Notified Bodies association has released guidance for manufacturers, “Reporting of design changes and changes of the Quality System”. In Canada the manufacturer is required to have a procedure in place to identify a significant change and for amending a license in the event of a significant change for Class III or IV devices. Also available are a Canadian Guidance for the Interpretation of Significant Change and an FDA guidance to help with deciding when to submit a 510(k) for a change to an existing device. Still confused? Contact us for advice – we can advise you in determining if changes are significant and assist communications with regulators regarding the change.

Electronic Medical Devices to face harsher laws in Europe

For those marketing electronic medical devices in Europe, even more stringent laws may be faced in the near future.

The European Commission are currently drafting a revised Waste Electrical and Electronic Equipment (WEEE) Directive and Restriction of Hazardous Substances (ROHS) Directive to work towards meeting higher targets for the collection and recycling of waste electricals.

ROHS, introduced in July 2006, regulates the levels of hazardous substances in electrical and electronic products, while the WEEE Directive, first issued in June 2003, provides regulation for the treatment, recovery and recycling of electric and electronic equipment.

Before the revisions, medical devices and monitoring & control instruments were excluded from the scope of the ROHS Directive. The draft revision now covers both categories, so will apply to these products. In this context, medical devices include in vitro diagnostics, but not active implantable medical devices. Provisions for the inclusion of active implantable medical devices will be reviewed by 2020. The proposed revisions for the WEEE Directive include an annual waste collection target rate of 65% of the average amount of electrical and electronic equipment put on the market in the two preceding years.

Changes to both the ROHS and WEEE are in response to studies which have found less than half the electrical waste collected in the EU is subsequently treated and target levels are being increased to meet expectations in terms of protecting the environment and health.

and continuing on environmental matters...

Europe REACHing for Greener Solutions

Closely related to ROHS and WEEE is REACH, the Registration, Evaluation, Authorisation & Restriction of CHemical substances. REACH is a relatively new European regulation, introduced in June 2007 and addresses the management of risks associated with the production and use of chemical substances. The regulation aims to improve protection of human health and the environment against potentially harmful chemicals. REACH is also involved in promoting “green chemicals” and encourages manufacturers to work towards the gradual replacement of unsafe chemicals with safer, greener chemicals.

The regulation affects all manufacturers and importers of chemical substances, mixtures of chemical substances or chemical substances that make up an article. Medical devices affected by REACH range from dental filling materials and bone cements to catheters and pace makers. Any chemical substance used in a medical device which is not registered with the EU will need to go through an extensive registration process, requiring detailed technical data and results of testing for the safety of its use.

A number of REACH Annexes, which include technical guidances, are currently being reviewed. More information about REACH can be found on the European Chemicals Agency (ECHA) website.

Worried about compliance with European environmental regulations? Contact us for advice on how these changes may affect your business.

Are you in control of your suppliers...

This month the Global Harmonisation Task Force (GHTF) Study Group 3 released the final guidance on Control of Products and Services Obtained from Suppliers. The document is part of a series that cover quality management systems and describes the various controls that are to be exercised over the products and services of suppliers. The GHTF guidance details the responsibilities of the manufacturer to control its suppliers and vendors. Click here to view the GHTF document.

Manufacturer control over the supplier is addressed in Section 7.4.1 of ISO13485:2003 and Sec. 820.50 (a)(1) of 21CFR820, which require the manufacturer to exercise the right amount of control over the supplier based on the criticality and effect of the supplied product to the quality of the final product. By defining the risk associated with the supplied product, the correct level and type of control can be exercised. Multiple options exist, including vendor on site audits, incoming inspection processes, mandatory testing to your specifications at the supplier, and supplier certification.

At Brandwood Biomedical we can help you understand what methods of control are suitable for your needs and provide direct assistance with supplier controls, including conduct of on site vendor audits on your behalf. Contact us to discuss your needs.

Paul Cohen joins Brandwood Biomedical

Brandwood Biomedical is delighted to announce that Paul Cohen has joined us as Senior Consultant. Paul comes to us with a wealth of experience, including 15 years in the diagnostics industry, plus senior roles in pharmaceutical and medical device regulatory affairs. Paul has particular expertise in clinical trials management and in product development of high risk implantables. See Paul's full profile

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AusMedtech Conference 2009

Brandwood Biomedical is proud to be supporting the 2009 AusMedtech National Medical Technology Conference to be held in Sydney on 15th and 16th June. This is the premier national event for medical devices and diagnostics. The exciting and relevant programme provides many opportunities to learn and to network with industry colleagues. Some highlights include the latest developments on the new TGA IVD regulations and proposals for introduction of 3rd Party conformity assessment in Australia. Don’t miss the opportunities to build your strategies and networks for a successful business through the wealth of information and experience offered by some of the leading individuals and businesses of the international industry.

Want to talk? Just drop by our stand at the conference exhibition where we would be delighted to meet you – or please contact us if you wish to arrange a specific meeting.

On Wednesday 3rd December 2008 the Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 was introduced to the Senate. This bill is a mixture of some housekeeping measures, plus some widening of TGA’s ability to publish and share information about therapeutic goods.

The bill will:

• Provide for medical devices to be exempted in certain circumstances, as medicines are currently, from provisions in the Therapeutic Goods Act 1989. This will allow medical devices to be stockpiled to deal with possible emergencies or be made available quickly in the case of actual emergencies;


• Clarify the 'fit and proper person' test and ensure it is applied more effectively and directly to matters relevant to manufacturing therapeutic goods in Australia. In clarifying this test the TGA aims to reduce any unnecessary regulatory requirements;


• Adopt the European Pharmacopoeia or the United States Pharmacopoeia as additional default standards under the Act;


• Expand the range of therapeutic goods information that can be released to the public and provide a wider range of circumstances where the TGA can release information to Commonwealth agencies or international authorities to support safety and quality in therapeutic goods;


• Apply more consistency to the regulation of advertisements in all media that include restricted representations to apply requirements to both those that require pre-approval and those that don't.

The bill principally implements enhancements identified during the development of the Australia New Zealand Therapeutic Products Authority (ANZPTA) and is the first of a package of reforms. Further legislative amendments are to follow. This current Bill does not address the forthcoming introduction of In Vitro Diagnostics Regulations to align with international practice, particularly the European IVD Directive. That regulatory change is still being drafted and TGA hopes to introduce the regulations in the autumn sitting of Parliament.

Changes to documentation requirements for medical device application audit process

Despite these changes, further documentation may still be requested to clarify any concerns, especially for higher risk devices.  The normal documentary requirements for pre-market medical device application audits have been reduced by the TGA, effective from the 1st December 2008, as detailed in Guidance Document Number 2:Application Audits.  The changes have been implemented to reduce regulatory burdens for sponsors.  Changes include:

1. Only one copy of the documentary evidence for mandatory audits will need to be submitted to the TGA.


2. The following documentary evidence will not need to be routinely provided for a mandatory application audit:
   
   
   
   • Third party quality management system audit reports
   
   
   • Third party design examination or type examination audit reports
   
   
   • Essential principles checklist
   
   
   • Sterilisation process validation report
   
   
   
   

Despite these changes, further documentation may still be requested to clarify any concerns, especially for higher risk devices. Processing time will not consequently reduce as there will be a more focussed assessment of remaining primary sources of evidence such as clinical evidence, risk analysis and the manufacturer’s Declaration of Conformity to Australian requirements. Guidance Document Number 2: Application Audits is still currently undergoing review regarding broader changes. The current version of the document can be viewed here.

CDRH Learn – Online training from US FDA

FDA’s Center for Devices and Radiological Health (CDRH) has recently uploaded free e-courses on their website here. “CDRH Learn” offers information about medical device and radiological health regulation in the USA. The courses provide introductory information about requirements for medical devices, ideal for those who are looking to gain a basic overview of the regulatory environment for medical devices in the States.

A Challenging Economic Climate – The importance of doing it right the first time

The current financial crisis has led to a slow down of activity in the biotech and medical devices sector. As companies reassess their finances, expenditure and time constraints, they are realising that now more than ever, it is important to ‘do it right the first time’.

The product development and regulatory process is a much more dynamic situation than many companies are aware of or truly understand - quality systems and regulations are dimensions of a company that should interface throughout the entire process.

With issues involving new technologies, complexity of devices such as combination products, and changing regulations, seeking regulatory advice at the end of the process will result in substantial time and dollar costs. Hence is it vital to have the right tools in place to meet regulatory requirements and gain approval efficiently. This is an important step in ensuring the success of a product and sometimes even a business.

Don’t Forget the Reason for the Season

During these tough financial times some are finding it hard, but please spare a thought for those who are finding it even harder. At Brandwood Biomedical we support the dedicated efforts of World Vision and the Smith Family and we encourage you to do them same. Please visit World Vision and the Smith Family to make a real difference this festive season.

Brandwood Biomedical Closed for Christmas. See you in 2009!

Brandwood Biomedical will be closing the office from the 19^th of December for a well earned holiday. We will re-open on the 5^th of January. We wish you all a Happy Christmas and New Year and we’ll see you again soon!

Walking the Talk - Brandwood Biomedical Achieves ISO 9001

We are proud to announce that we have achieved AS ISO:9001 certification for our technical, regulatory and quality consultancy services. ISO certification demonstrates our commitment to professionalism and integrity as well as to consistently provide you with the highest quality service and advice. When selecting an advisor to advise you on quality or regulatory compliance – ask the question – what level of certification or compliance have they achieved for their own operations? Copies of our certification, quality policy and quality manual are available on our website.

Human Factors

The US FDA has recently highlighted the contribution of human factors to adverse events in medical devices. The pertinent issue is where does the responsibility lie in ensuring correct device usage? In answer to this question, we have to look at both sides of the fence. With the rapid development of new technologies and advancement of medical devices, users are not only faced with of increasing complexity, but a greater range and diversity of devices, all of which add to the problem of incorrect usage. Medical device manufacturers need to go back to Engineering-101 and deliver device interfaces that are appropriate to the user training and skill level. So, to answer the question, both the user and manufacturer have responsibilities, but the root problem of adverse events involving human factors is often poor user interface design. Designs should also accommodate considerations for the environment where the device will be used as well as user expectations for the device. Click here to see the FDA article.

All Change at TGA...

Big changes are afoot at TGA as the 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. Click here for a review of the TGA changes.

Careers at Brandwood Biomedical

Brandwood Biomedical is growing rapidly and we are currently recruiting for new positions. If you have a regulatory, quality or product development background and are excited by the prospect of contributing to the growth of a specialist advisor working with some of the most innovative companies in the industry please contact us for a confidential chat.