Brandwood Biomedical Newsletter May 2009

AusMedtech Conference 2009

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.