Consensus Statement on the Future of Medical Device Registries outlines comprehensive guidelines for the implementation of registries across Asia-Pacific & Middle East- North Africa
Singapore, 6th February 2017 – The Asia Pacific Medical Technology Association (APACMed), the Medical Technology Association of Australia (MTAA) and Mecomed (Medical Technology Association Middle East and North Africa) announced today the release of a Consensus Statement on the Future of Medical Device Registries.
Medical device registries enable longitudinal tracking of patient outcomes and device performance serving as a compelling tool in providing real-world data. “This landmark paper characterises current region-specific gaps across three continents and provides recommendations for the responsible development, implementation, and maintenance of a medical device registry. Establishing credible data metrics is essential to facilitate safe, appropriate therapy access for our patients. To that end, we anticipate this document will serve as a reference standard for providers, payers, patients, policy makers, and other interested stakeholders”, said Dr. Amit Shanker, Chair of the APACMed Medical and Clinical Affairs Committee and Boston Scientific CMO for Asia-Pacific/Middle East/Africa.
However, there remain significant barriers to initiate a new registry across Asia-Pacific and MENA, ranging from the scarcity of qualified, dedicated staff to the lack of data warehouses and analytical centres. “Whilst local hospitals and governments may be willing to invest in medical device registries, ongoing commercial support may be necessary to collaboratively build these capabilities”, explained Val Theisz, Director of Regulatory Affairs, of the MTAA. “This presents us with a unique opportunity to strengthen public – private collaborative partnerships”.
Commenting on the guiding principles set out in the statement, and echoing the need for collaboration Nurgul Vatansever, Director, Strategy & Operations, Johnson & Johnson Middle East and Head of Market Access Focus Group at Mecomed, commented: “Our intention is to provide a blueprint for medical devices registries in the region. While most of the technology for managing a registry already exists, the complexity lies in establishing appropriate governance and transparent funding, as well as determining what we want to measure, and how we can collect, access and report quality data. This will require input from across the healthcare ecosystem”.
Notes to Editors:
Founded in 2014, the Asia Pacific Medical Technology Association (APACMed) is the first and only regional association to provide a unified voice for the medical technology industry in Asia Pacific. APACMed works proactively with bilateral, regional and local government bodies to shape policies, demonstrate the value of innovation and promote regulatory harmonization. APACMed engages with medical device associations and companies in Asia Pacific to jointly advance regional issues such as access, innovation and collaboration to improve standards of care for patients.
The report was initiated by the APACMed Medical/ Clinical Affairs Committee.
The Medical Technology Association of Australia (MTAA) is the national association representing companies in the medical technology industry. MTAA aims to ensure the benefits of modern, innovative and reliable medical technology are delivered effectively to provide better health outcomes to the Australian community.
Established in 2007, MECOMED is the medical devices, imaging and diagnostics trade association; serving as the voice of international medical technology manufacturers (MedTech) for 21 countries across the Middle East and North Africa. MECOMED spearheads initiatives to work closely with healthcare officials in the MENA countries. Thus, the organisation coordinates efforts helping set credible healthcare standards for the region. In addition to that, Mecomed puts the core competencies of its constituent members to formulate, evolve and sustain ethical business practices.
Emilie Rapley Mills
Asia Pacific Medical Technology Association (APACMed)
Government Relations and Communications Manager
Medical Technology Association of Australia (MTAA)
Dr. Inna Nadelwais
Medical Technology Association Middle East & North Africa
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