International Bodies
Global Medical Technology Alliance
The Global Medical Technology Alliance (GMTA) is a group of national and/or regional associations whose members’ missions are to provide safe, effective and innovative medical technology that saves and enhances lives, benefiting people and society. The Alliance provides a forum where members can exchange information and work together to develop and advocate policies that encourage innovation to address patients’ healthcare needs.
The Alliance objectives include:
- Developing and disseminating information on policies and issues impacting medical technology on a global basis
- Coordinating common industry positions for effective representation at a global level in forums such as the World Health Organization (WHO), World Bank (WB), World Intellectual Property Organization (WIPO), and World Trade Organization (WTO)
- Encouraging an international policy environment that supports the development of the medical technology industry
- Liaising with other international bodies such as patients’ organisations and professional societies
The membership of the Alliance is made up of:
- National and regional medical technology associations
- Sectoral associations from the same national or regional area (e.g. devices, imaging, diagnostics)
- Associate or affiliate membership of entities that are not within the primary group of members but support the industry (e.g. GS1 Healthcare, an organisation promoting global standards)
Global Harmonization Task Force
The Global Harmonization Task Force (GHTF) was set up in 1992 to address a growing need for international harmonisation in the regulation of medical devices. The GHTF is a voluntary group, with representatives from national regulatory authorities and the regulated industry. It is grouped into three geographical areas: Europe, Asia-Pacific and North America, each of which actively regulates medical devices using their own unique regulatory framework.
The purpose of the GHTF is threefold:
- To encourage convergence in regulatory practices related to ensuring the safety, effectiveness / performance and quality of medical devices
- To promote ethical and compliant business practices
- To promote innovation
- To facilitate international trade
It does this by regularly publishing and disseminating harmonised guidance documents on basic regulatory practices. These documents, developed by five different GHTF Study Groups, provide a model for the regulation of medical devices that can then be adopted or implemented by national regulatory authorities.
The GHTF also serves as an information exchange forum through which countries with medical device regulatory systems can share experiences.
Early October 2011, representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan and United States, as well as the World Health Organisation (WHO), met to address the establishment and operation of a new organisation, the International Medical Device Regulators' Forum (IMDRF). In time, the IMDRF will replace the GHTF.
This Forum is set-up to accelerate international medical device regulatory harmonisation. The Forum's Management Committee, composed of regulatory officials, will provide guidance on strategies, policies, directions, membership and activities. Furthermore the Management Committee will oversee Ad Hoc Working Groups which may draw upon expertise from various stakeholder groups such as industry, academia, healthcare professionals, and consumer and patient groups.
The IMDRF will meet bi-annually with the inaugural meeting taking place in Singapore from 28 February to 1 March 2012 under the leadership of Australia. As part of these bi-annual meetings stakeholders will have an opportunity to learn of the work of the Forum, provide input on emerging issues and suggest potential new work items.
The IMDRF will initially exist in parallel with the GHTF until the work of the GHTF is wrapped up and/or transferred to the new body.
More information: www.ghtf.org
European Union Chamber of Commerce in China
The European Union Chamber of Commerce in China (EUCCC) was founded in October 2000 by 51 member companies based in China to help provide a common voice for the EU and European businesses. Now with 1,400 member companies and seven offices, the EUCCC provides European business with effective communication and lobbying channels to European and Chinese authorities, business associations and media.
There is a specific Healthcare Equipment (HCE) working group within the EUCCC, made up of more than 50 leading European and American medical technology companies, dedicated to bringing the latest medical technology and equipment to patients in China. At the same time, the members invest in the local market, by establishing modern Chinese research and production facilities, and by training healthcare professionals in how to maximise the benefits from medical technology.
In 2007, the two major European industry organisations for medical technology, Eucomed and COCIR (the European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry), set up their offices within the HCE working group. Under the banner of EUCCC-COCIR-Eucomed, the HCE Working Group carries out the following work:
- Creating a forum for healthcare equipment manufacturers to exchange views on and assess regulations relevant to their products
- Engaging in constructive dialogues with relevant local and national government authorities in China
- Promoting communication between Chinese and European medical technology industries by participating in projects and events organised by the EU in China
Each year, the HCE Working Group publishes its annual position paper, with its concerns and recommendations on trade, regulatory and broader policy-related issues. For 2010 -11, the main issues include:
- Establishing a single supervisory and administrative authority for medical devices, and to harmonise regulatory system with international systems
- Streamline pre-market approval processes for classification, standardisation and clinical trials
- Establish a complete and unbiased post-market surveillance regulatory framework
- Enhance government cooperation and communication with enterprises
- Seek fair competition to determine pricing, and continue to improve tendering processes
More information: http://www.europeanchamber.com.cn/view/home
Other initiatives
Eucomed also participates in other initiatives, including: