International Sites of Interest
to Medical Device Manufacturers
Australia/Pacific Rim
Australian Health Online is
a directory of Australian healthcare companies, hospitals, associations, and
other relevant organisations. The site requires you to register (free of charge)
before you can access any of the databases. There appears to be a significant
amount of useful information, but the site is is not particularly intuitive.
The Medical Industry Association
of Australia (MIAA) represents manufacturers, importers, and distributors
of medical devices and medical diagnostic products. The association serves as
the Australian link in global regulatory and standards harmonization, and it
maintains strong ties with its counterparts in North America, Europe, Japan,
and New Zealand. It provides education and information on matters that affect
the industry and offers networking opportunities to members with common interests.
It acts as an industry advocate with regard to technical and regulatory issues
and works with government and professional bodies.
The Therapeutic Goods
Administration is essentially Australia's counterpart to FDA. This site
offers much detailed information about the regulation of medical devices in
Australia.
The British Columbia Medical
Device Industry Association (BCMeDIA) facilitates education and R&D
related to the medical device industry in British Columbia. Members include
medical and assistive device manufacturers, pharmaceutical manufacturers, government
liaisons, educational institutions, consulting firms, laboratories, healthcare
facility operators, and students.
The Canadian Health Network.
Recently revamped, the Web site of the Canadian Health Ministry offers information
on programs and procedures as well as links to Canadian medical resources.
The Canadian Standards Association
is a not-for-profit membership-based association helping business, industry,
government, and consumers in Canada and the global marketplace to develop standards.
Medical Devices Canada (MEDEC)
is a trade association representing medical device companies in Canada. Established
in 1973, the nonprofit trade association has over 125 members representing manufacturers
and distributors of medical devices in Canada. MEDEC has three action groups
focused on regulatory, marketing, and professional development issues, and four
sector groups: cardiovascular, diagnostic, orthopedic, and ophthalmic. The group's
site features information on Canadian regulatory issues as well as recent news
releases, newsletters, and publications. The site also lists job postings and
links to other international regulatory agencies and trade groups.
European Union
The Association of British
Health-Care Industries (ABHI) is a U.K. trade association for the medical
device and systems industries. Members include manufacturers, distributors,
and associated service companies.
CORDIS (community research
and development information service) provides information about R&D sponsored
and supported by the EU. The site holds several discreet databases centered
on research news, opportunities, projects, study results, partners, publications,
contacts, acronyms, and documents.
DIMDI,
a branch of the German Federal Ministry of Health, compiles life-science databases
and maintains the official German versions of classifications and nomenclatures.
Highlights of the site include a directory of European Notified Bodies for the
Medical Device Directive. Click on the link marked EUDAMED in the left-hand
navigation bar to find it.
The EC office in the United
States sponsors a very large and useful Web site with information on news,
publications, organizations, international agreements, legislation, member states,
and more. Much of the information mirrors that found on Europa, slightly skewed
toward the U.S. perspective.
EUCOMED, the European
Confederation of Medical Devices Associations, is is the largest trade association
representing the medical device industry in Europe. Members include European
manufacturers and distributors of medical devices and accessories (excluding
in vitro diagnostic devices, active capital equipment, and optical and emergency
equipment) plus national device associations in 19 Euorpean countries and pan-European
product associations.
The site is probably the most important resource for European device manufacturers.
Membership is open to both companies and trade associations. The site contains
an organizational overview, a calendar of events, position papers, a weekly
journal, discussions of current issues, a membership roster, and a list of focus
groups. The full text of the Medical Device Directive can also be found here.
CELEX
is a bibliographic database and document-retrieval service. The site offers
easy public access to official EC communications, serving as a kind of electronic
archive for the two most requested EU publicationsthe "L" and "C" series
of the Official Journal of the European Communities.
Europa is managed by the
European Commission itself and provides current information on the objectives,
institutions, and policies of the EU. The site serves as an umbrella platform,
containing home pages for all the EC institutions, their individual components,
and specialized agencies as well as links to other servers.
European Committee for Standardization
(CEN) membership consists of standards institutions of the European Union
and the nations of the European Free Trade Association and the Czech Republic.
Standards are adopted by qualified majority voting and must be implemented by
the European standards bodies. They are voluntary in application. Many support
EU policies (e.g., CE marking for new-approach directives).
The European Diagnostic Manufacturers
Association (EDMA) is a nonprofit confederation of diagnostic manufacturers
and national associations representing the in vitro diagnostics industry at
the European level.
The European Medical Device
Distributors Alliance seeks to connect distributors in Europe with device
manufacturers around the globe. The site is not updated very frequently, but
does carry industry news and conference information. Follow the link marked
"About EMDDA" for a thorough introduction to the group and its activities, including
a list of members and guidelines for collaboration.
European Patent Office
documents European Patent Office applications in their original language plus
Japanese (PAJ) and other worldwide patent documents.
The National
Standards Authority of Ireland continuously supports enterprise, trade and
consumers through the provision of services of the highest quality in the areas
of Standards Development, Legal Metrology and Agrément; and provides
Certification Services globally in line with best international practice.
The Irish
Medical Devices Association is an organization formed to represent the position
of the medical devices industry in Ireland. Recently revamped, the site includes
an informative monthly newsletter detailing developments in the Irish and European
medical device industry.
The Medical Devices
Agency (U.K.) is Britain's counterpart to FDA's CDRH. The main page connects
to a comprehensive A-to-Z listing of subjects pertaining to the manufacture,
approval, monitoring, and marketing of medical devices. The list is not searchable,
unfortunately, so users might have to fish around for a particular piece of
data. The GHTF will be chaired this year by CDRH.
The Scottish Enterprise
is an network formed to strengthen the economic and technological progression
of Scotland through an online, interactive network. Recently established, this
network is based in Glasgow with 13 regional offices across Scotland. This site
includes a wide variety of services as well as guidance regarding R&D, e-commerce,
software, and small business development. Information is also provided on industry
clusters and local enterprise companies.
The Web site for Medical Devices in Scotland offers a variety of resources related to the medical
device industry in Scotland. The site has four main parts, including a search
assistant, which includes a database of companies, links, and services, and
an online library, which contains a bookstore, regulatory information, a glossary,
and journal links. The Scottish and global community sections offer information
relevant to the Scottish and worldwide medical devices industry.
The medical technology section of the European Federation of Precision, Mechanical,
and Optical Industries, Snitem
is also a member of EUCOMED and COCIR.
Global
The Web site of the Global Harmonization
Task Force primarily provides information about the group's next meeting,
but also has directories and information about individual task forces and study
groups.
An organization creating international standards for the electrical and electronic
industries, the International Electrotechnical
Commission (IEC) has developed a series of standards specifically for electromedical
equipment. Standards can enable electrical and electronic equipment to work
together no matter where it is designed, manufactured, assembled, or used. The
membership consists of more than 50 participating countries.
The International Organization
for Standardization (ISO) is a worldwide federation of national standards
bodies from some 130 countries that promotes the development of standardization
and related activities to facilitate the international exchange of goods and
services and to develop intellectual, scientific, technological, and economic
cooperation. ISOs technical committees, working groups, and ad hoc study
groups represent the viewpoints of manufacturers, vendors and users, engineering
professions, testing laboratories, public services, governments, consumer groups,
and research organizations in each member country.
SPE Scandinavia is a worldwide
professional association of 34,000 members is involved in the design, engineering,
R&D, processing, and production of plastics. The organization sponsors two
annual European conferences and exhibitions, Pharmaceutical and Medical Packaging
in May and Medical Plastics in September.

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