International Sites of Interest to Medical Device Manufacturers

 

Australia/Pacific Rim

 

AusMedtech is a state-supported directory of medical device and diagnostic companies operating in Victoria, Australia. Companies are sorted both alphabetically and by industry sector.

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.

 

Canada

 

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 publications—the "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. ISO’s 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.