INTO THE INTERNET
Originally Published June 2000
The internet has profoundly changed the way standards get written and promulgated, making it much easier for developers around the world to collaborate, contribute, and comply. It's also become much simpler for RA/QA personnel to follow the latest working drafts, and even anticipate future releases. A wealth of national and international regulatory information is available on the Web—but only to those who know where to look. This article will present a quick tour of several sites that will be useful to anyone involved in medical device regulatory affairs and quality control.
One particularly useful commercial site is that of RA Info, found at http://www.rainfo.org. The site doesn't actually offer any content on its own—just links to other sources. So, for example, visitors will find FDA enforcement reports and approval notices, a lengthy list of international regulatory resources, a directory of regulatory consultants, Federal Register notices, and job postings. Readers can also sign up for a monthly e-mailed newsletter covering regulatory developments around the world.
Information seekers would also do well to visit the Web sites of trade groups and professional societies that act as advocates for the medical device industry—such as Regulatory Affairs Professional Society (RAPS), Medical Device Manufacturers (MDMA), and Health Industry Manufacturer's Association (HIMA). These groups should be familiar already. Generally, they require a membership fee, but provide public access to some important information on their sites. Usually, members get access to information that nonmembers do not.
The RAPS site, for example, can be found at http://www.raps.org. Of chief interest here is the "Information and Research" section, where visitors will find RA catalogs, forms, research tools, job postings, member directories, and discussion groups, as well as a link to the group's monthly magazine, RA Focus. Within the "Research Tools" subsection, users will find the "Reference Desk" and "Regulatory Links." The former is for quick answers to simple questions, while the latter is for more-detailed investigation of various regulations and regulatory agencies. The list of regulatory links is fairly extensive. In particular, users will find links to the major regulatory bodies of governments around the world and organizations ranging from HIMA to the British Institute of Regulatory Affairs, many of which will be covered in this article. Details of the RAPS certification program for regulatory professionals can also be found on the site.
HIMA maintains a site at http://www.himanet.com. Most MD&DI readers are already familiar with HIMA, a trade group that lobbies in Washington on behalf of large medical device manufacturers. Its site's "Industry Resources" section provides some general background about the industry, a calendar of upcoming events, relevant links, a list of industry acronyms, and some frequently asked questions, or FAQs; the latter are often very useful, and it's a good idea in general to read through them whenever they appear. HIMA's monthly newsletter is also posted, but many of the articles are only available to members. (Editor's note: HIMA has recently changed its name to AdvaMed, and will maintain a new site at http://www.advamed.org).
Representing the interests of small device companies, MDMA has a site at http://www.medicaldevices.org. The site's "News" section showcases the MDMA newsletter as well as a list of press statements. The site also has a select list of industry links, most of which will be useful to RA professionals. Like HIMA, MDMA is a lobbying group, so in addition to links to industry organizations, market research firms, and the like, visitors will find links to government agencies such as the Health Care Financing Administration.
Another familiar group, the Association for the Advancement of Medical Instrumentation (AAMI), has a site at http://www.aami.org. AAMI is perhaps most famous for its standards-writing activities, details of which can be found by following the link marked "Standards." Members can also view public release drafts and technical committee reports here. The "GMP/QS" link pulls up information about AAMI-sponsored courses, conferences, and publications. Information about AAMI's GMP Requirements and Industry Practice seminars can be found here, for example. Other documents relating to FDA compliance include human factors analysis and design control guidelines. The site editors also post occasional news items on the front page.
Equally useful is the FDLI site at http://www.fdli.org. Unlike HIMA and MDMA, FDLI is not a lobbying group, but something more of an information and education group, keeping track of regulatory developments and training personnel in regulatory affairs. FDLI runs a number of conferences, and news about upcoming seminars is usually posted on its site's front page. Going into the site further, one comes to the "Info Gateway," which holds a list of lawyers and consultants active in the industry, along with another list of industry acronyms, links to government agencies, and other regulatory resources. Items of interest here include legal information repositories from various universities across the country.
After the United States, Europe is the second-largest market for medical technology and a common launching point for American companies planning to expand overseas. Regulatory approval can often be obtained faster in Europe than in the United States—but that doesn't mean the regulatory arena is easier to navigate. A number of official European Union (EU) Web sites exist, but these are not always as helpful as one might wish. Some have too much information, others are confusing. Moreover, with every site sporting the official EU logo—a circle of stars on a blue background—it can be difficult to tell where one site ends and another begins.
For example, the main EU site is Europa, found at http://europa.eu.int/. Browsing through this site could easily take hours or even days. Visitors can learn all about the Council, the various ministries, the economic and social committee, the European ombudsman, and a host of other bureaucratic offices. But anyone looking for a particular document or subject should go straight to the search page and look for it there. If it doesn't show up, try a different site. The time savings will be significant. For instance, a search for the Medical Devices Directive did find the text of the directive—but a user would be hard pressed to track it down by simply following the site links.
Intimately affiliated with Europa is the site of the European Office of Publications (Eur-OP), located at http://eur-op.eu.int/. Official EU publications are available for sale, and this site is where they can be purchased. Official notices and acts of law get written into the Official Journal, which is somewhat akin to the U.S. Federal Register. Notices get archived on the EurLex database for 45 days, after which they can be purchased through EUDOR, the EU Document Repository. As mentioned, the Eur-OP site is tied to the main Europa site, and yet a search for the Medical Devices Directive produced no results.
The EUDOR site, which can be found at http://www.eudor.com/, is another place to order EU documents, if they're not available for free. Like the Eur-OP site, this site has an option to search the Official Journal. In this case, a search for the Medical Devices Directive did in fact produce a reference to the directive, with instructions for ordering it.
A more user-friendly site, "The European Union in the US," can be found at http://www.eurunion.org/. This site covers far more than just regulatory affairs. It's geared toward Americans looking to export products into the EU. Under the heading of "Help," for example, visitors will find the site search engine and a helpful list of FAQs, including questions related to customs, standards, intellectual property, and terminology. Here is where visitors can learn, for example, the answer to the question, "How do I comply with the CE mark requirements for my product when I export to the EU?"
Some of the most useful EU sites are not affiliated with the European Commission per se. A good example is DIMDI, a German site hosted at http://www.dimdi.de/engl/mpgengl/fr-mpge.htm. Obviously, the site is geared toward the German market, but much of the information applies to the entire EU market. The site provides information about EUDAMED, the German medical device information and classification system. Of most interest is the complete list of competent authorities and notified bodies; most manufacturers will have to contract with a notified body at some point to gain market clearance in Europe.
Also in Germany is a company known as the Medical Device Safety Service (MDSS), which has a site at http://www.mdss.com/welcome.htm. Though not sponsored by a government body or a trade group, this site carries more straightforward information than most official sites. Right on the front page, for example, are details about the In Vitro Diagnostics Directive and the Medical Devices Directive, including quick overviews, news, relevant links, and related details. Under "News and Information," visitors will find the list of notified bodies reprinted from the DIMDI site, as well as details about labeling and other issues. Again, most of this information is geared toward Americans, because MDSS is hoping to attract business as a designated representative for non-European firms. Under "EU Directives," users will find a number of very useful items—including the actual text of the Medical Devices Directive, available for download as a zipped file, and a list of checklists of the essential requirements.
Also noteworthy is the site of the European Confederation of Medical Devices Associations (EUCOMED)—a European counterpart to HIMA, although its scope may be broader. The site can be found at http://www.eucomed.be/. Under the "Current Issues" heading, visitors will find press releases. The "Focus Groups" section gives information about separate committees pursuing standardization in areas ranging from legal and regulatory to funding and reimbursement.
Across the channel is the Medical Devices Agency, the U.K. counterpart to FDA. Its site, located at http://www.medical-devices.gov.uk/, has a lot of useful information—although the arrangement is not altogether intuitive. For example, if users want to find information about the Medical Devices Directive in the A–Z index, they won't find it under M, for medical, but under R, for regulatory guidance. Once there, however, users will find all manner of guidance documents and related publications—including some guidance on understanding and complying with the directive.
Also worth a mention is the Irish Medical Device Association's site, which can be found at http://www.ireland.org/imda/. The site doesn't get updated very often, but what information is there looks as though it might be useful, and the organization itself might be able to help companies track down standards and regulations specific to Ireland.
OTHER INTERNATIONAL SITES
Though Europe is still the largest market outside the United States, it's not the only one that's been attracting device firms. Fortunately, many other countries follow the lead of Europe or the United States in setting regulatory policies.
Canada, for example, can be seen as a bridge between the United States and the EU. Health Canada is essentially the information branch of the Canadian Ministry of Health, the counterpart to the U.S. FDA. The group has a site at http://www.hc-sc.gc.ca/. On either side of the main page are lists of some of the issues affecting the Canadian market. Following the "Regulation and Policy" link in the top navigation bar, one comes to a list of public health acts. Of particular interest is the Food and Drugs Act, which governs medical devices. Scrolling down the page, one also finds a list of medical device guidance documents, information on Canada's healthcare initiatives, and similar documents.
Medical Devices Canada is the Canadian equivalent of HIMA or MDMA. Its site, which is located at http://www.medec.org/, carries information about the Canadian regulatory environment, told from the manufacturer's perspective. Here, too, can be found information about what a company needs to do to enter the Canadian market.
Another English-speaking part of the world—Australia—offers an important market for manufacturers looking to expand overseas. The Therapeutic Goods Administration, which has a site at http://www.health.gov.au/tga/, is Australia's counterpart to FDA. Under the heading "Medical Devices" can be found some very specific information about Australian regulation of medical devices. In general, the country's policy conforms to EU policy. Australia is also confronting many of the issues—ranging from cost containment to device reprocessing— that are affecting markets in the United States.
In Japan, which is probably the third-largest market for medical technology after the United States and the EU, the Ministry of Health and Welfare is the regulatory body. Its official English-language site, at http://www.mhw.go.jp/english/index.html, does not look very official, nor does it carry much information in English, but visitors will find a decent overview of the healthcare system and market.
A final international site is that of the Global Harmonization Task Force at http://www.ghtf.org/. The GHTF was founded by the United States, EU, Canada, Japan, and Australia. Each of the task force's study groups has its own section on the site—SG1 deals with regulatory systems, SG2 focuses on postmarket surveillance, SG3 deals with quality systems, and SG4 handles quality system audits. Each group posts working drafts of documents and other items for discussion and comment.
As for the U.S. regulatory system, most manufacturers have probably already visited the CDRH site at http://www.fda.gov/cdrh. Many, however, may be unaware of the site's electronic reading room, found at http://www.fda.gov/foi/electrr.htm. All of the most requested FDA documents are available there.
Also of interest are the Federal Register site at http://www.access.gpo.gov/su_docs/aces/aces140.html and http://www.access.gpo.gov/nara/cfr/cfr-table-search.html, which covers the code of Federal Regulations. There's also http://thomas.loc.gov/, maintained by the Library of Congress, where researchers can check the status of bills making their way through the House and Senate.
A number of helpful sites focus more specifically on QA/QC. Perhaps the most notable is the American Society for Quality (ASQ) site, at http://www.asq.org/. The site has some very handy primers on ISO and other QA protocols. The society also conducts seminars and workshops, has a certification program for QA/QC professionals, and takes part in the standards-making process. For example, it is involved in ISO/TC 176 on quality management and ISO/TC 69 on terminology and symbols. The site's "Standards FAQs" is a very useful reference, and the "Research and Information" section provides tips for conducting research into QA/QC matters.
Another reference specifically on the ISO series of standards is ISO Easy, which has a site at http://www.isoeasy.org/. One of the best places to start is by browsing through the FAQs, which cover everything from how to choose which standard to follow to how to meet the actual requirements. Like many of the sites mentioned so far, the ISO Easy site gives extra information to its members, an example of which is a discussion of the 20 elements of ISO 9000. Visitors will also find each of the four major elements of the ISO 9000:2000 revisions clearly laid out.
STANDARDS AND COMPLIANCE
Two more sites focusing on standards and compliance deserve mention. The first is that of National Standards Systems Network found at http://www.nssn.org/. One of the main draws there is the STAR program, the standards tracking and reporting service. Subscribers indicate which standards they're interested in, and receive automatic notification via e-mail whenever those standards are updated, modified, or scheduled for revisions. Also on the site, under the heading of "Information Resources," are federal government links, ISO updates, and information about other standards-related activities.
Last up is the Regulatory Compliance Information Center site at http://www.rcic.com/. It's not specific to the medical device industry, but it certainly covers it. Here, visitors can find compliance-related jobs, colleagues in the field, compliance-related software, and compliance-related news. But the main draw is the "Cyber Compliance Search Engine," which is keyed to search only compliance and regulatory sites. Visitors can use it to perform a quick search, or jump to the "Regulations and Standards" section, which is a prekeyed search for international regulations and standards. Also under the "Regulations and Standards" heading is a list of some pertinent standards from around the world— including, for example, the text of the EU–U.S. mutual recognition agreement.
As a reminder, links to all these sites can be found on Medical DeviceLink. Clearly, they carry much more information than can be described in this article, and readers would do well to familiarize themselves with at least some of these sites. Spending a few minutes when time is not scarce can save a lot of time when it is.
Gabriel Spera is editor of Medical DeviceLink.
Illustration by Garry Nichols/The Stock Illustration Source
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