For actual Medical Device Manufacturers, the question posed in the title of this article may seem a little silly. Medical Device Manufacturers obviously know who monitors, regulates, and audits them, and who they have to answer to when something goes wrong. For the rest of us though? We are left scratching our heads a bit.
Medical devices aren’t really ”consumed” by humans, so it would seem they would be regulated by a different governmental body than food or pharmaceutical drugs. However, in the United States, that is not the case. Medical devices fall under the umbrella of the Food and Drug Administration (FDA).
But what about the other places on this planet we call home? Below we’ve outlined what organizations regulate the medical device industry in some other countries around the world. We’ve provided a brief overview of each organization, and their associated webpage where you can find more information.
1. Canada: The Food and Drugs Act - The Minister of Health – Health Canada
In 1920, the Food and Drugs Act was passed by the Parliament of Canada to help ensure the safety of food, drugs, cosmetics, and some therapeutic devices. Today, that act is still in existence (although it has been updated many times), and now has an annex dealing with Medical Device Regulations. In Canada, the Minister of Health has the power to enforce the Food and Drugs Act.
Website: www.hc-sc.gc.ca
2. England: Medicines and Healthcare Products Regulatory Agency – Department of Health
In England, the 2003 merger of the Medicines Control Agency and the Medical Devices Agency created the Medicines and Healthcare Products Regulatory Agency. This agency is tasked with making sure medicines and medical devices are safe and up to acceptable standards. One of this agency’s chief roles is in surveillance post product marketing, otherwise known as audits!
Website: www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
3. Australia: ARGMD – Therapeutic Goods Administration – Department of Health
The Australian Therapeutic Goods Administration carries out assessments and monitoring activities of medical devices in order to ensure their safety for consumers within the country. On their website they list safety recalls, public notices, and have separate portals for consumers and medical professionals.
Website: www.tga.gov.au
4. The World: The World Health Organization (WHO)
While the World Health Organization can only propose regulations and make recommendations, they are a huge player in the world of medical device regulations. The WHO recognizes that proper regulation and safety of medical device production and storage is important for their attainment of the Millennium Development Goals. Overall, the WHO is there for guidance for medical device manufacturers.
Website: www.who.int/medical_devices/
