Regulatory Agencies Medical Packaging Pros Should Know

The following websites of regulatory agencies offer a wealth of information and guidance, as well as contacts and additional resources, to help stakeholders navigate laws pertaining to their medical devices and packaging. In addition to the Food and Drug Administration (FDA), the list includes international agencies in Australia, Europe, the United Kingdom, Japan, Korea, Singapore, and Turkey.

Involved regulatory agencies for packaging of medical devices or combination products are:

US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER)

US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH)

US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER)

US Department of Transportation

Australia’s Therapeutic Goods Administration (TGA)

Health Canada

European Union’s Medical Device Regulations (MDR)

EU MDR on in vitro diagnostic medical devices

European Chemicals Agency (ECHA)

International Medical Device Regulators Forum (IMDRF)

Japan’s Pharmaceuticals and Medical Devices Agency

Korean Ministry of Food and Drug Safety (MFDS)

Singapore’s Health Sciences Authority

Turkish Medicines and Medical Devices Agency

United Kingdom’s Medicines and Healthcare products Regulatory Agency