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Packaging Regulations for Medical Devices

Here’s a quick-click guide to essential US and international laws governing the design, development, and distribution of medical devices.

Kassandra Kania

March 2, 2023

1 Min Read
yavdat / iStock / Getty Images Plus

Staying up to date with the latest global regulations for medical device packaging is a monumental task at the best of times. To ensure the safety and efficacy of their products and conform to end user needs, medical device manufacturers must adhere to rules on the design and development of their packaging — covering everything from quality control systems to labeling and traceability.

To help you identify the laws you need to comply with, here is a list of packaging regulations for medical devices.


USA Regulations for Medical Device Packaging.

Food, Drug, and Cosmetics Act (FDC Act)

21 CFR 820 Quality System Regulation

21 CFR 820.30, Design Controls

21 CFR Part 803 Medical Device Reporting (MDR)

The Fair Packaging and Labeling Act

Safe Medical Devices Act (SMDA)

FDA Modernization Act

Unique Device Identification System (final rule)

21st Century Cures Act (Cures Act)


International regulations for Medical Device Packaging.

European Medical Device Directives

Medical Device Regulations (MDR)

EU MDR on In Vitro Diagnostic Medical Devices

European Packaging and Packaging Waste Directive

Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)

EN 868 Part 1: Packaging Materials and Systems for Medical Devices which Are to Be Sterilized, General Requirements and Test Methods [superceded by ISO 11607]

GHTF/SG1/N43:2005 Labelling for Medical Devices

Pharmaceuticals and Medical Devices Act (PMD Act) [Japan]

About the Author(s)

Kassandra Kania

Freelance Writer

Kassandra Kania is a freelance writer based in Charlotte, NC. She has written extensively about healthcare packaging for a variety of publications.

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