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)
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Packaging Materials and Systems for Medical Devices which Are to Be Sterilized, General Requirements and Test Methods [superceded by ISO 11607]
