Medical Device Labeling Requirements

Manufacturers both domestic and foreign and initial distributors importers of medical.

Medical device labeling requirements.

General device labeling 21 cfr part 801 use of symbols. Essential principle 13 of schedule 1 of the therapeutic goods medical devices regulations 2002 the regulations outlines the requirements for information that must be provided with a medical device including labelling and instructions for use. In iec 60601 1 labeling is deemed a critical component of a medical device 1 the standard provides comprehensive requirements for medical device marking and labeling. The actual definition of medical device labeling and the content of the labeling may vary and is defined in specific regional state or country specific regulations e g.

To assist manufacturers of non in vitro diagnostic devices in complying with the labelling requirements under sections 21 23 of the medical devices regulations regulations. 801 125 medical devices for use in teaching law enforcement research and analysis. 1 2 policy statements medical devices offered or imported for sale or use in canada must meet the labelling requirements listed in sections 21 23 of the regulations. Labeling regulatory requirements for medical devices gpo 017 012 00327 3 2 75 pb 86 184348 as 11 95.

Medical device labeling is considered as important as classifying a product or creating an insulation diagram. United states food and drug administration european medical device directive etc. The general labeling requirements for medical devices are contained in 21 cfr part 801. Medical device reporting mdr establishment registration 21 cfr part 807.

801 122 medical devices for processing repacking or manufacturing. 801 128 exceptions or alternatives to labeling requirements for medical devices held by the strategic national stockpile. An interlaboratory comparison of analytical methods for ethylene oxide pb 86. 801 127 medical devices.