Medical Device Labeling Requirements

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.

Medical device labeling requirements.

801 122 medical devices for processing repacking or manufacturing. 801 125 medical devices for use in teaching law enforcement research and analysis. Medical device labeling is considered as important as classifying a product or creating an insulation diagram. 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.

Medical device reporting mdr establishment registration 21 cfr part 807. Manufacturers both domestic and foreign and initial distributors importers of medical. Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr. United states food and drug administration european medical device directive etc.

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. Device advice introduction to labeling requirements for medical devices including advertising over the counter exemptions in vitro diagnostics investigational devices quality system. 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. 801 128 exceptions or alternatives to labeling requirements for medical devices held by the strategic national stockpile.

801 127 medical devices. General device labeling 21 cfr part 801 use of symbols. Labeling regulatory requirements for medical devices gpo 017 012 00327 3 2 75 pb 86 184348 as 11 95. 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.