Medical Device Labeling Requirements

The general labeling requirements for medical devices are contained in 21 cfr part 801.

Medical device labeling requirements. 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. These regulations specify the minimum requirements for all devices. Manufacturers both domestic and foreign and initial distributors importers of medical. 801 125 medical devices for use in teaching law enforcement research and analysis.

801 127 medical devices. 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. 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.

Medical device reporting mdr establishment registration 21 cfr part 807. 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. An interlaboratory comparison of analytical methods for ethylene oxide pb 86.

Medical device labeling is considered as important as classifying a product or creating an insulation diagram. Labeling regulations pertaining to medical devices are found in the following parts of title 21 of the code of federal regulations cfr. Device advice introduction to labeling requirements for medical devices including advertising over the counter exemptions in vitro diagnostics investigational devices quality system. 801 128 exceptions or alternatives to labeling requirements for medical devices held by the strategic national stockpile.