Health Canada Finalizes IVD Guidance 18 Years After Issuing Draft

June 17, 2016

Health Canada has finalized its regulations on in vitro diagnostic labeling 18 years after issuing draft guidance.

The final guidance — which took effect April 22 — offers an overview on requirements for the label, package insert, outer container label and immediate container label requirements.

An identifier that distinguishes the device and enables postmarket traceability also is required, and it can be a unique series of letters and numbers or a bar code.

The “intended use” section requirements appear fairly standard. In addition, Health Canada writes that “the package insert should indicate a brief summary and explanation of the [IVD] test and how it works, including the clinical benefits and limitations of the test with respect to the intended use.”

The directions for use should describe all of the parts or components supplied in an IVD package, and they should include appropriate warnings and precautionary statements.

Directions for use should also explain how to interpret the results, as well as storage instructions. The IVD’s expiration data does not need to appear on the package insert.

The final guidance also contains a new section on electronic labeling. Health Canada permits electronic labeling of information that would normally be found in an IVD’s instructions for use information, as long as the information is identical.

For devices that are not sold to the general public, electronic information may be provided as downloadable from the Internet and/or on electronic data storage devices such as a USB flash drive. “The electronic label or internet web address must accompany the device at the time of sale and/or delivery and be displayed in a manner that alerts the user to its purpose,” the guidance says.

Also new are the guidance’s special considerations for blood glucose monitoring systems. The devices’ intended use section should include specific information, such as whether the meter is intended for single or multiple use and whether it is intended for testing neonate samples. It also should include a statement that says the test is “not for the diagnosis of diabetes.”

Stay up to date on regulatory stories like this one by subscribing to The GMP Letter. For 30 years, devicemakers have relied on The GMP Letter for the latest on the FDA’s interpretation and enforcement of cGMPs and the Quality Systems Regulation.

View today's stories