Apr 3, 2014
Canadian medical device market regulators have issued updated submission forms for Medical Device License (MDL) applicants.
Manufacturers and sponsors seeking MDLs for Class II, III or IV devices should be aware of these changes. Applicants must submit updated versions of these forms to Health Canada going forward.
Medical device market regulators in Canada have added 11 new items to their list of recognized standards, removed six and amended another 27.
Standards newly recognized by Health Canada include IEC and ISO standards covering various electrical medical device components, implantable devices and IVDs.
Health Canada has released final guidance on supporting evidence requirements for Class III and Class IVC medical device license applications. The guidance specifies scientific information requirements for manufacturers submitting Class III and Class IV device license applications, excluding makers of Class III and IV IVD products. (Health Canada plans separate updated guidance on higher-risk IVDs in the future.)