Canada will follow the International Medical Device Regulators Forum unique device identification guidelines to the "T" as it works toward the national implementation of the tracking system. Mass Device reports that federal regulator Health Canada has no plans to add any Canada-specific guidelines at this time.
The IMDRF describes itself as a "forum to discuss future directions in medical device regulatory harmonization."
Health Canada's recent decision is significant because country-specific labeling threatens to gum up the global system, the former FDA official who spearheaded UDI in the U.S., Jay Crowley, told FierceMedicalDevices in a prior interview.
He said that unlike Canada, other countries or regions seek to add additional data elements to UDI for their own purposes. The U.S. wants to integrate UDI into its Sentinel post-market surveillance system, while European regulators view UDI as means to track cross-border trade, and China wants to link UDI to government reimbursement, he explained. The problem is that additional or country-specific uses of UDI require country-specific labeling and add to the system's complexity.
But Crowley stressed that the presence of individual goals need not doom harmonization efforts, saying: "Everyone recognizes that different countries will have different data needs, but as long as the core data is the same, additional elements might be added [to the device identifier] to meet certain regulatory needs of different countries, and that's ok."
By sticking to the core, internationally agreed-upon data elements, Canada ensures device availability. "If manufacturers start having to repackage, or relabel or over-label product, that becomes very expensive and complex, and the devices companies would have to decide whether it's worthwhile [to sell product there] from a business perspective."
The IMDRF is a forum that facilitates medical device regulatory harmonization. Crowley predicted that the harmonization efforts will result in UDI requirements that are "similar, but not the same" across countries. So it is unlikely that other countries will follow Canada's lead and follow the IMDRF guidelines precisely, without requiring their own unique data elements, but that doesn't mean the guidelines will be ignored completely.
Canada's decision should please device companies because it will simplify the manufacturing protocol in that country.
- read the Mass Device article
- here are the IMDRF guidelines (PDF)
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