Health Canada is seeking industry feedback on guidance that describes its plan to formally implement the Table of Contents (ToC) structure, established by the International Medical Device Regulators (IMDRF) for a harmonized approach to the format of medical device market authorization applications.
The implementation guidance
identifies how Health Canada will adopt ToC formats as part of its efforts to support the global convergence of documentation requirements for medical devices. Manufacturers in Canada will be expected to use the ToC formats beginning 1 April 2019—the same day in which the current Summary Technical Documentation format will be discontinued—to submit premarket applications for Class III and Class IV medical devices. The changes were first announced
“It is expected that use of the ToC will reduce time and costs for both industry and the regulator and will ultimately result in timely access to medical devices for Canadians,” Health Canada said.
The implementation approach is described in separately posted ToC guidances that address various relevant regulatory activities, which incorporated content from the IMDRF ToC documents for medical devices and in vitro
diagnostics (IVDs). It is arranged by the type of device application and includes two guidances on content and classification for Class III medical devices and IVDs and two additional guidances on content and classification for Class IV medical devices and IVDs. It also includes three related guidances regarding applications for Class II device licenses, private labels and minor changes.
A new guidance
further specifies technical guidelines to aid manufacturers in developing ToC-based submissions. This addresses assembly and system requirements as well as folder structure and file formats. It also offers considerations for content that will be submitted to multiple regions. A separate guidance
identifies conditions subject to required heading classifications for post-market interactions.
Health Canada will issue draft versions of ToC guidance and collect feedback from industry until 31 March 2020. The regulator intends to publish final versions based on one-year of real-world experience on industry’s approaches and formats.
The transition to the ToC comes after a pilot was launched in 2015 for interested manufacturers to submit regulatory dossiers using the harmonized structure established by the IMDRF Regulated Product Submission working group about six years ago. The pilot was aimed at evaluating structure adaptability from industry’s perspective when applying to more than one jurisdiction. Other ToC pilot regulators included the US food and Drug Administration (FDA) and Australia’s Therapeutic Goods Administration.
Health Canada is the only IMDRF member that has moved to formally adopt the ToC structure so far, though the regulator had previously indicated that its ToC pilot saw far fewer industry participants than anticipated.
FDA’s Center for Devices and Radiological Health (CDRH) indicated last year that it does not intend to enforce adoption of the ToC structure for manufacturers in the US. Yet CDRH is working
a new medical device single review program by building
on the learnings from existing IMDRF initiatives, such as the ToC structure and Medical Device Single Audit Program (MDSAP). Health Canada is also currently the only IMDRF member that has required
device manufacturers to transition to MDSAP this year.