Wanted: Medical Device Volunteers for IMDRF Pilot
Medical device companies looking to get their products approved in more than one jurisdiction are being sought by the International Medical Device Regulators Forum.
IMDRF, a multinational group of device regulators working to harmonize global standards and regulations, is seeking volunteers for a pilot project to evaluate table of contents structures for premarket applications. The ToC documents are expected to be used by companies when filing medical device submissions to multiple regulators. They define the location for both IMDRF and regional content for all submission types.
Slated to begin this September, the pilot is expected to remain open for 12 months, with an eye on finalizing findings by November 2016.
The pilot’s objectives, according to an IMDRF document, are the following:
- Develop and validate documentation supporting the use of the IMDRF ToCs, based on industryfeedback;
- Identify possible industry challenges and develop ways to address them;
- Provide industry and regulators with the opportunity to use ToCs with real submissions in a controlled setting;
- Evaluate the proper usage of the ToC headings, including the appropriate placement of documents within the headings and submission of complete and relevant content;
- Identify additional ToC harmonization opportunities; and
- Establish and ensure ToC pilot technical guidelines are fit for purpose, and to the extent possible, are harmonized among all of the players.
Australia, Brazil, Canada, China, the EU and the U.S. are participating in the current pilot. A previous ToC pilot used historical submissions for products, but, at the time, there were no guidelines for building a regulated product submission. IMDRF is looking to develop a Health Level Seven Regulated Product Submission exchange standard to serve as the international standard for medical device and human pharmaceutical submissions.
Several IMDRF countries are conducting corresponding regional pilots. Brazil’s Agência Nacional de Vigilância Sanitária, for example, is encouraging parties to indicate their interest by copying in their request to IMDRF.