Regulated Product Submission Table of Contents Pilot
The Regulated Product Submission (RPS) proposal was endorsed as a New Work Item (NWI) by IMDRF at its inaugural meeting in Singapore (March 2012). The working group to this point has accomplished the following:
1. Established that the Health Level Seven (HL7) RPS Standard is "fit for purpose" for the electronic exchange of information related to premarket medical device applications.
2. Established a comprehensive Table of Contents (ToC) for the following premarket applications
- Non-IVD Market Authorisation
- IVD Market Authorisation
The ToC Working Group has previously conducted pilots for both of the ToC structures, using historical submissions. Regional pilots are also currently being undertaken by some IMDRF members. This pilot is being conducted with the following general objectives:
- To evaluate the adaptability of the ToC structure from an industry perspective when applying to more than one jurisdiction (simultaneously or sequentially) using real regulatory submissions
The pilot was initiated 1 October 2015, and is projected to run for a minimum of twelve (12) months or until all objectives are met. Upon conclusion, all findings will be posted on the IMDRF website.
How to Request Participation
Although the initial call for expressions of interest to participate in the ToC pilot is closed, IMDRF will welcome manufacturers requesting participation, provided they meet the inclusion criteria. Those wishing to participate in the Table of Contents (ToC) pilot must first receive formal participation confirmation from the IMDRF ToC Pilot Coordinator (Daniel Yoon, Health Canada) for their specific submission.
To request formal participation confirmation manufacturers must email the IMDRF ToC Coordinator, copying all relevant regional pilot contacts (i.e. only those that you are requesting to submit the specific submission to). The Pilot will remain open for new participants until enrolment objectives are met.
The IMDRF ToC Pilot coordinator will then provide a formal response to the request, as well as which regions have agreed to accept the submission.
Note:A minimum of two (2) regions must agree to accept the submission before it will be accepted into the IMDRF Pilot.
Specifically, the request should contain the details outlined below:
From: Industry Representative
To: IMDRF ToC Coordinator (Daniel Yoon)
CC: All relevant Regional Contacts
SUBJECT: IMDRF Participation Confirmation ‐ [DEVICE NAME]
- Full Name and contact information
- General description of the device
- Table listing the following:
|Region||Applicant/Mnf Identity||Device Name||Submission class/type||Anticipated date of submission||[EU ONLY] Name and address of NB**|
|Canada||ABC Dev||XYZ Super Device||nIVD Class III New||2015-09-21|
|Brazil||Best Dev||XYZ Super Device||New non-IVD registration||2015-12-01|
** IMPORTANT NOTE FOR EU APPLICATIONS: The manufacturer should have confirmed the NB listed is willing and able to participate in the pilot.
List of Contacts
|IMDRF Pilot Coordinator||Daniel Yoon||Senior International Regulatory Associatefirstname.lastname@example.org||613-716-5762|
|Australia||Dr Elizabeth McGrath||Director
Medical Devices Branch
Therapeutic Goods Administration
|email@example.com||+61 2 6232 8216|
|Brazil||Augusto Geyer||Manager of IVDs
General Office of Medical Devices
|firstname.lastname@example.org||+55 61 3462 6650|
Device Licensing Services Division
Medical Devices Bureau
Center for Medical Device Evaluation
|Shiqing Zhang||Project Coordinator
General Coordination Division
Center for Medical Device Evaluation
|EU||Maria Carleton||Technical Assessment Manager
|USA||Jodi Hope N. Anderson||Policy Analyst
Office of Device Evaluation Center for Devices & Radiological Health
IMDRF Documents for use in the Pilot
- IMDRF Assembly and Technical Guide for IMDRF Table of Contents (ToC) Submissions (ToC-based submissions) - PDF (227kb)
- IMDRF Assembly and Technical Guide for IMDRF Table of Contents (ToC) Submissions (ToC-based submissions) - DOCX (95kb)
- IVD ToC zip file template (45kb)
- nIVD ToC zip file template (45kb)
The following documents can be found on IMDRF's website:
- N26: ToC Pilot Plan
- N13: IVD Market Authorization ToC
- N9: nIVD Market Authorization ToC
Region specific documents supporting the IMDRF pilot are available either by webpages or through direct communication with the regional contact following acceptance into the IMDRF Pilot. The table below captures where you can expect to find the information for each region.
|Australia||The regional requirements, classification matrices, and other relevant information can be found here.|
|Brazil||The regional guidance and classification matrices are available here. As all submissions to ANVISA must be submitted by national manufacturers or Brazilian representatives of the international manufacturers we decided to keep only the Portuguese versions of the page and guidance.|
|Canada||Region specific guidance for submission compilation and submission will be sent to Pilot participants after acceptance into the Pilot.|
|China||Documents will be provided in Chinese to the applicant after the acceptance into the Pilot.|
|EU||General information and copies of the classification matrices can be found here.
Further region specific guidance for submission compilation and submission will be sent to Pilot participants after acceptance into the Pilot.
|USA||General information and copies of the classification matrices can be found here.
Region specific guidance for submission compilation and submission will be sent to Pilot participants after acceptance into the Pilot.
Final feedback should be provided in the format of the attached Excel sheet and sent directly to the IMDRF ToC Pilot Coordinator and any relevant regional contacts.