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Regulated Product Submission Table of Contents Pilot

Background

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

  1. Non-IVD Market Authorisation
  2. 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]

CONTENT:

  • 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

Region Name Title Email Phone
IMDRF Pilot Coordinator Daniel Yoon Senior International Regulatory Associate daniel.yoon@canada.ca 613-716-5762
Australia Dr Elizabeth McGrath Director
Conformity Assessment
Medical Devices Branch
Therapeutic Goods Administration
elizabeth.mcgrath@tga.gov.au +61 2 6232 8216
Brazil Augusto Geyer Manager of IVDs
General Office of Medical Devices
toc.pilot@anvisa.gov.br +55 61 3462 6650
Canada Sarah Chandler A/Manager
Device Licensing Services Division
Medical Devices Bureau
Health Canada
device_licensing@hc-sc.gc.ca 613-957-7285
China Yue Min Reviewer
Division 2
Center for Medical Device Evaluation
CFDA
minyue@cmde.org.cn +86-10-68390640
Shiqing Zhang Project Coordinator
General Coordination Division
Center for Medical Device Evaluation
CFDA
zhangsq@cmde.org.cn +86-10-68390674
EU Maria Carleton Technical Assessment Manager
HPRA
devices@hpra.ie +35316764971
USA Jodi Hope N. Anderson Policy Analyst
Office of Device Evaluation Center for Devices & Radiological Health
jodi.anderson@fda.hhs.gov 301-796-9299

IMDRF Documents for use in the Pilot

The following documents can be found on IMDRF's website:

  • N26: ToC Pilot Plan
  • N13: IVD Market Authorization ToC
  • N9: nIVD Market Authorization ToC

Regional Documents

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.

Region Details
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.

Feedback

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.