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GHTF IMDRF RPS Communication - 24 January 2019 - PDF (72KB)

赵静曼 9/4/2022 浏览 186 GHTF 世界范围

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IMDRF RPS Communication - 24 January 2019 - PDF (72KB)[附网盘链接]由The Global Harmonization Task Force于之前发布，适用于世界范围。

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IMDRF RPS Communication - 24 January 2019 - PDF (72KB)[附网盘链接]
IMDRF RPS Communication - 24 January 2019 - PDF (72KB)[附网盘链接](截图)

 

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January 24, 2019

The Regulated Product Submission (RPS) proposal was endorsed as a New Work Item (NWI) by IMDRF at

its inaugural meeting in Singapore in March 2012. The proposal, as endorsed, included the objective of

establishing a comprehensive harmonized structure for premarket medical device submissions. The

harmonized structure was established as the Table of Contents (ToC) which was first introduced in

February 2013 for both IVD and non-IVD devices and has undergone revisions as recently as March

2018.

In order to evaluate the benefits and challenges of utilizing the ToC structure, an IMDRF pilot program

involving Australia, Brazil, Canada, China, the European Union, and the United States was initiated

October 1, 2015, in addition to regional pilots that were initiated about the same time. The pilot

program ended December 2017 with 17 devices accepted into the pilot. To date, 15 applications have

been approved from those submitted. The following conclusions were drawn from the pilot:

• The consistent structure of well-defined ToC sections and numbering, along with the regional

classification matrix, allowed for better navigation through the applications and easier access to

the data.

• Reviewers generally like the ToC format.

• The structure is adequate for manufacturers to utilize, but additional guidance would be helpful

and a stronger commitment for implementation by regulators is essential for manufacturers to

begin investing resources.

• Issues encountered to date are provided in the below table.

In addition to the ToC pilot, two rounds of RPS test cases were conducted to evaluate a "fit for purpose"

of the Health Level Seven (HL7) RPS Standard to allow electronic exchange of information related for

premarket medical device applications. Both reports have been published on the IMDRF website.

Members of the IMDRF RPS WG continue to support the concept of utilizing a harmonized ToC

application format and see value in the establishment of subsequent harmonized electronic submissions

of regulated health products. We do acknowledge that it may be a long-term effort to implement

harmonized electronic submissions as common practice.

In the interim, we confirm that the ToC structure is an agreeable format capable of supporting the

regulatory submission requirements for all member countries. Some members have already announced

their intention to adopt the ToC while others are reviewing how the ToC structure may be introduced as

an alternative submission format within their current regulatory environments.

The following feedback was received from pilot participants:

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