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GHTF Washington D.C meeting outcome statement - PDF (57kb)

赵静曼 12/18/2022 浏览 326 GHTF 全球

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OUTCOME STATEMENT

of the IMDRF-6 MANAGEMENT COMMITTEE

16 to 18 September 2014

The sixth meeting of the Management Committee (MC) of the International Medical Device

Regulators Forum (IMDRF) took place in Washington, DC (United States of America), from

16 to 18 September 2014. The meeting was chaired by the United States of America. The

MC consists of regulators from Australia, Brazil, Canada, China, the European Union, Japan,

the Russian Federation, and the United States of America. Representatives of the World

Health Organization (WHO) as Official Observer and Asia-Pacific Economic Cooperation

(APEC) as an Affiliate Organization also participated.

On the first day, the MC discussed the progress achieved on the on-going work items:

1. Medical Device Single Audit Program (MDSAP)

2. National Competent Authority Report (NCAR)

3. Recognized Standards

4. Regulated Product Submission (RPS)

5. Software as a Medical Device (SaMD)

A Revised New Work Item Proposal (NWIPs) and two NWIPs were also presented to

the MC:

1. Medical Device Patient Registries - MDEpiNet

2. Development of common terminology and code related to adverse

events of medical devices – Japan MC Delegation

3. Harmonization of Good Clinical Practices - GMTA

In the afternoon, an open session was held that included MC members, Official

Observers, and Invited Observers. Brief statements were provided by the WHO as an

Official Observer, as well as the following Invited Observers:

a. Asia-Pacific Economic Cooperation (APEC), Life Science Innovation

Forum (LSIF), Regulatory Harmonization Steering Committee (RHSC)

b. Pan Africa Harmonization Working Party (PAHWP)

c. Pan American Health Organization (PAHO)

d. Argentina

e. Cuba

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