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International Medical Device Regulators Forum

The purpose of the IMDRF is to accelerate international medical device regulatory harmonization and convergence

http://www.imdrf.org/

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PAGE TITLE
International Medical Device Regulators Forum | imdrf.org Reviews
<META>
DESCRIPTION
The purpose of the IMDRF is to accelerate international medical device regulatory harmonization and convergence
<META>
KEYWORDS
1 about imdrf
2 work items
3 consultations
4 documents
5 meetings
6 stakeholders
7 safety information
8 recent updates
9 ghtf archive
10 noticeboard
CONTENT
Page content here
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about imdrf,work items,consultations,documents,meetings,stakeholders,safety information,recent updates,ghtf archive,noticeboard,stakeholder views,mailing list,item suggestions,document suggestions,member websites,official observers,privacy statement
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International Medical Device Regulators Forum | imdrf.org Reviews

https://imdrf.org

The purpose of the IMDRF is to accelerate international medical device regulatory harmonization and convergence

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1

Request for expressions of Interest to participate in the IMDRF TOC pilot plan

http://www.imdrf.org/consultations/cons-rps-toc-eoi-150721.asp

Request for expressions of Interest to participate in the IMDRF TOC pilot plan. Request for expressions of Interest to participate in the IMDRF TOC pilot plan. The International Medical Device Regulators Forum (IMDRF) has recently published the IMDRF Table of Contents (ToC) Pilot Plan. Currently the participating regulating authorities are Australia (TGA), Brazil (ANVISA), Canada (Health Canada), China, the European Union (Notified Bodies) and the United States (USFDA). Expressions of interest or any que...

2

Meetings

http://www.imdrf.org/meetings/meetings.asp

The next IMDRF Meeting will take place in Florianopolis (Brazil). All interested parties are invited to attend DITTA Workshop on 12 September and IMDRF Stakeholders Forum on 14 September. For more information (including program and logistics) and for registration, please visit the official website of the meeting http:/ imdrf.anvisa.gov.br. We are grateful for your continued interest in the work of IMDRF. For a list of GHTF meeting minutes, see the GHTF Archived Documents. 8 to 10 March 2016. IMDRF Presen...

3

Consultations

http://www.imdrf.org/consultations/consultations.asp

IMDRF is currently reviewing the following consultations:. Competence, Training and Conduct Requirements for Regulatory Reviewers. Melissa Torres - Melissa.Torres@fda.hhs.gov. RPS Table of Contents Pilot. Open until enrolment objects are met. Patient Registry: Essential Principles. RPS - Common Data Elements for Medical Device Identification. Regulated Product Submission (RPS) Working Group. Request for expressions of Interest to participate in the IMDRF TOC pilot plan. Medical Device Single Audit Progra...

4

International Medical Device Regulators Forum

http://www.imdrf.org/index.asp

Oucome statement from Brasilia meeting available. RPS Table of Contents Pilot underway. International Medical Device Regulators Forum. The International Medical Device Regulators Forum (IMDRF) was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonization. Australia - Therapeutic Goods Administration. Brazil - National Health Surveillance Agency (ANVISA). Canada - Health Canada. China, China Food and Drug Administration. Russia, Russian Minstry of Health.

5

Regulated product submission (RPS) Table of contents

http://www.imdrf.org/consultations/cons-smd-samd.asp

Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Controls. Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Controls. A proposed document has been released by the International Medical Device Regulators Forum (IMDRF) Standalone Medical Device Software Harmonization (SaMD) Working Group for public comment. This consultation is now closed. Australia - Therapeutic Goods Administration. Canada - Health Canada.

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Tag - Guidance - Software in Medical Devices

http://blog.cm-dm.com/tag/Guidance

Software in Medical Devices. Software in Medical Devices. Software in Medical Devices. Friday 19 August 2016. Three new FDA guidances. On Friday 19 August 2016, 13:48 - Regulations. The FDA released three new FDA guidances in July 2016:. Two draft guidances on Deciding When to Submit a 510(k) for a Change to an Existing Device,. The final guidance on General Wellness: Policy for Low Risk Devices. Wednesday 10 August 2016. MEDDEV 2.1/6 2016. On Wednesday 10 August 2016, 10:09 - Regulations. FDA draft guid...

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Tag - FDA - Software in Medical Devices

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Software in Medical Devices. Software in Medical Devices. Software in Medical Devices. Friday 19 August 2016. Three new FDA guidances. On Friday 19 August 2016, 13:48 - Regulations. The FDA released three new FDA guidances in July 2016:. Two draft guidances on Deciding When to Submit a 510(k) for a Change to an Existing Device,. The final guidance on General Wellness: Policy for Low Risk Devices. Friday 5 February 2016. New FDA draft guidance on interoperable medical devices. Friday 29 January 2016.

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Welcome - imdrf

CLOSED - Registration for Stakeholders Forum. Registration for DITTA Workshop. Auditorium, Costão do Santinho Resort. Estr Ver. Onildo Lemos, 2505 - Praia do Santinho, Florianópolis - SC, 88058-700. OUTCOMES AND PRESENTATIONS FOR IMDRF 10 ARE PUBLISHED. The outcomes and the presentations of the 10th IMDRF Meeting are available at: http:/ imdrf.org/meetings/meetings.asp. This field is mandatory. All interested parties are invited to attend DITTA Workshop on September 12. 14 September 2016, 9:00 18:00.

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International Medical Device Regulators Forum

Essential Principles Consultation Open. Registration open for March Forum. Links to NCAR safety information. RPS Table of Contents Pilot underway. International Medical Device Regulators Forum. The International Medical Device Regulators Forum (IMDRF) was conceived in February 2011 as a forum to discuss future directions in medical device regulatory harmonization. Australia, Therapeutic Goods Administration. Brazil, National Health Surveillance Agency (ANVISA). Canada, Health Canada.

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