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Working group

Artificial Intelligence Medical Devices

The working group’s mandate was to deliver on Key Terms and Definitions for Machine Learning-enabled Medical Devices.

Working group

Principles of In Vitro Diagnostic (IVD) Medical Devices Classification

Review and update the GHTF/SG1/N045:2008 Principles of In Vitro Diagnostic (IVD) Medical Devices Classification.

Working group

Medical Device Cybersecurity Guide

Manage cybersecurity risks in medical devices through a life-cycle approach. Striking the right balance between pre-market and post-market requirements.

Working group

Medical Device Clinical Evaluation

Improve the effectiveness and efficiency of the pre-market review process by promoting increased global harmonization.

Working group

Personalized Medical Devices (PMD)

Harmonize the regulatory requirements for medical devices that are intended for a particular individual, considering unique characteristics and risks associated with each type of device.

Working group

Good Regulatory Review Practices

Develop good review practices for pre-market reviews and evaluations.

Working group

Regulated Product Submission

Harmonize the format and content of regulatory submissions.

Working group

Standards - Improving the quality of international medical device standards for regulatory use

Improve the process of developing international standards used for regulatory purpose in the medical technology domain.

Working group

Unique Device Identification (UDI) Application Guide

Development of non-binding rules for creating, using, and maintaining unique device identifiers and related activities.

Working group

Software as a Medical Device (SaMD)

Develop international definitions, risk category framework, and quality management system.

Member sites

Artificial Intelligence Medical Devices

Principles of In Vitro Diagnostic (IVD) Medical Devices Classification

Medical Device Cybersecurity Guide

Medical Device Clinical Evaluation

Personalized Medical Devices (PMD)

Good Regulatory Review Practices

Regulated Product Submission

Standards - Improving the quality of international medical device standards for regulatory use

Unique Device Identification (UDI) Application Guide

Software as a Medical Device (SaMD)

Member sites

Regional harmonization initiatives

Official observers

Affiliate members

Affiliates

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Regional harmonization initiatives

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