GHTF · International guidance
GHTF/SG1/N065:2010
Registration of Manufacturers and Listing of Medical Devices
International Medical Device Regulators ForumGHTF/IMDRFTechnical guidance
International guidance
This document provides international technical guidance. Publication here does not establish its adoption or binding effect in any national market. Check the applicable national requirements and the issuing authority’s latest publication.
Source identity
- Issuing body
- GHTF/IMDRF
- Reference
- GHTF/SG1/N065:2010
- Published (source metadata)
- August 2010
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About this guidance
Registration of Manufacturers and Listing of Medical Devices
Guidance on manufacturer registration and device listing requirements. Outlines regulatory authority notification procedures and database submission.