Medsafe SponsorSponsor Requirements
Sponsor Requirements is the official Medsafe identifier for “Regulatory Requirements for Sponsors”. Sponsor Requirements is the official identifier Medsafe uses for this instrument.
- Instrument
- Sponsor
- Full name
- Sponsor Requirements
- Category
- Registration
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- 8 articles · 1 language version
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Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
Regulatory Requirements for Sponsors
Medsafe guidance walking through the sponsor duties of the Medicines (Database of Medical Devices) Regulations 2003 regulation by regulation: Reg. 5 information required in the database, Reg. 6 information to be supplied by the sponsor, Reg. 7 declaration, Reg. 8 updated information, Reg. 9 arrangements to ensure compliance, Reg. 10 prohibited statements (no implication of Ministry endorsement from notification), and Reg. 14 offences. Page revised 10 May 2011 per its own stamp; ingested from the exact official HTML with sec-1..sec-7 anchors keyed to the printed regulation numbers.
Sponsor Requirements is the official identifier Medsafe uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.