MCA MCA-F-501MCA-F-501/01, version 2 – 24 January 2025
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
MCA-F-501/01, version 2 – 24 January 2025 is the official MCA identifier for “Clinical Trial Application Form”. MCA-F-501/01, version 2 – 24 January 2025 is the official identifier MCA uses for this instrument.
- Instrument
- MCA-F-501
- Full name
- MCA-F-501/01, version 2 – 24 January 2025
- Category
- Clinical Trials
- Source publication
- English
- Readable HTML
- 1 language version
- Published
- —
- Effective
- —
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Each version has stable passage anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
Clinical Trial Application Form
Complete eight-page clinical trial application, version 2 dated 24 January 2025. It expressly includes medical devices among investigational products and records trial identity, sponsors, investigators, sites, product details and applicant declarations. Conditional medicinal-product fields and phase terminology are preserved as printed; they are not imposed on every medical-device or diagnostic study. Later revisions and current applicability remain unverified.
MCA-F-501/01, version 2 – 24 January 2025 is the official identifier MCA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.