MDA MDAMDA/GD/0041, First Edition
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
MDA/GD/0041, First Edition is the official MDA identifier for “Change of Ownership for Medical Device Registration”. MDA/GD/0041, First Edition is the official identifier MDA uses for this instrument.
- Instrument
- MDA
- Full name
- MDA/GD/0041, First Edition
- Category
- Registration
- Source publication
- English
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- 1 language version
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Change of Ownership for Medical Device Registration
Complete 14-page first-edition guidance dated December 2016, including normative ownership-application and declaration annexes. It addresses ownership of a medical-device registration, including replacement of an authorized representative. Registration ownership, establishment licensing and manufacturer identity remain distinct roles. Its general requirements require pending applications to be completed or withdrawn and state an estimated 30-working-day target for complete submissions. This source-preservation review does not certify whole-country completeness or blanket current legal effect.
MDA/GD/0041, First Edition is the official identifier MDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.