MDA Issued Fourth Edition Guidance Document “Change Notification for Registered Medical Device” (MDA/GD/0020)
On November 21, 2022, the MDA has announced the release of the Fourth Edition Guidance Document “Change Notification for Registered Medical Device” (MDA/GD/0020). This guidance document is a revision from the Third Edition that was issued in November 2018, to provide the medical device industry a guidance on the categories of changes, the principles of change categorization, and what should be done by the registration holder in relation to each category of change to its registered medical device.
The key points of the revision are as follows:
- Addition of Editorial Changes in the Terms and Definitions.
- Editorial changes are simple clarifications that do not alter the substantive meaning of the information. Editorial changes may include punctuation changes, grammar corrections, typographical correction, reordering existing material, rephrasing sentences that does not alter the content and adding headers for ease of use.
- Changes that are considered as editorial are exempted from submission of change notification under the changes to the labelling of medical devices.
- Revision on the following clauses:
a) Clause 5.5.6 Changes to registered medical devices registration information (Category 2)
b) Clause 5.6.2 Changes in design or specifications of a registered medical device (Category 3)
c) Clause 5.6.3 Changes to labelling of medical devices (Category3)
d) Clause 5.6.4 Changes to registered medical devices registration information (Category 3)
e) Clause 5.7 Changes to medical devices due to a mandatory reportable incident and/or field corrective action, in which establishments shall submit a change notification based on Clause 5 for the purpose of FCA submission by referring to MDA/GD/0013, Field Corrective Action (FCA)
f) Clause 5.8 Changes to medical devices due to EU’s recent regulatory framework transition to Medical Devices Regulation (MDR) and IVD Regulation (IVDR).
g) Clause 6.0 Notification process
h) Clause 7.0 Requirements for Change Notification
i) Clause 8.0 Turnaround time
Further information and details on Fourth Edition Guidance Document “Change Notification For Registered Medical Device” (MDA/GD/0020), please refer to this link.
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