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English — complete authored official conditional announcement

MDA/GD/0072 implementation announcement — GD0072 Change Management for Registered Medical Devices — conditional implementation announcement

Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.

Link directly to a passage with its anchor — for example #source-paragraph-1 — to open it highlighted. This reference version is generated from the authority’s publication and does not replace it. Language: English.

Medical Device Authority (MDA) wishes to inform all industry players that a new guidance document, MDA/GD/0072 Change Management for Registered Medical Devices, has been published and will replace the current guidance document, MDA/GD/0020 Change Notification for Registered Medical Devices.

However, please be informed that the new guidance document has not yet been implemented and will only take effect following the official launch of MedCAST 3.0. Until such implementation takes effect, the current guidance document, MDA/GD/0020 Change Notification for Registered Medical Devices, shall remain applicable and in force.

All stakeholders are advised to take note of this update and make the necessary preparations accordingly for the upcoming implementation.

To access the guidance document, please CLICK HERE.

For further inquiries, please contact:

Notification Amendment Unit

Pre-Market Control Division (BKPP)

Prepared by: Strategic Policy & Planning Division (POLICY)

Uploaded by: Corporate Communication Division