When a Change Notification (CN) is required

When a Change Notification (CN) is required

You need approval from HSA prior to implementing the following changes:

• Technical changes to Class C and D medical devices.
• Review changes for Class B medical devices.
• Administrative changes that affect the Singapore Medical Device Register (SMDR) listing information.
• Notification changes.

Refer to Change Type Assessment Flowcharts1016 KB in our Guidance Notes to help you determine the Change Category.

The following changes do not qualify for a CN. Please register the medical device instead:

• Change in risk classification.
• Change in intended use of the device.
• Change of the registrable drug of a device with the registrable drug in a secondary role.
• Addition of model that does not fulfil the grouping criteria as per Guidance Notes on Grouping of Medical Devices for Product Registration.
• Addition of medical devices with device proprietary names different from the registered devices, into a device listing, unless permitted to be listed together in one SMDR listing based on Guidance Notes on Grouping of Medical Devices for Product Registration.

If you are unsure if a CN has to be submitted for changes made to your device, please contact the Medical Devices Branch (MDB).

What you need to prepare

What you need to prepare

• Current market clearance and listing (e.g. DE0012345) in the SMDR for your device.
• Relevant supporting documents1175 KB
• A complete description of the change, using the Summary Table of Change Notification1016 KB (Annex 2)

Change Notification process

Change Notification process

The Change Notification has to be submitted online in the Medical Device Information & Communication System (MEDICS@HSA).

Changes may be grouped and submitted as one CN application for medical device listings based on the following guidelines:

1. Multiple changes in one dossier for a single risk class.
2. Changes in two or more dossiers for a single risk class.
   1. Identical administrative and notification changes to multiple SMDR listings.
   2. Same new product added to multiple SMDR listings.
   3. Technical changes to the same medical device (same product identifier) that is part of multiple device listings.
3. Identical changes in different risk classes.
   1. Change in product owner.
   2. Change in manufacture and/or sterilisation site.
   3. Update of QMS certificate validity date.
   4. Addition of identical Class A accessories.

Note: When there are identical changes arising from open FSCA or reportable Adverse Events (AE) involving SMDR listings of different risk classes, please seek advice from the Medical Devices Branch prior to CN submission.

Please note that it is not possible to submit a new CN application if there is a pending CN application for the same product. In such cases, registrants can explore one of the following options:

• Withdraw the pending CN application and submit a new CN application
• Submit a new CN application once the pending CN application is completed

For applications with changes to multiple categories (e.g. notifications, administrative, technical and review changes), they shall be classified based on the most stringent category of change in that application. The fees and turn-around-time (TAT) will follow that respective category.

For more information on submitting a CN, please refer to the Guidance Notes on Grouping of Medical Devices for Product Registration.

Fees and turnaround time

Refer to medical device fees and turnaround time for more information.

For multiple changes within one Change Notification submission, fees charged will be according to the most stringent change category in the application.

You can pay online with a credit card, or by GIRO (application form227 KB). Fees paid are non-refundable, even if your application is withdrawn or rejected.

After submitting the Change Notification

After submitting the Change Notification

The device listing will either be updated or an additional device listing will be created in the SMDR.

You can view the status of your change application in your Inbox under workbench@MEDICS. You will also receive an e-mail update on its status.

Implementation

• You may implement the following changes immediately upon receipt of the acknowledgement e-mail from us:
  • Notification changes.
  • Administrative changes (only changes that fall under 6Aii/6Aiii/6Aiv of Flowchart 6A1016 KB .
• Other changes can only be implemented when the CN application is approved.