License maintenance is an important consideration for manufacturers selling medical devices in Singapore as failures to comply could lead to loss of market access and significantly affect sales. License Maintenance in Singapore consists of paying an Annual Retention Fee, maintaining advertising compliance and obtaining approval prior to importing products that have changed from the original Registration Certificate.
Annual Retention Fee
SMDR listings do not expire as long as the annual listing fee is paid each year and the product remains the same. The SMDR annual listing fees are S$36 for Class B, S$62 for Class C, and S$124 for a Class D device listing.
The following changes to your product will require Asia Actual to submit a Registration Modification to the HSA. If you are considering changes to your product, please reach out for support evaluating whether a modification will be required. The HSA’s full guidance (GN-21), including details and flowcharts, can be found here.
The HSA has 4 types of Changes that require approval prior to implementation of the change:
Technical Changes for Class C and D medical devices affect the safety, quality or efficacy of these medical devices.
Review Changes for Class B that affect safety, quality or efficacy including addition of new models or changes to indications for use.
Administrative Changes are for administrative documents and information submitted at the point of registration of the medical device.
Notification Changes are for all other changes, including removing device particulars publicly published on the SMDR listing. Notification Changes may be bundled together and notified to HSA in one change notification application.
Times for Change Notifications:
Modifications typically require about 3 months from submission to receive approval.
Changes that Require a New Registration
The following changes do not qualify for a Change Notification and would require a new registration:
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.
* Interpretations of permissible modifications can vary and it’s important to always check with your License Holder or Regulatory Professionals when considering new changes to maintain compliance and avoid losing market access.
**A change of the Product Owner or Registrant may result in the suspension or cancellation of the Device Listing on the SMDR if the change has not been approved by HSA.
Contact Asia Actual with any medical device license amendment questions in Singapore. Our local, bi-lingual regulatory experts are well positioned to assist.