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January 29, 2026
Approximately 5 minutes
Amending Medical Device Dealer's Licence in Singapore
Amending Medical Device Dealer's Licence in Singapore
1. Overview
You must notify the Health Sciences Authority (HSA) of changes to your medical device dealer's licence details, such as medical device risk classification, Quality Management System (QMS) certification, and site details. Failure to notify HSA of changes to any particulars declared during the licence application will affect the validity of existing licences. Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/amend-licence
2. Amendment Types
Changes requiring an amendment application include:
- QMS certification type.
- Certification body.
- Renewed certificate and expiry date.
- Scope of operations.
- Site address (including changes to approved site addresses in the QMS certificate or addresses of outsourced providers).
Refer to GN-02 Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical Devices for a list of changes. Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/amend-licence
3. Application Process
Submit an Amendment application via SHARE at https://share.hsa.gov.sg/Login. Refer to the Applicant User Manual at /medical-devices/e-services for the submission process. Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/amend-licence
4. Required Documents
For changes to QMS certification:
- Submit the relevant QMS certificate from the accredited Certification Body or a declaration letter as a supporting document.
- For changes to certification body: Submit the updated QMS certificate from the new accredited Certification Body (existing certificate becomes invalid).
- For renewed certificate and expiry date: Submit the renewed QMS certificate from the accredited Certification Body.
- For scope of operations: Submit the updated QMS certificate from the accredited Certification Body.
- For site address: Submit the updated QMS certificate from the accredited Certification Body.
Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/amend-licence
5. Fees and Turnaround Time
No specific information on fees or turnaround times is provided on the page. Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/amend-licence
6. Important Notes
- Notify HSA of all changes to declared particulars to maintain licence validity.
- Examples of changes are provided in a table format, all requiring the updated or relevant QMS certificate as a supporting document.
Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/amend-licence
7. Updates
Last updated: 31 Dec 2018. Source: https://www.hsa.gov.sg/medical-devices/dealers-licence/amend-licence
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