Amend a medical device dealer's licence
You must notify us of changes to your dealer's licence on details such as medical device risk classification, QMS certification and site details.
Last updated 13 March 2026
You must notify us whenever there is a change to any particulars that was declared when you applied for the dealer's licence. Failure to notify us will affect the validity of your existing licences.
How to submit an amendment
For changes to your dealer's licence, submit an Amendment application in SHARE. You can refer to Applicant User Manual for submission process.
Refer to GN-02 Guidance on Licensing of Manufacturers, Importers and Wholesalers of Medical devices for a list of changes.
Below are examples of the type of changes that require you to submit an Amendment application.
Change type | Details |
|---|---|
QMS certification type | For changes to your Quality Management System (QMS), the relevant QMS certificate from the accredited Certification Body or a declaration letter has to be submitted as a supporting document with your licence amendment application. |
Certification body | If you have changed to another certification body, the existing QMS certificate issued by the former certification body would no longer be valid. The updated QMS certificate from the accredited Certification Body has to be submitted as a supporting document with your licence amendment application. |
Renewed certificate and expiry date | The renewed QMS certificate from the accredited Certification Body has to be submitted as a supporting document with your licence amendment application. |
Scope of operations | The updated QMS certificate from the accredited Certification Body has to be submitted as a supporting document with your licence amendment application. |
Site address | You need to notify us if there are changes to your approved site addresses listed in your existing QMS certificate. This includes addresses of outsourced providers. The updated QMS certificate from the accredited Certification Body has to be submitted as a supporting document with your licence amendment application. |