Amend a medical device dealer's licence

Applicant information section

As an applicant, you are responsible to liaise with us on all issues regarding the applications submitted, including input requests.

It is the responsibility of the company to keep information, as well as contact information, of the applicant up-to-date in a timely manner.

Applicant information of all licences, registrations may be updated collectively at "Global Update of Applicant Details" under others@medics.

Company information (company name, address, contact etc.)

You must notify us of changes to your company information, such as company name, business address, contact information and contact person information.

To update company information, log in to MEDICS Change of Business Information.

Upon approval, the new information will be updated for all the dealer’s licences you hold.

Unique Entity Number (UEN)

If there is a change in legal entity (i.e. change in UEN), you need to create a new CRIS account.

All dealer’s licences related to the former UEN will no longer be valid and a licence cancellation will need to be filed. You will need to apply for new dealer's licences under the new CRIS account with the valid UEN.

You are responsible for ensuring the risk classification is accurate for the medical devices under your dealer's licences.

To update the risk classification, log in to the MEDICS Amendment of Licence e-service.

If there is a change in your Quality Management System (QMS), you have to file for an update via MEDICS Amendment of Licence e-service.

The relevant QMS certificate from the Certification Body or a declaration letter has be submitted as a supporting document with your licence amendment application:

• ISO 13485.
• GDPMDS.
• Declaration of Exemption from GDPMDS certification (Annex 1)46 KB.
• Declaration of Conformity to a QMS (Annex 5)47 KB.

If you have changed to another certification body, the existing QMS certificate issued by the former certification body would no longer be valid.

You will need to update your licences with the new certificate as part of a licensed dealer's duties and obligations. Submit the new QMS certificate issued by logging in to MEDICS Amendment of Licence e-service.

To submit a renewed QMS certificate:

1. Log in to the MEDICS Amendment of Licence e-service.
2. Submit your new valid QMS certificate with your licence amendment application.

If you have updated your QMS certification scope:

1. Log in to the MEDICS Amendment of Licence e-service and update the Scope of operations.
2. Submit your updated QMS certificate with the updated scope in your licence amendment application.

Medical devices that are subjected to cold chain management (storage conditions of 8°C and below) require special storage and handling conditions. 

To include or remove this activity in your scope of operations:

1. Log in to the MEDICS Amendment of Licence e-service and update the scope of operations.
2. Update QMS certification type by checking the appropriate check box to add or remove cold-chain management activities.
3. Submit your updated QMS certificate with your licence amendment application.

You need to notify us if there are changes to your approved site addresses listed in your existing QMS certificate. This includes addresses of third party logistic service providers, where your outsourced activities are conducted.

To add or remove a site address:

1. Log in to the MEDICS Amendment of Licence e-service and update Site Address(es).
2. Submit your updated QMS certificate with the new site addresses.

Changes to the list of Class A medical devices submitted by device dealers (importers and manufacturers) during licence application shall be updated prior to import and supply of the devices.

To submit your updates:

1. Log in to the MEDICS Amendment of Licence e-service.
2. Select the option for Submission of Update of Class A Medical Device Exemption List.

Note: If your company had previously declared that it does not deal with any Class A medical devices but you later decide to deal in such devices, you will need to submit the updates accordingly as above.