Forms

(Note: The Chinese name of the Medical Device Division will be renamed with effect from 21 January 2025 while the English name remains unchanged. All issued listing certificates shall remain valid until their expiry date. For enquiry, please contact the Medical Device Division.)

The Medical Device Division (MDD) has introduced a new Medical Device Information System (MDIS) on 2 April 2024, which will offer a one-stop e-service for the industry to submit online applications for listing of medical devices (MDs) and traders under the Medical Device Administrative Control System (MDACS), as well as to report safety alerts and adverse events related to MDs.

On receiving an application, the Medial Device Division (MDD) will acknowledge the receipt via notification to the applicant’s registered email. Please note that the MDD shall take 2 weeks to acknowledge the receipt of application and assign the application number (such as ANXXXXXX, IANXXXXXX, DANXXXXXX, LMANXXXX). Applicants are advised to submit their applications as early as possible. If an applicant does not receive the acknowledgement by 2 weeks after submitting an application, he may contact the MDD to check if the submission has been received by the MDD.

The vetting and approval of an application should normally be completed within 12 weeks following the submission of the application and all the required supporting information.

To facilitate smooth transition from paper-based to online submission of the application, the key dates of rollout of e-services of MDIS and ceasing to accept paper-based submissions are set out in the MDIS theme page.

Forms are available below: