As initiated from 1 September 2019, Hong Kong Medical Device Division (MDD) will continue the trial scheme to simplified application and approval process of Class II/III/IV general medical device listing through Expedited Approval Route until 31 December 2020. As for some of the requirements that must be met by the applicant are as follows:
a. There are no reported deaths or serious injury associated with the device (local and worldwide)
b. There are no active recalls, field safety corrective actions or adverse incidents (local and worldwide) c. Two or more valid, *independent regulatory agencies’ approval has been obtained for at least three years
d. There is at least one substantially equivalent device listed under the Medical Device Administrative Control System (MDACS)
*“Independent regulatory agencies’ approval” means the status of a marketing approval document that is not dependent on the approval status of another marketing approval document. The applicant should provide full set of marketing approval document (such as licenses, certificates, approval documents, declarations, etc.) to demonstrate validity and independence.
The duration of the trial scheme evaluation will take 2 weeks after the document is received and kindly note, only existing local responsible person (LRP) shall be able to participate in the trial scheme.
Applicants who want to submit applications through the Scheme must sign and submit the declaration in Appendix 1, prepare a device profile in Appendix 2 to MDD together with application form and dossier. For the preparation of application form and dossier, please refer to Guidance Notes GN-02 (Guidance Notes for Listing Class II/III/IV Medical Devices).