Hong Kong’s Medical Device Division (MDD) have announced earlier this year that they can now accept marketing approvals obtained from China’s National Medical Products Administration (NMPA) as a proof of compliance for class II/III/IV General Medical Device under the “Essential Principles of Safety and Performance of Medical Devices”. While NMPA marketing approval for In Vitro Diagnostic Medical Devices (IVDMD) on a trial basis is extended until 31st December 2022.
Furthermore, current trial scheme accepting marketing approval from the Ministry of Food and Drug Safety (MFDS) of Korea as a proof of compliance of class II/III/IV General Medical Device is extended until 31st December 2022.
Aside from the changes in the trial scheme, MDD also announced the continuation of the expedited approval scheme for class II/III/IV General Medical Devices on a regular basis. These changes can be seen in the latest application form.
Applicants eligible for this expedited approval scheme must follow and comply with the following criteria:
- 1. The applicant shall be an existing LRP;
- 2. There are no reported deaths or serious injuries associated with the device (local and worldwide);
- 3. There are no active recalls, field safety corrective actions, or adverse events (local and worldwide); and
- 4. The device has two or more valid, independent Marketing Approvals from China, and/or GHTF founding members (Also see Note D001). While marketing approvals provided must cover the same make and model of the device concerned.
Announcement of the changes to the respective trial schemes for accepting marketing approvals obtained from the NMPA and MFDS
The Regularization of the Expedited Approval Scheme for Class II/III/IV General Medical Device Listing Applications