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 31^st 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 31^st 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. 1. The applicant shall be an existing LRP;
2. 2. There are no reported deaths or serious injuries associated with the device (local and worldwide);
3. 3. There are no active recalls, field safety corrective actions, or adverse events (local and worldwide); and
4. 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.

 

 

References:
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