Hong Kong's Medical Device Division Updates Compliance Regulations
Earlier this year, Hong Kong's Medical Device Division (MDD) announced that they now accept marketing approvals obtained from China's National Medical Products Administration (NMPA) as proof of compliance for Class III/IV General Medical Devices under the "Essential Principles of Safety and Performance of Medical Devices". The NMPA marketing approval for In Vitro Diagnostic Medical Devices (IVDMD) on a trial basis is extended until December 31, 2022.
Continued Expedited Approval Scheme
In addition to the updates in the trial scheme, MDD has also announced the continuation of the expedited approval scheme for Class II/III/IV General Medical Devices on a regular basis. These updates are reflected in the latest application form.
Eligibility Criteria for Expedited Approval
Applicants eligible for this expedited approval scheme must comply with the following criteria:
- The applicant shall be an existing LRP;
- There are no reported deaths or serious injuries associated with the device (local and worldwide);
- There are no active recalls, field safety corrective actions, or adverse events (local and worldwide);
- The device has two or more valid, independent Marketing Approvals from China, and/or GHTF founding.