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HONG KONG: EXPEDITED APPROVAL SCHEME FOR MEDICAL DEVICE LISTING APPLICATIONS EXPANDED TO INCLUDE CLASS B/C/D IN VITRO DIAGNOSTIC MEDICAL DEVICE - August/September 2024

HONG KONG: EXPEDITED APPROVAL SCHEME FOR MEDICAL DEVICE LISTING APPLICATIONS EXPANDED TO INCLUDE CLASS B/C/D IN VITRO DIAGNOSTIC MEDICAL DEVICE - August/September 2024

  • 2024-09-17 03:42:57

The Expedited Approval Scheme for Medical Device Listing Applications has been expanded to include Class B/C/D In Vitro Diagnostic Medical Devices. Eligibility criteria remain unchanged, while some additional regulatory agencies have been recognized. Applications must be submitted through Medical Device Information System and refers to both GN-02 and GN-06.

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SINGAPORE:  Streamlining Medical Device Approval in Asia: Singapore HSA is Recognized as Reference Country by Hong Kong MDD – June/July 2024

SINGAPORE: Streamlining Medical Device Approval in Asia: Singapore HSA is Recognized as Reference Country by Hong Kong MDD – June/July 2024

  • 2024-06-20 05:49:36

In a significant step towards regional harmonization, the Hong Kong MDD announced on 2 April 2024, that they now recognize marketing approvals for Class II, III, and IV medical devices issued by Singapore's Health Sciences Authority (HSA) This means manufacturers with existing HSA approvals can now use them to support their applications for registration in Hong Kong, potentially saving significant time and resources.

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HONG KONG: Keeping Up with the MDACS - The Exclusion of Particular Devices and HSA Marketing Approval Acceptance – June/July 2024

HONG KONG: Keeping Up with the MDACS - The Exclusion of Particular Devices and HSA Marketing Approval Acceptance – June/July 2024

  • 2024-06-19 06:31:24

Starting 13 May 2024, Hong Kong Medical Device Division has excluded non-clinical devices from Medical Device Administrative Control System’s scope. Custom-made medical devices have also been excluded from this scope since 2 April 2024, and marketing approvals from Health Sciences Authority - Singapore has been accepted to support listing applications.

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HONG KONG: A COMPREHENSIVE GUIDE TO THE NEW MD111 SUPPLEMENTARY INFORMATION SHEET– MARCH/APRIL 2024

HONG KONG: A COMPREHENSIVE GUIDE TO THE NEW MD111 SUPPLEMENTARY INFORMATION SHEET– MARCH/APRIL 2024

  • 2024-04-08 07:44:40

Last February 19, 2024, Hong Kong Medical Device Division has published a Supplementary Information Sheet (MD111) to strengthen procurement strategy with the Hospital Authority (HA). HA procured devices seeking to be listed under Medical Device Administrative Control System can provide supplementary information through this form for regulatory authorities’ consideration.

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