Expansion on the Expedited Approval Scheme 
The Expedited Approval Scheme for Medical Device Listing Applications has been continued on a regular basis since January 4, 2022, subsequent to the trials of this scheme. However, this Expedited Approval Scheme was previously only open for Class II/III/IV General Medical Device Listing Applications. Effective from July 26, 2024, the "Expedited Approval Scheme for Medical Device Listing Applications" will be expanded to cover Class B/C/D In Vitro Diagnostic (IVD) Medical Device listing applications as well. 

Slight Updates on Requirements
Requirements for applicants eligible to this Expedited Approval Scheme remains the same to the previous requirements for Class II/III/IV General Medical Devices, in which they must comply to 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 regulatory agencies’ approval.

More countries have recently been added to the list of regulatory agencies recognized by MDD under the MDACS, like Singapore and South Korea. The listed countries thus far are as follows:

1. Mainland China (National Medical Products Administration) 
2. Australia (The Therapeutic Goods Administration) 
3. Canada (Health Canada) 
4. Member countries of the European Union that have implemented the European Council Directives or Regulations on medical devices 
5. Japan (Ministry of Health, Labour and Welfare) 
6. Singapore (Health Sciences Authority) 
7. South Korea (Ministry of Food and Drug Safety) 
8. United States of America (U.S. Food and Drug Administration)

The listing application shall now be submitted through Medical Device Information System (MDIS), and the preparation of application form and dossier, should now refer to both Guidance documents for General and IVD Medical Devices:

• -     GN-02: Guidance Notes for Listing Class II/III/IV General Medical Devices
• -     GN-06: Guidance Notes for Listing Class B, C and D In Vitro Diagnostic Medical Devices

 

Connect with Us
With the recent inclusion of Class B/C/D In Vitro Diagnostic Medical Devices, more medical devices are open to the Expedited Approval Scheme for their listing under MDACS. Hong Kong’s Medical Device Division (MDD) may amend or change the terms and conditions of the Scheme from time to time. Our experienced team can guide you through the updated application process, ensuring compliance with new requirements.
 

Qualtech Consulting Corporation has been a trusted partner for medical device manufacturers for over 20 years. Whether you’re a local startup or an international player, we empower your devices to enhance lives. 
Connect with us today here to unlock your medical device potential.

 

 

 

References:

MDD Announcement: The scope of “Expedited Approval Scheme for Medical Device Listing Applications” will extend to include listing application of Class B/C/D In Vitro Diagnostic Medical Device

Notes for the Expedited Approval Scheme for Medical Device Listing Applications (mdd.gov.hk)