The Hong Kong Department of Health has implemented a new medical device procurement policy, effective from June 21, 2023. The policy prioritizes Medical Device Administrative Control System (MDACS)-listed medical devices, covering Class II/III/IV general medical devices and Class B/C/D in-vitro diagnostic medical devices.
Manufacturers seeking to supply DH with medical devices are encouraged to list their products under MDACS.
China Med Device summarized customers’ questions raised on the new Hong Kong policy:
What the results from the MDACS filling?
When Department of Health purchases medical devices, whose who listed in MDACS will be given priority to be used by Hong Kong public hospitals.
Any impact on GBA Urgent Use?
One of the prerequisites to enter GBA is that the medical products are being used in Hong Kong and Macau public hospitals.
If already listed in MDACS, do you need to fill again?
Fifth Batches of GBA Urgent Use Devices
Three drugs and five devices as the fifth batch were enrolled to pioneer the clinical use in GBA on September 7, 2023. Below is the devices list:
- Medtronic: Simplicity spray renal denervation catheter
- Medtronic: Simplicity spray renal denervation RF generator
- Cochlear: Cochlear implant with slim modiolar electrode (CI632)
- Cochlear: Kanso sound processor
- Deflux: Injectable gel of hyaluronic acid and dextranomer
Requirements for GBA Policy Application
The Guangdong government released the “Interim Provisions on the Administration of Imported Medicines and Medical Devices in Urgent Clinical Needs in the Guangdong-Hong Kong-Macao Greater Bay Area” on August 27, 2021, finalizing a series of first-of-its-kind measures in China for NMPA unapproved devices.
The document specifies that the medical devices need to meet the below scenarios to be utilized in Guangdong:
- Urgently needed for clinical use.
- Already be used by public hospitals in Hong Kong and Macau.
- Have significant clinical advantage.
- Have not been approved in Mainland China.
- Have unmet medical needs.
The medical institutes need to meet the requirements as follows:
- They can be sole proprietorship, joint venture, or cooperation.
- Obtained medical institution’s practice license.
- Have robust management system in terms of supply, transportation, storage of medical products.
- Have adverse reaction monitoring agency and emergency plans.
Along with the Interim Provisions are the Submission Materials and Review Guideline. Please email us at info@ChinaMedDevice.com to get an English copy.