Author: Jenny Lin, Senior Manager, Medical Devices / IVD, Australia
The voluntary Medical Device Administrative Control System (MDACS) has been in place in Hong Kong since 2004 in preparation for future enactment into legislation. Whilst it is currently not a mandatory requirement for medical devices to be listed with the MDACS, those included under the system are more likely to be successful in the public tender process than their non-listed counterparts in the public sector. This matters because more than 70% of healthcare facilities in Hong Kong are public institutions, which are managed through the Health Authority under the Department of Health (DH).
Effective from 1 October 2022, the DH in Hong Kong has started a pilot run which includes a new requirement in the quotation and tender process that certain medical devices being purchased by the DH should preferably be listed under MDACS.
These devices are:
- condoms
- lubricants of class II or above
- blood glucose meters
- blood glucose strips
Under the procurement requirements, preference will be given for MDs listed under the MDACS. Preference will also be given in the quotation for listed MDs.
Depending on the experience gained from this pilot run, DH may extend the new requirement to other devices. MD manufacturers are encouraged to list their devices as soon as possible to secure a spot in the procurement process and to avoid a potentially long wait time should the scheme expand to a broader scope of devices.
If you have any questions or need assistance with Hong Kong registration, be sure to reach out to the PharmaLex team for a no-obligation discussion.
