The Department of Health (DH) in Hong Kong has announced a new strategy for the procurement of medical devices (MDs), effective from June 21, 2023.
A list of recently updated articles regarding medical device regulatory updates from the MDD and other governing bodies in Hong Kong.
In addition to receiving market authorization for the safety and efficacy of their product, manufacturers wishing to advertise their medical devices, especially Direct to Consumer, may need to also obtain approval for their marketing material.
As manufacturers finish transitioning to the new EU MDR requirements, it will be important to understand the implications of these changes on existing licenses around the world.
On December 29th, 2022, the Hong Kong Medical Device Division refined and updated their Post-Market Surveillance Report form.
Hong Kong’s MDD announced the start of a pilot program that will give preference to MDACS listed medical devices.
Manufacturers looking to Southeast Asia to help grow their medical device sales will need to become familiar with the Common Submission Dossier Template, or “CSDT.”
Hong Kong’s Expedited Approval Scheme has been upgraded from a trial. Approvals from at least 2 GHTF countries plus China.
Medical device manufacturers that are serious about growing sales in Hong Kong/Southeast Asia should consider registration a mandatory step.
By allowing manufacturers to show conformity to the MDD’s assessment requirements by using NMPA or MFDS approvals, Chinese and Korean manufacturers would save 6-9 months during the application process.
COVID-19 impacts medical device shipment logistics. Manufacturers will need to adapt their supply chain in order to meet demands and lower costs.