Is MDACS listing mandatory for selling in Hong Kong?
The system is transitioning from voluntary to mandatory. What is already firm: since 23 March 2026, devices procured by the Department of Health (Class II–IV general, Class B–D IVD) must hold a valid MDACS listing to be eligible for tenders and quotations. A legislative proposal for a full statutory regime, with a new Centre for Medical Products Regulation, is in progress. Early voluntary listing is a strategic head start.
What does an LRP do — and do we need one?
If you are an overseas manufacturer listing a device under MDACS, you need a Local Responsible Person in Hong Kong. The LRP carries statutory duties: adverse event reporting, vigilance, record-keeping, recall coordination and liaison with the Department of Health. We act as LRP for overseas manufacturers, which lets you serve the market without incorporating locally.
We are a mainland Chinese manufacturer. Can you help us go outbound?
Yes — that is one half of our practice. We advise on structuring Hong Kong operations, obtaining recognised certifications to support other markets, and using Hong Kong as a launchpad for international registration, alongside MDACS listing for the local market.
How do we start, and what does it cost?
Start with a free 30-minute scoping call. After that you receive a written pathway assessment with a fixed-fee quotation before any commitment — no hourly billing surprises. Use the contact section below to book.