[Home](/)/[Resources](/resources)/Hong Kong Medical Device Listing Hong KongGlobalRegulation guide # Hong Kong Medical Device Listing (MDACS) Hong Kong's Medical Device Administrative Control System (MDACS) is, for now, a voluntary listing regime run by the Medical Device Division — not a statutory registration law. That's set to change: the Government has committed to a 2026 legislative proposal for mandatory registration alongside a new Centre for Medical Products Regulation, making today's voluntary listing a strategic head start rather than an optional formality. Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Fhong-kong-medical-device-listing) At a glance Regulator MDD (formerly MDCO) Regime Voluntary (statutory in 2026) Coverage Gen. Class II-IV, IVD Class B-D Live database mdd.gov.hk ## What structures the Hong Kong medical device route ### MDACS is voluntary today The Medical Device Administrative Control System, run by the Medical Device Division (MDD, formerly the Medical Device Control Office), is a voluntary/administrative listing regime — not yet a statutory registration requirement. It covers general device Classes II–IV and IVD Classes B–D. ### Statutory transition is coming in 2026 The Government's 2025 Policy Address confirmed a legislative proposal for statutory medical device registration will go to the Legislative Council in 2026, alongside establishing the new Hong Kong Centre for Medical Products Regulation (CMPR). Mandatory registration is prospective, not yet in force. ### Live, searchable registries already exist MDD operates the Medical Device Information System (MDIS, launched April 2024), with live search databases for Medical Devices, Local Responsible Persons, Importers, Distributors, Local Manufacturers, and Conformity Assessment Bodies (CABs) — all searchable at mdd.gov.hk. ### The old domain names no longer work The office previously operated as the Medical Device Control Office at mdco.gov.hk/mdc.gov.hk — those domains no longer resolve. The current office is the Medical Device Division at mdd.gov.hk. ## Listing workflow 01 Classify the device: general medical device Class I–IV, or IVD Class A–D — MDACS listing currently covers general Classes II–IV and IVD Classes B–D. 02 Prepare technical documentation supporting the device's safety and performance claims, analogous to a technical file for other markets. 03 Verify your Conformity Assessment Body against MDD's live CAB search database before relying on any claimed certification. 04 Apply for MDACS listing through the Medical Device Division. 05 Once listed, the device, its Local Responsible Person, importer, and distributor all appear in the public, searchable MDIS databases. 06 Monitor the 2026 statutory transition and the standing-up of the Centre for Medical Products Regulation — early voluntary listing today positions you ahead of the mandatory regime. ## Frequently asked questions ### Is MDACS listing legally required to sell a medical device in Hong Kong? Not yet. MDACS is currently voluntary and administrative rather than a statutory legal requirement. That said, public reporting suggests devices procured by the Department of Health may face earlier mandatory listing timelines, and the Government has committed to a 2026 legislative proposal for full statutory registration — voluntary listing now is a reasonable hedge against that transition. ### What happened to the Medical Device Control Office (MDCO)? It was renamed and relocated online as the Medical Device Division (MDD). The old mdco.gov.hk and mdc.gov.hk domains no longer resolve — the current official site and search databases are at mdd.gov.hk. ### How do I verify a Conformity Assessment Body is legitimately recognized? MDD publishes a live, searchable CAB database (searchable by CAB name or certificate number) at mdd.gov.hk/en/mdacs/search-database/list-cab/, listing certificate number, name, address, phone, and scope of recognition. Check any claimed CAB against this database directly rather than relying on a CAB's own representation. ### What is the Hong Kong Centre for Medical Products Regulation (CMPR)? It's a new regulatory body the Hong Kong Government committed to establishing, announced in the 2025 Policy Address, that will stand up alongside the 2026 statutory medical device registration legislation. It's expected to take on the statutory oversight role that MDACS's voluntary framework doesn't currently have. **Disclaimer:** Educational resource only. Regulatory requirements change and vary by product category. Consult an accredited test laboratory or qualified compliance engineer before making certification decisions. 🇭🇰 Hong Kong roadmap for your product Every standard, document, and test that applies — free, no account required. See your free roadmap[ Want an expert to take your product through 🇭🇰 Hong Kong compliance for you? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. See compliance services](/services) Learn this properly In-depth course that teaches the full process, not just this one answer. [Start the course — $199](/courses/50-hong-kong-medical-device-registration-mdacs-statutory-cmpr)[Prefer to read? 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