Voluntary Medical Device Registration in Hong Kong
Hong Kong Medical Device Registration
Medical device registration in Hong Kong is currently voluntary under the MDACS, which was introduced in 2004. The system regulates Classes II to IV (medium to high risk) general medical devices and Classes B to D (medium to high risk) in vitro diagnostic medical devices (IVDs). Class I devices do not require listing.
Manufacturers have two registration pathways to get listed under MDACS:
- Abridged Route
This is for devices already approved in Australia, Canada, the EU, Japan, the U.S., Korea, or mainland China.
- Full Conformity Assessment Route
Requires a complete conformity assessment to demonstrate safety, performance, and compliance with MDACS requirements.
Although listing under MDACS is not mandatory, it can facilitate market entry, particularly for hospitals and clinics. Since October 2022, a pilot program has encouraged procuring certain medical devices, such as blood glucose meters and condoms, from the MDACS listing.
GO-TO-MARKET STRATEGY AND REGISTRATION SUPPORT
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Regulatory Pathways in Hong Kong
Medical Device Regulations Hong Kong
Entering the Hong Kong medical device market requires compliance with the regulatory framework overseen by the Department of Health (DoH). The Medical Device Division (MDD), formerly known as the Medical Device Control Office (MDCO), is responsible for implementing the Medical Device Administrative Control System (MDACS) and developing a long-term regulatory framework for medical devices in Hong Kong.
- Determine device classification based on intended use and risk level.
- Choose a registration pathway (Abridged or Full Conformity Assessment).
- Designate a Local Responsible Person (LRP)
The LRP is the official liaison between manufacturers, users, and the government.
- Prepare application dossier based on MDACS submission guidelines.
- Submit an application to MDD for assessment.
- Evaluation process
MDD reviews the submission and may request additional documents.
- Approval & Listing
After approval, MDD assigns a listing number, and the device is added to the Medical Devices database.
- Market entry & post-market compliance
Manufacturers can begin distribution and must comply with post-market surveillance requirements.
Listing is valid for 5 years; renewal must be applied for at least 3 months before expiry.
Regulatory Compliance in Hong Kong
How Qserve Supports You
Expanding into the Hong Kong medical device market requires strategic planning and compliance expertise. At Qserve, we simplify the Hong Kong Medical Device Registration process, ensuring a smooth market entry.
- Strategic Planning
Tailored market entry strategies based on Hong Kong’s regulatory framework.
- Expert Guidance on MDACS Registration
Ensuring compliance with MDACS and risk classification requirements.
- Global Network & Local Regulatory Support
A strong network of partners providing regulatory and local representation services.
- Proven Experience
Qserve’s regulatory experts have hands-on experience navigating Hong Kong’s medical device registration process.