Hong Kong has become a strategic operational hub for medical device companies looking to expand in Asia. MDD Hong Kong medical device registration is voluntary for certain classes of medical devices and IVDs, though a Local Responsible Person is required for foreign manufacturers along with post-market compliance obligations.
Pure Global simplifies the process with AI workflows that accelerate MDD registration, along with local support and representation, all for a flat annual fee.
Hong Kong’s medical devices market will reach $1.11B by 2029 (6.73% CAGR), and the IVD market $303M (3.77% CAGR). Growth is driven by high healthcare investment and an aging population (20% 65+ in 2021, rising to 32% by 2041).
Medical devices sold in Hong Kong are regulated by the Medical Device Division (MDD). Pure Global can assist with Hong Kong medical device registration and act as your Local Responsible Person (LRP), ensuring MDD approval to sell in the European market.
Medical devices are classified from Class I-IV. IVDs are classified from Class A-D. Understanding the classification of your medical devices is crucial for determining the appropriate regulatory pathway in Hong Kong.
The Department of Health will give preference to all medical devices to be listed under the Medical Device Administrative Control System (MDACS). The voluntary registration system applies to Class II or higher medical devices and Class D IVD products and are encouraged to apply as soon as possible.
Manufacturers without a registered business in Hong Kong must appoint a Local Responsible Person (LRP) to:
We provide turnkey regulatory support in Hong Kong, all for a flat annual fee:
Dossier preparation and submission, powered by AI-assisted workflows and regulatory experts.
In-country representation, with Pure Global serving as your Local Responsible Person.
Post-market surveillance support, including vigilance reporting and authority communications.
Importer authorizations, post-approval modifications, and renewals.
Pure Global offers flat-fee annual pricing for bundled medical device and IVD registration and representation in Hong Kong, starting at $2,000/year. The flat fee includes dossier preparation and submission, in-country representation, translation, modifications, distributor authorization, and post-market support. The fee does not include certified translations or translations from languages other than English.
Flat fee structure for Class I/II devices (Class A/B IVDs):
1 device = $2,000/year
2-5 devices = additional $1,000 per device per year (e.g., 4 devices = $5,000/year)
6-10 devices = additional $500 per device per year (e.g., 8 devices = $7,500/year)
Flat fee structure for Class III/IV devices (Class C/D IVDs):
1 device = $3,000/year
2-5 devices = additional $1,500 per device per year (e.g., 4 devices = $7,500/year)
6-10 devices = additional $1000 per device per year (e.g., 8 devices = $12,000/year)
Contact us for a custom quote if you have 11+ devices.
A three-year contract is required to lock in the fees quoted above. However, other contractual arrangements are available. Use our Fee Calculator for an instant estimate and more information about flat fee terms.
Medical devices in Hong Kong are classified from Class I-IV; IVDs are classified from A-D. Understanding the classification of your device is essential for determining the appropriate regulatory pathway. The voluntary registration system specifically targets Class II or higher medical devices and Class D IVD products.
No, the registration system for medical devices in Hong Kong is voluntary, particularly under the Medical Device Administrative Control System (MDACS). However, the Department of Health encourages the registration of Class II or higher medical devices and Class D IVD products as soon as possible under Hong Kong medical device regulations.
Manufacturers without a registered business in Hong Kong must appoint a Local Responsible Person (LRP). The LRP is responsible for registering the products with the Medical Device Division (MDD Hong Kong) and fulfilling post-market surveillance responsibilities.
When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
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