Hong Kong Medical Device Division (MDD)

Medical Device registration in Hong Kong is managed by the Medical Device Division (MDD) of the Department of Health, formerly known as the Medical Device Control Office (MDCO). The MDD is located in Taikoo Shing, Hong Kong and serves as the national regulatory body and competent authority for the country.

Over the years, several different changes have been made in order to streamline the regulatory process and ensure effective control. For instance, the MDCO introduced the Medical Device Administrative Control System (MDACS) in 1995. This electronic system facilitated the submission and processing of applications for medical device registration, import licensing, and amendment requests.

Later the MDCO was restructured and transformed into the Medical Device Division (MDD) under the Pharmacy and Poisons Board (PPB). The transition aimed to strengthen the regulation of medical devices by integrating it into the broader framework of pharmaceutical and poisons control. The MDD became the central authority responsible for licensing, registration, and surveillance of medical devices in Hong Kong.

Significant Recent Hong Kong MDD Regulatory Updates

Several regulatory updates have been made over recent years in order to ensure the Hong Kong MDD stays up to date with worldwide regulatory trends. The MDD has sought to incorporate international best practices and standards into its regulatory framework, leading to cooperation with organizations such as the International Medical Device Regulators Forum (IMDRF) and the World Health Organization (WHO) has facilitated knowledge sharing.

Another significant recent regulatory update from the MDD arrived in January 2022, the Expedited Approval Scheme. Previously a trial scheme, this regulatory update provided qualifying Class II, III, and IV applications with a quicker review process. Read more about this from our blog on the subject here.

In order to be eligible for this Expedited Approval process, the products in question must have 2 Reference Country approvals, no serious adverse events and no currently ongoing adverse events. Approved Reference Countries include the US, Canada, Europe, Australia, Japan, China, and Korea. The MDD’s formal guidance can be found here under GN-02.

Recent Blogs on Hong Kong

Hong Kong Refines Medical Device Post-Market Surveillance Report

Hong Kong to Pilot Prioritizing Some Listed Medical Devices

Hong Kong’s MDD Formalizes the Expedited Approval Scheme

Hong Kong Medical Device Regulations and Important Links

Guidance Notes for Listing Class II/III/IV General Medical Devices

Scheme for Expedited Approval of Class II/III/IV Medical Device Listing Applications

MDD Device Listing Application

List of MDD Forms

More Information on Hong Kong Regulatory Requirements for Medical Devices

Hong Kong Medical Device Division Home Page

Medical Device Administrative Control System Activities/Notifications

Issued Documents Under Medical Device Administrative Control System (MDACS)

Asia Actual’s Hong Kong Medical Device Regulatory Overview Page

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Contact Asia Actual if you have any questions and/or would like to learn more about accessing the Hong Kong market specific to your product portfolio.

Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.