Hong Kong’s Medical Device Control Office and Department of Health

1. Overview

In Hong Kong, the oversight of medical devices falls under the jurisdiction of the Medical Device Control Office (MDCO). It is tasked with regulating and ensuring compliance with standards for medical devices within the territory. Similarly, the Department of Health in Hong Kong is responsible for monitoring the safety, effectiveness, and quality of all pharmaceuticals available in the market.

2. Hong Kong Medical Device registration with the Medical Device Control Office

Medical devices in Hong Kong are classified based on their risk levels, progressing from the lowest-risk to the highest-risk – Class I, Class II, Class III, and Class IV. Hong Kong’s Medical Device Control Office (MDCO) offers an online tool for determining the classification of medical devices.

Hong Kong has still not promulgated final device registration requirements. However, device companies are encouraged to register their products on the voluntary registration list now to be first in line when formal device registration is required. Also, Hong Kong hospitals prefer buying devices on the voluntary registration list.

A local, licensed business entity, known as a Local Responsible Person (LRP), is required to submit registration applications for medical devices (voluntary registration list). The LRP holds post-market vigilance responsibilities for both registered medical devices and those undergoing the application review process.

The official processing time for medical device applications is 3-9 months, but delays for new risky devices can extend the application review period from 12-18 months. Approved device applications on the voluntary registration list receive a listing number and are included in the online database, with listings valid for 5 years.

Since 2019, the Chinese government has permitted Hong Kong-listed medical devices to be sold to some Chinese medical institutions within the Greater Bay Area (GBA). The GBA, with a population of about 90 million people, serves as a prominent economic and business center connecting Hong Kong and Macau with nine cities in Southern China.

3. Hong Kong Pharmaceutical Registration with the Department of Health

Hong Kong’s pharmaceutical laws mandate that medicines undergo registration with the Pharmacy and Poisons Board (PPB) before sale, categorized as follows:

Category 1: Prescription medicines like antihypertensives require a doctor’s prescription for dispensing in registered pharmacies under pharmacist supervision. The label “Prescription Drug” is required.

Category 2: Non-prescription medicines, like certain painkillers, do not need a prescription but must be sold under registered pharmacists’ guidance. The label “Drug under Supervised Sales” is necessary.

Category 3: Common medicines like those for colds can be sold without a resident pharmacist. Although side effects are fewer, improper use may lead to complications. Caution and consulting a doctor are advised.

To facilitate registration, the manufacturer must furnish product documents validating its safety, effectiveness, and quality. Typically, these documents include manufacturing and quality control procedures, clinical study reports, and post-marketing study results conducted abroad. If the product is produced outside Hong Kong, the local importer is responsible for securing the registration.

On October 31, the Pharmacy and Poisons Board in Hong Kong was granted “observer status” within the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). This milestone will enhance Hong Kong’s understanding of worldwide drug registration and help the country move closer to having its approval system for pharmaceutical products.