Hong Kong’s Proposed Medical Device Regulations

Hong Kong’s Proposed Medical Device Regulations

With a per capita gross domestic product (GDP) of $43,000, Hong Kong is among the highest in Asia, following Singapore and Brunei. Compared with other parts of the world, Hong Kong’s per capita GDP is not far off from that of the United States (about $46,000) or Switzerland (about $44,000).

While there are no official statistics, we estimate Hong Kong’s medical device market value at approximately $600 million. This is approximately one-fifth the size of India’s $2.7 billion medical device market. Of course, Hong Kong’s population is only 7 million people compared with India’s 1.2 billion. Furthermore, most of the medical devices in Hong Kong are imported. The diseases and medical conditions that affect Hong Kong’s populations overlap significantly with those of the United States and Western Europe.

Although Hong Kong is a part of China, its status as a special administrative region allows for a significant amount of autonomy. In terms of medical device regulations, Hong Kong has its own set of unique medical device regulations that are different from those of China. In 2004, Hong Kong created the Medical Device Control Office as a part of the Department of Health to govern issues related to medical devices. The same year, the newly created agency released the voluntary Medical Device Administrative Control System (MDACS) for the public to become familiar with regulations that were being developed.

In late August this year, Hong Kong’s Medical Device Control Office proposed its framework for comprehensive and mandatory regulation of medical devices and in-vitro diagnostic medical devices. There are many similarities to the MDACS of 2004. As with the MDACS, the new framework significantly draws from the Global Harmonization Task Force (GHTF) and the World Health Organization. Hong Kong’s proposed medical device regulations framework is divided into five sections:

1. Definitions and Classification
2. Premarket Control
3. Postmarket Control
4. Use Control
5. Import/Export Control

This column provides an overview of the details that have been released thus far.

Definition and Classification of Medical Devices

As previously reported, Hong Kong’s proposed system will align with the GHTF for medical device definition and classification. The definition of a medical device is the same as the GHTF’s broad definition: “any instrument […] for human beings for one or more of the specific purpose(s) of (1) diagnosis, prevention, monitoring, treatment or alleviation of disease…”

Likewise, the medical device classifications also are the same as those of the GHTF. Specifically, medical devices will be classified into Classes I, II, III and IV based on risk levels (where Class I is the lowest risk and Class IV is the highest risk).

Examples include:

• Class I (low risk): tongue depressors, bandages, surgical masks, wheelchairs;

• Class II (medium-low risk): hypodermic syringes, contact lenses, endoscopes;

• Class III (medium-high risk): X-ray machines, condoms, orthopedic implants; and

• Class IV (high risk): implantable cardiac pacemakers, breast implants.

For in-vitro diagnostic medical devices, there will be Classes A, B, C and D (where Class A is the lowest risk and Class D is the highest risk).

Examples include:
• Class A (low individual risk and low public risk): clinical chemistry analyzers, culture media;

• Class B (medium individual risk and low public risk): pregnancy self tests, urine test strips;

• Class C (high individual risk and medium public risk): blood glucose self tests, human leukocyte antigen typing; and

• Class D (high individual risk and high public risk): HIV diagnostic tests.

Premarket Control

Registration of Medical Devices

Before medical devices can be sold in Hong Kong’s market, they will need to be registered with Hong Kong’s Department of Health (most likely through the Medical Device Control Office). The registration process and details have not been released, but the goal is maintenance of safety, performance and quality. Registration for medical devices will be carried out in phases.

Authorized Representatives

In contrast to the name “Local Representative Person” in Hong Kong’s 2004 MDACS, the latest proposal refers to the person serving in this role as an Authorized Representative (AR). The AR—appointed by the overseas or local manufacturer—will foster communication among medical device manufacturers, importers/exporters, distributors and regulatory officials. Similar to medical devices, representatives will need to be registered with the Department of Health.

Local Manufacturers

Local manufacturers also will need to register with the Department of Health. Manufacturers must have in place a quality management system that complies with ISO 13485 or another similar standard. Regulatory officials may conduct routine checks to confirm compliance.

Importers/Exporters

To improve the traceability, importers and exporters also will be required to register with the Department of Health.

Distributors

In Hong Kong, “distributors” will be defined as “traders who sell medical devices for the purpose of resale or use, other than for personal use.” As a part of the medical device regulation proposal, distributors will need to be registered with the Department of Health. This clause also aims to improve the traceability of medical devices.

Conformity Assessment Bodies

To aid in implementing these upcoming medical device regulations, Hong Kong plans to allow for Conformity Assessment Bodies (CABs). CABs will be regulatory bodies (usually independent of the government) that will be involved in the registration process for those mentioned above. These CABs, though, also must be registered with Hong Kong’s Department of Health before they can assume registration assessment duties.

Postmarket Control

Authorized Representatives and manufacturers will have significant responsibilities for postmarket control.

Proactive Surveillance

ARs must implement a tracking system that can locate specific high-risk devices. For example, a regulatory official may expect an AR to provide information for where an artificial heart valve was sent. After, there may be a requirement for ARs to compile surveillance reports to be submitted to regulatory officials upon request. Manufacturers are expected to assist ARs with these duties.

Adverse Event Reporting & Investigation

Manufacturers and ARs will be required to report and investigate adverse events and execute plans to resolve any related issues. Regulatory authorities are charged with making sure that these entities are properly performing these duties.

Warning, recall, forfeiture and disposal

Regulatory officials can release warnings, recalls, forfeitures and disposal directives on unsafe medical devices. ARs and manufacturers are accountable for complying with any of these directives.

Use Control

Hong Kong’s proposed regulations also attempt to ensure that non-medical professionals use medical devices appropriately. Persons who operate high-risk devices, such as high-power lasers, also will need to apply for a license.

Import/Export Use

Detailed explanations have not been released, but Hong Kong’s latest update suggests that particularly high-risk devices also may require their own import/export license. The Medical Device Control Office currently is seeking public comments on this idea.

Hong Kong’s government currently does not strictly regulate most medical devices. However, this latest proposal is a clear sign that legislation for control of medical devices soon will appear. Companies doing business in Hong Kong should begin preparations for these upcoming regulations.

Ames Gross is president and founder of Pacific Bridge Medical, a Bethesda, Md.-based
consulting firm that helps medical technology companies doing business in the Asia market
(www.pacificbridgemedical.com). A recognized national and international leader in the Asian medical markets, he founded Pacific Bridge Medical in 1988, which has helped hundreds of medical companies with business development and regulatory issues in Asia.

Arthur Chyan is an associate with Pacific Bridge Medical. He is fluent in Chinese and Japanese and works on consulting projects and conducting research.