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Frequently Asked Questions

General
   
 
What is a medical device?
 
What is the existing legislative control of medical devices?
 
Why do we need to regulate medical devices?
 
Does regulation limit the choice of medical devices available in the market?
 
What is the progress so far?
 
Do overseas countries have regulation on medical devices?
 
What is the Global Harmonization Task Force (GHTF)?
 
   
Classification of medical devices
   
 
How many classes of medical devices are there?
 
What are the principles in classifying medical devices?
 
What is the purpose of separating medical devices into different classes?
 
How can I know the class of a particular medical device?
 
Web-based General Medical Device Classification Programme
 
Web-based In Vitro Diagnostic Medical Device Classification Programme
 
   
Control on use of selected medical devices
   
 
What is the proposed control on use of medical devices?
 
   
Others
   
 
What is the existing legislative control of clinical trial of medical devices?
 
   
   
  General
   
What is a medical device?
 

Medical devices generally refer to products which have a medical purpose, and range from sophisticated equipment such as cardiac pacemakers used by health care professionals to simple products such as bandages and thermometers bought over the counter by the public.

In essence, a medical device refers to any instrument, apparatus, appliance, material or other article, excluding drugs, used for human beings for diagnosis, prevention, treatment, monitoring of diseases or injuries; or for rehabilitation purposes; or for the purposes of investigation, replacement or modification of body structure or function. In addition, it includes devices used for examination of human specimens for the purposes of diagnostic, monitoring and compatibility in the forms of reagents, calibrators, control materials, specimen receptacles etc. which are categorized under in vitro diagnostic medical devices.

An accessory to a medical device is subject to the same regulations that apply to the medical device itself. However, devices designed for the treatment or diagnosis of diseases and injuries in animals are outside the scope of the proposed regulatory framework.

Please refer here for a full definition of medical device as adopted from the International Medical Device Regulators Forum (IMDRF) (previously Global Harmonization Task Force (GHTF)).

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What is the existing legislative control of medical devices?
 

Currently, there is no overarching legislation that regulates the manufacture, import, export, sale and use of medical devices in Hong Kong. However, depending on the nature and characteristics of the products concerned, some products may be regulated by existing pieces of legislation such as the Pharmacy and Poisons Ordinance (Cap 138), the Radiation Ordinance (Cap 303), the Telecommunications Ordinance (Cap 106), etc.

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Why do we need to regulate medical devices?
 

Following are the major problems identified at present -

  1. No pre-market control to assess the safety, efficacy and quality of medical devices to safeguard public health;

  2. No formal post-market surveillance system including adverse incident reporting; and

  3. Inadequate product information for the public and operators to make informed choices on the safe use of medical devices.

In view of the above, there is a need to develop an appropriate regulatory system to control the supply and use of medical devices in Hong Kong.

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Does regulation limit the choice of medical devices available in the market?
 

We should strike a balance between providing consumers with sufficient choice and offering the community medical devices that perform safely, efficaciously and as intended. The Government is aware of the potential cost implication to the trade and users of medical devices. Therefore, we propose a cost-effective, risk-based regulatory approach with reference to harmonized international standards recommended by the relevant international authority - IMDRF (previously GHTF). The degree of control will be relative to the level of risk associated with a device.

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What is the progress so far?
 

A statutory control framework for medical devices is being developed by the government to ensure that medical devices are safe, of good quality, and can perform as intended before they are allowed to be placed on the local market. To raise public awareness on the safe use of medical devices and enable traders to familiarize themselves with the future mandatory requirements, the Government launched a Medical Device Administrative Control System (MDACS) on 26 November 2004. The first phase of MDACS starts with voluntary listing of Class IV (High Risk) Medical Devices. The second phase of MDACS, which includes voluntary listing of Class II & Class III (Medium Risk) Medical Devices, has been launched on 14 November 2005. Subsequently, listing of local manufacturers, importers, distributors, Class B, Class C and Class D IVD medical devices as well as recognition scheme for CABs were also launched. Information on the listed medical devices and traders are posted on our website.

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Do overseas countries have regulation on medical devices?
 

Many regions and countries like the European Union, USA, Australia, Canada, and Japan already have their own systems for the control of medical devices. Asia-Pacific countries such as the Mainland China, the Philippines, Indonesia, South Korea, Thailand, Singapore and Malaysia also operate their own systems to regulate medical devices.

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What is the Global Harmonization Task Force (GHTF)?
 

GHTF is a voluntary consortium with representatives from the trade and regulatory authorities from USA, Canada, Australia, Japan and the European Union formed in 1992 to harmonize the standards and principles of regulating medical devices. In 2011, GHTF is disbanded, and a new regulator-led group known as International Medical Device Regulators Forum (IMDRF) is formed to build on the foundational work of GHTF and aims to accelerate international medical device regulatory harmonization and convergence.

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  Classification of medical devices
   
How many classes of medical devices are there?
 

Adopting from the Principles of Medical Devices Classification proposed by the IMDRF (previously GHTF), medical devices are grouped into four (4) classes according to the risk level associated with their intended use. Class IV Medical Devices bear the highest risk whereas Class I Devices bear the lowest risk. Please refer to the Classification Rules of Medical Devices for details. Some general examples of classified devices can also be found in our website (please note that the listed examples are for the purpose of illustration only. The classification of a particular medical device depends on its actual design, intended use, and other factors described in the following question).

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What are the principles in classifying medical devices?
 

Medical devices are classified according to the risk level associated with their intended use. In general, the risk level depends on the design of a medical device as well as its intended use. The actual classification of each device also depends on one or several of the following factors, such as the duration of device in contact with the body, the degree of invasiveness, whether the device delivers medicines or energy to the patient, whether they are intended to have a biological effect on the patient and local versus systematic effects (e.g. conventional versus absorbable sutures). These factors may, alone or in combination, affect device classification. For details, please refer to Classification Rules of Medical Devices.

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What is the purpose of separating medical devices into different classes?
 

Safety can only be considered in relative terms. All medical devices carry a certain degree of risk that could cause problems in specific circumstances. The level of regulatory control should take into account the risks and benefits associated with use of the medical device. To avoid unnecessary burden on trade and provide local consumers with access to medical devices of latest technology, the rules of classification separate medical devices into different classes and subject them to different level of regulatory control.

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How can I know the class of a particular medical device?
 

The class of a particular medical device is important for the purpose of regulatory control, such as a decision on whether pre-market approval and/or post-market surveillance are required. As classification of a particular medical device depends on the risk associated with its intended purpose, the manufacturer is in the best position to follow the Classification Rules of Medical Devices and provide this information. Some general examples of classified devices can also be found in our website.

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  Control on use of selected medical devices
   
What is the proposed control on use of medical devices?
 

There are calls for controls over the use of selected medical devices, which, if operated by unqualified personnel, may cause injuries or harm to patients or the operators. Such devices include those adopted for use by the beauty industry (e.g. high power lasers). The government will take into account of public concern and risk assessment when considering whether controls should be implemented over the use of medical devices under the proposed legislation.

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  Others
   
What is the existing legislative control of clinical trial of medical devices?
 

Currently there is no specific legislation to regulate clinical trial of medical devices in Hong Kong. However, depending on the nature of the devices concerned, they may be subject to regulatory control of existing legislations. Yet, manufacturers and traders should also take into consideration of the relevant requirements and regulations of the institution where the clinical trial is to be implemented.

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Last Revision Date: 26 April 2019