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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?
 
Would regulation limit the choice of medical devices available in the market?
 
What is the progress on the regulation of medical devices so far?
 
Do overseas countries have regulation on medical devices?
 
What is the International Medical Device Regulators Forum?
 
   
Classification of medical devices
   
 
How many classes of medical devices are there?
 
What are the principles in classifying general medical devices and in vitro diagnostic 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 Medical Device Classification Program
 
Web-based In Vitro Diagnostic Medical Device Classification Programme
 
   
Medical Device Administrative Control System
   
 
What is Medical Device Administrative Control System?
 
How to become a local responsible person, a local manufacturer, an importer or a distributor of medical devices under the Medical Device Administrative Control System?
 
How to submit change application to the Department of Health in regard to the listed medical devices or listed traders?
 
What are delisted medical devices? Under what circumstances will a medical device be delisted?
 
What is a Conformity Assessment Body?
 
   
Medical Device Adverse Incident and Field Safety Corrective Action
   
 
What is a reportable medical device adverse incident?
 
What actions will the Department of Health take upon receiving reports of medical device adverse incidents?
 
What is a Field Safety Corrective Action?
 
What are the responsibilities of the local responsible person in relation to product alerts, modifications and recalls issued by overseas authorities or the manufacturer?
 
   
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 having a medical purpose(s), 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 disease 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 categorised 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 medical device under the Medical Device Administrative Control System.

For more details, please refer to the full definition of medical device recommended by the International Medical Device Regulators Forum (IMDRF).

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What is the existing legislative control of medical devices?
 

Currently, there is no specific legislation that regulates the manufacture, import, export and sale 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), and the Telecommunications Ordinance (Cap 106).

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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, performance 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 of medical device in Hong Kong.

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Would 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 device. Therefore, we propose a cost-effective, risk-based regulatory approach with reference to harmonised international standards recommended by the relevant international authority – International Medical Device Regulators Forum (IMDRF). The degree of control will be relative to the level of risk associated with a device.

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What is the progress on the regulation of medical devices 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 familiarise themselves with the future mandatory requirements, the Government has launched the voluntary Medical Device Administrative Control System (MDACS) since November 2004. The listing of medical devices and traders, and the Conformity Assessment Body (CAB) Recognition Scheme were implemented in phases. The MDACS covers Classes II to IV (medium to high risk) general medical devices, Classes B to D (medium to high risk) in vitro diagnostic medical devices, local manufacturers, importers, distributors and CABs. The MDACS has the same scope as that of the proposed legislative control framework. Information on the listed medical devices and listed traders can be found on our website.

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Do overseas countries have regulation on medical devices?
 

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

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What is International Medical Device Regulators Forum?
 

International Medical Device Regulators Forum (IMRDF) (previously Global Harmonization Task Force (GHTF)) is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundation work of the GHTF, and to accelerate international medical device regulatory harmonisation and convergence. IMDRF members include Australia, Brazil, Canada, China, European Union, Japan, Russia, Singapore, South Korea and the United States of America.

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

Taking reference from the Principles of Medical Devices Classification proposed by the International Medical Device Regulators Forum (IMDRF), medical devices (including general medical device and in vitro diagnostic medical devices (IVDMDs) are grouped into four (4) classes according to the risk level associated with their intended use. Class IV general medical devices / Class D IVDMDs bear the highest risk whereas Class I general medical devices / Class A IVDMDs bear the lowest risk.

Please refer to the Classification Rules of Medical Devices and Principles of In Vitro Diagnostic Medical Devices Classification for details.

Some examples of classified general medical devices and some examples of classificed in vitro diagnostic medical devices can also be found on our website (please note that the listed examples are for the purpose of illustration only. The classification of a particular general medical device or IVDMD 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 general medical devices and in vitro diagnostic medical devices?
 

Medical devices are classified according to the risk level associated with their intended use. In general, the risk level of a medical device depends on its design as well as intended use.

For general medical devices, the actual classification of each device 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 in vitro diagnostic medical devices, the actual classification of each device depends on the following factors, such as the expertise of intended user, importance of the information to the diagnosis and the impact of the result to the individual and to public health.

For details, please refer to Classification Rules of Medical Devices and Principles of In Vitro Diagnostic Medical Devices Classification .

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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 or Principles of In Vitro Diagnostic Medical Devices Classification and provide this information.

Some examples of classified general medical devices and some examples of classified in vitro diagnostic medical devices can also be found on our website (please note that the listed examples are for the purpose of illustration only. The classification of a particular general medical device or in vitro diagnostic medical devices depends on its actual design, intended use, and other factors).

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  Medical Device Administrative Control System
   
What is Medical Device Administrative Control System?
 

Medical Device Administrative Control System (MDACS) is a voluntary system established by the Department of Health in 2004 to pave the way for implementing the long-term statutory control of medical devices. The MDACS consists of a number of control measures, including the listing system for medical devices and traders, as well as medical device adverse incidents reporting.

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How to become a local responsible person, a local manufacturer, an importer or a distributor of medical devices under the Medical Device Administrative Control System?
 

Applicants for listing of local responsible person, local manufacturer, importer or distributor could download application form from our website and submit a completed application form together with the following documentations to the Department of Health:

1. Local Responsible Person

  • Valid Business Registration Certificate
  • Designation Letter issued by the manufacturer
  • Set of documented procedures

The application for the inclusion on the List of LRP has to be made together with the general medical device or in vitro diagnostic medical device listing application. For details, please refer to Overview of the Medical Device Administrative Control System.

2. Local Manufacturer

  • Valid Business Registration Certificate
  • Certified Quality Management System, e.g. ISO 13485
  • Set of documented procedures
  • List of medical devices manufactured

For details, please refer to Guidance Notes for Listing of Local Manufacturers.

3. Importer or Distributor

  • Valid Business Registration Certificate
  • List of medical devices imported or distributed
  • Set of documented procedures

For details, please refer to Guidance Notes for Listing of Importers of Medical Devices and Guidance Notes for Listing of Distributors.

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How to submit change application to the Department of Health in regard to the listed medical devices or listed traders?
 

When there is any change to the information that has been submitted in relation to a listing, e.g. change of trader’s address, change of model number, change of device design, the local responsible person or trader shall notify the Department of Health as soon as possible.

The change application form could be downloaded from our website.

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What are delisted medical devices? Under what circumstances will medical device be delisted?
 

Delisted medical device means a medical device to be removed permanently or temporarily from “The List of Medical Devices” at the discretion of the Department of Health (DH), where any of the following circumstances arises –

  1. The DH considers the delisting necessary for public health or safety considerations, e.g. the manufacturer or the local responsible person (LRP) fails to address or to adequately address a hazard of the device; or
  2. The manufacturer or the LRP fails to comply with the requirements of the Medical Device Administrative Control System or any of the listing conditions; or
  3. The manufacturer or the LRP fails to comply with an instruction from the DH to withdraw an unjustified claim in an advertisement for the medical device; or
  4. The manufacturer or the LRP has been wound up or has ceased to exist; or
  5. The delisting is requested by the manufacturer or the LRP.

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What is a Conformity Assessment Body?
 

A Conformity Assessment Body (CAB) is a body recognised by the Department of Health (DH) to engage in the conformity assessment of the medical device or the trader’s quality management system for determining whether the relevant Medical Device Administrative Control System requirements are fulfilled. The list of Confirmity Assessment Bodies recognised by the Department of Health could be found from our website.

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  Medical Device Adverse Incident and Field Safety Corrective Action
   
What is a reportable medical device adverse incident?
 

Any incident that meets all of the following three basic criteria is considered a reportable adverse incident:

  1. The local responsible person (LRP) becomes aware of information regarding an incident that has occurred with his listed device(s);
  2. The LRP’s device is associated with the incident; and
  3. The incident led to one of the following outcomes:
    • Death of a patient, user or other person; or
    • Serious injury of a patient, user or other person; or
    • No death or serious injury occurred, but the incident might lead to death or serious injury of a patient, user or other person if the incident recurs.

    Note: In assessing the link between the device and the incident, the LRP should take into account:

    • The opinion, based on available information, from a healthcare professional; and
    • Information concerning previous similar incidents; and
    • Other information held by the LRP or the manufacturer.

Please note that incidents occurring outside Hong Kong do NOT need to be reported. For details, please refer to Guidance Notes for Adverse Incident Reporting by Local Responsible Persons.

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What actions will the Department of Health take upon receiving reports of medical device adverse incidents?
 

The Department of Health (DH) will closely monitor the investigation done by the local supplier and the manufacturer. The investigation reports may reveal unexpected problems related to the medical device, which can lead to actions including but not limited to product recall, revision of user manual, and device modification. The DH will monitor the corrective and preventive actions that are being implemented to prevent similar events from recurring.

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What is a Field Safety Corrective Action?
 

Field Safety Corrective Action means corrective action taken by the manufacturer for technical or medical reasons to prevent from or reduce the risk of a serious incident in relation to a device made available on the market. This may include:

  1. The return of a medical device to the manufacturer or its representative;
  2. Device modification;
  3. Device replacement;
  4. Device disposal; or
  5. Advice given by manufacturer regarding the use of the device.

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What are the responsibilities of the local responsible person in relation to product alerts, modifications and recalls issued by overseas authorities or the manufacturer?
 

Upon the issuance of alerts, modification notices and recalls by the manufacturer or overseas authorities, the local responsible person (LRP) shall inform the Department of Health (DH) of the related details (e.g. whether the affected products are supplied in Hong Kong) and actions to be taken in Hong Kong as soon as possible, and not later than 10 calendar days after their issuance. The LRP shall follow up the actions, and shall submit progress reports to the DH as requested until the case is concluded. It is preferred that prior arrangements be made such that within four hours of the issuance of an alert, recall or modification notice by the manufacturer, the same be also e-mailed direct to the DH.

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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. Manufacturers and traders should also take into consideration the relevant requirements and regulations of the institution where the clinical trial is to be implemented.

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Last Revision Date: 20 September 2019