Frequently Asked Questions

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Useful Information

Frequently Asked Questions

Frequently Asked Questions

(Note: The Medical Device Control Office has been renamed as the Medical Device Division with effect from 1 October 2019. Please refer to Contact Us page for updates in contact information and contact our office for enquiry, if necessary.)

General

What is a medical device?Expand
Is Your Product A Medical Device?Expand
What is the existing legislative control of medical devices?Expand
Why do we need to regulate medical devices?Expand
Would regulation limit the choice of medical devices available in the market?Expand
What is the progress on the regulation of medical devices so far?Expand
Do overseas countries have regulation on medical devices?Expand
What is the International Medical Device Regulators Forum?Expand

Classification of medical devices

How many classes of medical devices are there?Expand
What are the principles in classifying general medical devices and in vitro diagnostic medical devices?Expand
What is the purpose of separating medical devices into different classes?Expand
How can I know the class of a particular medical device?Expand
Web-based General Medical Device Classification ProgramExpand
Web-based In Vitro Diagnostic Medical Device Classification ProgramExpand

Medical Device Administrative Control System

What is Medical Device Administrative Control System?Expand
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?Expand
How to submit change application to the Department of Health in regard to the listed medical devices or listed traders?Expand
What are delisted medical devices? Under what circumstances will a medical device be delisted?Expand
What is a Conformity Assessment Body?Expand
Is a medical device incorporating human blood plasma/human red blood cell eligible for listing under MDACS? Expand

Medical Device Adverse Event and Field Safety Corrective Action

What is a reportable medical device adverse event?Expand
What actions will the Department of Health take upon receiving reports of medical device adverse events?Expand
What is a Field Safety Corrective Action?Expand
What are the responsibilities of the local responsible person in relation to product recalls and field safety notices issued by regulatory authorities or the manufacturer?Expand

Others

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