Medical Devices Regulations in Hong Kong for Registration of Devices of different class based on risk profile. In Hong Kong, all medical devices intended for local sale, import, or use must be registered with the MDCO. The Medical devices registration process involves the following steps: a. Submission of Application: Manufacturers or their authorized representatives must submit a registration application along with relevant supporting documents, including the device's technical specifications, labelling services, and evidence of compliance with relevant standards. b. Review and Evaluation: The MDCO reviews the application to ensure compliance with safety, performance, and quality requirements. They may request additional information or clarification during the evaluation process. c. Approval and Issuance of Certificate: Upon successful review, the MDCO grants a registration certificate, allowing the manufacturer to market the medical device in Hong Kong. The certificate is valid for a specified duration, typically five years. Classification of Medical Devices in Hong Kong Medical devices in Hong Kong are classified based on the potential risks associated with their use. The classification system helps determine the regulatory requirements and level of scrutiny imposed on each device class. The classification categories in Hong Kong are as follows: a. Class I: Low-risk devices, such as bandages or tongue depressors, which do not require registration but must comply with relevant safety standards. b. Class II: Medium-risk devices, including certain diagnostic equipment and non-invasive devices, which require registration and conformity assessment. c. Class III: High-risk devices, such as implantable devices and life-supporting equipment, which require registration, conformity assessment, and additional scrutiny. Post-Market Surveillance of Medical Devices in Hong Kong To ensure the ongoing safety and quality of medical devices in Hong Kong, the Medical Device Control Office (MDCO) carries out comprehensive post-market surveillance activities. These activities encompass: a. Adverse Event Reporting: All manufacturers, healthcare professionals, and users have a responsibility to promptly report any adverse events or incidents associated with medical devices to the MDCO. This reporting system plays a critical role in identifying potential risks and facilitating appropriate actions to mitigate them. b. Market Sampling and Inspections: The MDCO conducts regular random sampling and inspections of registered medical devices to assess their adherence to regulatory requirements and quality standards. This proactive approach helps ensure that the devices available in the market meet the necessary safety and performance criteria. c. Device Recalls & Safety Alerts: https://www.artixio.com/post/medical-devices-regulations-in-hong-kong

1. Medical Devices Regulations
HONG KONG

2. Medical Device Control Office (MDCO)
under the Department of Health
oversees the regulation of medical
devices in Hong Kong

3. All medical devices intended for local sale, import, or
use must be registered with the MDCO
A
Submission of
Application
Review and
Evaluation
Approval and Issuance
of Certificate
B
C
Manufacturers or their authorized representatives must submit a registration
application along with relevant supporting documents, including the device's
technical specifications, labelling services, and evidence of compliance with
relevant standards.
The MDCO reviews the application to ensure compliance with safety,
performance, and quality requirements. They may request additional information
or clarification during the evaluation process.
Upon successful review, the MDCO grants a registration certificate, allowing the
manufacturer to market the medical device in Hong Kong. The certificate is valid
for a specified duration, typically five years.

4. Classification of Medical
Devices in Hong Kong
Class I
Class II
Class III
Low-risk devices, such as bandages or tongue depressors, which
do not require registration but must comply with relevant safety
standards.
Medium-risk devices, including certain diagnostic equipment
and non-invasive devices, which require registration and
conformity assessment
High-risk devices, such as implantable devices and life-
supporting equipment, which require registration, conformity
assessment, and additional scrutiny.

5. Post-Market Surveillance of Medical
Devices in Hong Kong
Adverse Event
Reporting Market Sampling
and Inspections
Device Recalls
and Safety
Alerts
All manufacturers, healthcare professionals,
and users have a responsibility to promptly
report any adverse events or incidents
associated with medical devices to the
MDCO. This reporting system plays a critical
role in identifying potential risks and
facilitating appropriate actions to mitigate
them
The MDCO conducts regular random
sampling and inspections of registered
medical devices to assess their adherence to
regulatory requirements and quality
standards. This proactive approach helps
ensure that the devices available in the
market meet the necessary safety and
performance criteria.
In situations where a medical device is
found to pose a significant risk to patient
safety, the MDCO takes decisive action
by issuing recalls or safety alerts.

6. Technical
Documentation
Review
Quality Management System
Audit
Performance
Testing
The MDCO evaluates the technical
documentation provided by the
manufacturer to ensure it demonstrates
compliance with safety, performance, and
quality standards.
Some devices may undergo performance
testing to validate their functionality,
accuracy, and reliability.
For higher-risk devices, an audit of
the manufacturer's quality
management system may be
conducted to assess their ability
to consistently produce safe and
effective devices.
Conformity Assessment

7. Hong Kong's medical device regulations align with international standards,
including the Global Harmonization Task Force (GHTF) guidelines and the
International Medical Device Regulators Forum (IMDRF) frameworks. This
harmonization facilitates the smooth international trade of medical devices and
enhances patient safety by ensuring consistent standards across jurisdictions.
Harmonization with
International
Standards

8. Collaboration and
Information Exchange
The MDCO actively collaborates with
regulatory authorities, industry
stakeholders, and international
organizations to exchange information and
stay updated on emerging trends and best
practices. This collaborative approach
fosters continuous improvement in the
regulation and oversight of medical devices
in Hong Kong.

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