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Medical Devices Regulations in Hong Kong: Ensuring Safety and Quality

Updated: Jul 25, 2023

Hong Kong’s vibrant medical and healthcare equipment and devices sector primarily focuses on catering to the needs of the household consumer market. In an exciting development, the total exports of medical and healthcare equipment from Hong Kong witnessed a promising growth of 7.5% in 2021, signifying a thriving industry. However, the subsequent year of 2022 experienced a slight setback, with exports recording a modest decline of 14.9%. These fluctuations highlight the dynamic nature of this sector and call for a closer examination of the contributing factors behind the observed changes. In Hong Kong, the Medical Device Control Office (MDCO) under the Department of Health oversees the regulation of medical devices.

medical devices regulations in hong kong regulatory affairs registration

Medical Devices Registration Process as per Hong Kong Regulations

Medical Device Registration Process:

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.

To register your medical device in Hong Kong, you need to submit the following documents:

  1. Manufacturer/importer's details

  2. Device name and description

  3. Intended purpose of the device

  4. Device classification

  5. Testing or evaluation results

  6. Instructions for Use (IFU)

  7. Proof of Quality Management System Compliance

  8. Summaries of clinical data

  9. Test reports, if required

  10. Additional data requested by the MDCO

  • Classification System:

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:

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 vital 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 and Safety Alerts: 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.

  • Labeling Requirements:

Medical devices in Hong Kong must have clear and accurate labelling, providing vital information for users and regulators. The labelling should include the device's name, intended use, manufacturer's details, instructions, warnings, precautions, and relevant symbols. Furthermore, it is essential to have bilingual labelling in English and Chinese.

  • Clinical Trial Requirements:

In Hong Kong, conducting clinical trials for medical devices requires approval from the regulatory authority. The trial protocol, informed consent forms, and other necessary documents must be submitted for review.

  • Foreign Testing Applicability:

Hong Kong may accept foreign testing data for medical device registration in specific cases. However, the regulatory authority evaluates and uses discretion in accepting such data. Comprehensive documentation and evidence are necessary to prove the reliability and relevance of the foreign testing results.

  • Pre-registration Requirements:

Before registering a medical device in Hong Kong, a pre-registration process must be completed. This involves submitting a detailed application, including classification, intended use, technical specifications, and manufacturing processes.

  • Progressing Registration with EU/US Approval:

Obtaining approval for a medical device in the European Union (EU) or the United States (US) can positively influence the registration process in Hong Kong. The regulatory authority may recognize EU or US approval as supporting evidence of device safety and effectiveness. However, it's important to fulfil Hong Kong's specific requirements in addition to EU/US approval.

  • Import and Distribution Requirements:

Importing and distributing medical devices in Hong Kong necessitates obtaining a valid license from the regulatory authority. License holders must comply with local regulations and standards, ensuring appropriate storage, traceability, and post-market surveillance measures.

  • GMP Inspection Requirements:

Good Manufacturing Practice (GMP) inspections by the regulatory authority evaluate the manufacturing facilities and processes of medical device manufacturers. Adhering to GMP guidelines is essential to ensure device quality, safety, and consistency.

  • Timeline and Associated Fees:

Local entities acting as license holders or Local Responsible Persons (LRPs) bear the responsibility of submitting applications. The LRP serves as the main contact for the Medical Device Department (MDD) regarding device listings. The application processing strives to be finalized within a 12-week timeframe with no associated processing fee.

  • Conformity Assessment:

In addition to the registration process, medical devices in Hong Kong may also require a conformity assessment. This assessment verifies that the devices meet the applicable standards and requirements. Depending on the risk classification, the conformity assessment can include various elements such as:

a. Technical Documentation Review: The MDCO evaluates the technical documentation provided by the manufacturer to ensure it demonstrates compliance with safety, performance, and quality standards.

b. Quality Management System Audit: 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.

c. Performance Testing: Some devices may undergo performance testing to validate their functionality, accuracy, and reliability.

  • Harmonization with International Standards:

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.

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.

In conclusion, the stringent regulations and robust oversight of medical devices in Hong Kong ensure the safety, efficacy, and quality of these crucial healthcare tools. By maintaining strict standards, Hong Kong safeguards the well-being of patients and upholds the integrity of its healthcare system.



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