The Class IV medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS) is a regulatory process designed to ensure that high-risk medical devices are safe and effective for use in Hong Kong. Class IV devices are considered to carry the highest level of risk and include complex or high-risk devices, such as implantable devices and certain diagnostic equipment.

Here’s a step-by-step process for registering a Class IV medical device under Hong Kong MDACS:

1. Determine the Classification of the Medical Device

Before initiating the registration process, confirm that your device is classified as Class IV under the MDACS classification system. Class IV devices are those that pose the highest risk to patients, such as implantable devices, life-supporting equipment, and certain diagnostic devices.

• If you are unsure of the classification, review the MDACS guidance or consult with regulatory experts.

2. Prepare the Necessary Documentation

A range of technical and regulatory documents must be prepared for the application. These documents typically include:

• Device Description: A comprehensive description of the device, its intended use, indications, and mechanism of action.

• Design and Manufacturing Information: Details about the design, components, and manufacturing process of the device.

• Clinical Evaluation Report (CER): A detailed assessment of clinical data to demonstrate the safety and efficacy of the device, based on clinical studies or literature reviews.

• Risk Management Documentation: Based on ISO 14971, this includes risk analysis, risk control measures, and post-market risk management procedures.

• Quality Management System (QMS) Certificate: Certification that the manufacturer complies with ISO 13485, which ensures good manufacturing practices.

• Labelling and Instructions for Use (IFU): The device label and user instructions must meet Hong Kong’s regulatory requirements.

• Performance and Safety Data: Evidence of the device’s safety and performance from preclinical and clinical tests (e.g., electrical safety data, biocompatibility data for implantable devices).

• Declaration of Conformity: A document stating that the device complies with relevant international standards (e.g., CE marking for EU conformity, FDA approval for US marketing, etc.).

3. Submit the Application

The registration application must be submitted to the Department of Health (DH) in Hong Kong via the MDACS Online System or through the appropriate submission channel provided by the DH. The submission should include:

• Application Form: A completed form that includes details about the device, the manufacturer, and the intended market.

• Supporting Documents: All of the documents prepared in step 2, including technical documentation, clinical evaluation reports, QMS certificates, and any required regulatory certificates (e.g., CE, FDA).

4. Pay the Application Fee

There is a non-refundable registration fee associated with the application, which varies based on the device classification. For Class IV medical devices, this fee tends to be higher due to the complexity and high-risk nature of the devices.

Ensure that the fee is paid in accordance with the instructions provided by the DH to avoid delays in processing.

5. Evaluation and Review

Once the application and all supporting documents are submitted, the Department of Health will evaluate the submission. The evaluation process involves:

• Document Verification: Ensuring all required documents are present and comply with regulatory standards.

• Risk Assessment: The DH will assess the device’s risk profile and evaluate the clinical and safety data provided.

• Inspection (if necessary): In some cases, the DH may request a factory inspection or an audit of the manufacturer's quality management system.

If there are any issues or if additional information is required, the DH may request clarification or supplemental documentation. This could include:

• Request for More Data: Additional clinical data or modifications to the labeling.

• Safety Concerns: Addressing concerns raised during the evaluation, such as unaddressed risks or adverse events.

6. Decision and Issuance of Registration Certificate

After completing the evaluation, the DH will issue a decision regarding the registration. If the device meets all the regulatory requirements, the registration certificate will be granted. This certificate is typically valid for five years.

If the application is rejected or further actions are required, the DH will provide guidance on how to address the issues for re-application.

7. Post-Market Surveillance and Compliance

Once the device is registered, the manufacturer must ensure continuous compliance with Hong Kong’s post-market surveillance requirements, which include:

• Adverse Event Reporting: Reporting any incidents or adverse events associated with the device to the DH.

• Market Monitoring: Ongoing monitoring of device performance and safety, including the implementation of corrective and preventive actions (CAPA).

• Device Recalls and Safety Alerts: If necessary, the manufacturer must act promptly to recall defective or dangerous devices and notify authorities of any safety concerns.

Additionally, manufacturers must be prepared for periodic audits and ensure that any changes to the device or manufacturing process are reported to the DH.

8. Renewal of Registration

Class IV medical device registrations are valid for a period of five years. Manufacturers must apply for renewal before the expiration of the registration to avoid any lapse in the device’s market authorization.

During the renewal process, the manufacturer will need to submit updated technical documentation, confirm that the device continues to meet safety and performance standards, and provide post-market surveillance data.

Key Considerations for Class IV Medical Device Registration under MDACS:

• Documentation Accuracy: Ensure that all technical and clinical documents are accurate, up to date, and meet regulatory standards.

• Risk Management: A comprehensive risk management plan based on ISO 14971 is essential for Class IV devices.

• Clinical Data: For high-risk devices, clinical data may be required to prove the device’s safety and efficacy.

• Post-Market Surveillance: Ongoing surveillance of the device’s performance in the market is mandatory to ensure compliance with safety standards.

• Timely Renewal: Begin the renewal process well before the registration expires to avoid interruptions.

Conclusion

The process for Class IV medical device registration under Hong Kong MDACS involves several key steps, from preparing detailed documentation to submitting the application, undergoing a thorough evaluation, and complying with post-market requirements. It is important to stay proactive throughout the lifecycle of the device, ensuring compliance with the relevant standards and regulations to maintain market access and ensure patient safety.

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