The process of applying for Class II medical device MDACS registration in Hong Kong typically takes 4 to 6 months from the submission of the application to the issuance of the registration certificate. The timeline can vary depending on the complexity of the application and whether additional information or clarifications are needed. Below is an outline of the stages included in the review process:

1. Application Submission

• Initial Submission: The manufacturer or their authorized representative submits the Class II medical device registration application to the Medical Device Control Office (MDCO), including all required documents such as the technical file, manufacturing information, product labeling, and risk management documents.

• Initial Application Review: The MDCO acknowledges receipt of the application and starts the initial assessment for completeness.

2. Document Evaluation

• Evaluation of Technical Documentation: The MDCO reviews the submitted technical documentation to ensure compliance with Hong Kong’s medical device regulations, as well as relevant international standards (e.g., ISO 13485 for quality management systems, ISO 14971 for risk management).

• Device Classification Review: The MDCO confirms the device’s classification as Class II based on the risk level and intended use of the product.

• Labeling and Instructions: The MDCO checks the product labeling, including packaging and instructions for use, to ensure that they meet the regulatory requirements for clarity and safety.

3. Risk and Safety Evaluation

• Safety and Efficacy Evaluation: The MDCO evaluates whether the device meets safety and performance requirements. This may include assessing the device’s compliance with applicable safety standards and reviewing any clinical or performance data submitted.

• Risk Management Review: The MDCO ensures that the manufacturer has conducted proper risk management procedures, and that any identified risks have been mitigated (e.g., through design controls, labeling, or warnings).

4. Post-Market Surveillance Plan

• Assessment of Post-Market Surveillance: The MDCO reviews the manufacturer’s post-market surveillance plan, including how they will monitor the device’s performance and safety once it’s on the market. This includes assessing the manufacturer's system for handling adverse event reporting, recalls, and corrective actions.

5. Approval Decision

• Issuance of Registration Certificate: If the MDCO determines that the device complies with all applicable regulatory requirements, they will issue the MDACS registration certificate. This certificate allows the device to be marketed and sold in Hong Kong.

• Notification of Registration: The manufacturer is notified that the registration is approved, and they are provided with a unique registration number that must be used on product labeling and promotional materials.

6. Ongoing Monitoring and Compliance

• Post-Approval Monitoring: After the device is registered, the MDCO continues to monitor the device’s safety and performance in the market. Manufacturers are required to report any adverse events or changes to the device’s design or usage.

Summary of Review Stages:

1. Initial Submission and Acknowledgment: The application is submitted and acknowledged by the MDCO.

2. Document Evaluation: MDCO reviews the technical documentation, labeling, and risk management files.

3. Risk and Safety Evaluation: Assessment of safety, efficacy, and risk management compliance.

4. Post-Market Surveillance Plan Review: Evaluation of the manufacturer's post-market surveillance processes.

5. Approval and Registration Issuance: Issuance of the registration certificate if all requirements are met.

Factors That Can Affect the Processing Time:

• Completeness of the Application: If the submitted documents are incomplete or unclear, the MDCO may request additional information, which could delay the process.

• Complexity of the Device: Devices with more complex risk profiles or those requiring additional clinical data may take longer for review.

• Backlog at MDCO: The processing time can also be affected by the workload at the MDCO, especially during peak periods.

In general, expect a processing time of approximately 4 to 6 months for a Class II medical device MDACS registration application, but this may vary based on the factors mentioned above.

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