The time required to apply for Class A medical device registration under the Hong Kong MDACS (Medical Device Administrative Control System) generally varies based on the completeness of the application, the complexity of the device, and the current workload of the regulatory authorities. However, the typical processing time is as follows:

Processing Time for Class A Medical Device Registration

• Estimated Time: The registration process for Class A medical devices typically takes approximately 2 to 3 months, assuming that the application is complete and there are no significant issues or additional information requests.

• Factors Affecting Processing Time:

  • The accuracy and completeness of the application.

  • The time taken to resolve any queries or provide additional information requested by the regulatory authorities.

  • The current volume of applications being processed by the Hong Kong Department of Health (DH).

Stages of Review for Class A Medical Device Registration

The review process is generally divided into the following stages:

1. Submission and Initial Screening

• Timeline: 1-2 weeks

• Description: After submitting the application, the Hong Kong Department of Health will conduct an initial review to ensure that all required documents are submitted and complete. This includes checking that the technical documentation, manufacturer details, and other required materials are present.

• Action: Ensure all required documents are properly prepared and submitted via the MDACS portal to avoid delays.

2. Evaluation of Technical Documentation

• Timeline: 2-4 weeks

• Description: The authorities will thoroughly assess the technical documentation submitted with the application. This includes evaluating the safety, performance, and compliance of the device with Hong Kong's medical device regulations.

• Action: Be prepared to provide additional information or clarification if required. This could involve verifying manufacturing practices, device labeling, risk management, and other compliance data.

3. Request for Additional Information (If Applicable)

• Timeline: 2-3 weeks (if applicable)

• Description: If the Hong Kong Department of Health finds any gaps or issues in the submitted documents, they may request additional information or clarification. This could include requests for:

  • More detailed risk assessments.

  • Updated or more detailed labeling information.

  • Compliance documentation or certification.

• Action: Respond promptly to any requests for additional information to avoid delays.

4. Final Review and Approval

• Timeline: 1-2 weeks

• Description: Once all required information has been provided and any queries have been resolved, the Hong Kong Department of Health will conduct a final review of the application and issue a decision. If the device meets all regulatory requirements, it will be approved and registered.

• Action: Ensure that all post-market surveillance and compliance plans are in place, as you may be asked to demonstrate readiness to comply with these requirements.

5. Registration Certificate Issuance

• Timeline: Immediately after approval

• Description: Once approved, the Hong Kong Department of Health will issue the registration certificate for the device. You will receive a registration number for the device, which must be used in all marketing and sales documentation.

Summary of Stages and Timelines

1. Initial Submission and Screening: 1-2 weeks

2. Technical Documentation Evaluation: 2-4 weeks

3. Additional Information Request (if any): 2-3 weeks

4. Final Review and Approval: 1-2 weeks

5. Registration Certificate Issuance: Immediately after approval

Total Processing Time: Typically 2 to 3 months for Class A devices, depending on completeness and the time required for any additional information or clarification.

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