The time frame for applying for Class I IVD medical device registration under Hong Kong's Medical Device Administrative Control System (MDACS) can vary depending on several factors, such as the completeness of the application, the complexity of the device, and the workload of the regulatory authority. Here’s a breakdown of the process and time frame:

Time Frame for Class I IVD Medical Device Registration

1. Preparation of Documentation (Variable):

   • The time taken to prepare the required documentation, including device descriptions, risk assessments, performance data, and labeling, depends on how well the manufacturer is organized and whether they already have the necessary information.
   • This step can take anywhere from a few weeks to a few months.

2. Submission of Application:

   • Once the documentation is prepared, the application can be submitted to the Hong Kong Department of Health.
   • The submission process itself is relatively quick and can typically be completed within 1-2 days if everything is in order.

3. Application Review (Estimated 1-2 Months):

   • The Hong Kong Department of Health will review the application to ensure it meets all the regulatory requirements. This involves checking that all required documents are provided and that the device complies with applicable standards.
   • The review time generally takes around 1 to 2 months, depending on the complexity of the device and the completeness of the application.

4. Issuance of Registration Decision:

   • If the application is complete and meets all the requirements, the registration decision will be issued within the review period (1 to 2 months).
   • If the Department of Health requires additional information or clarification, the process may be delayed, and manufacturers may be asked to provide supplementary documents.

Steps Involved in the Review Process

1. Document Check:

   • The first step in the review process is to verify that all required documents have been submitted. This includes ensuring that the device description, performance data, risk management files, labeling, and manufacturer information are complete and in order.

2. Compliance Review:

   • The Department of Health will evaluate whether the device complies with the relevant safety and performance standards. For IVD devices, this includes ensuring conformity with international standards (e.g., ISO 13485 for quality management and ISO 14971 for risk management) and the requirements set out by Hong Kong’s regulations.
   • The review also includes verifying that the intended use and clinical claims are supported by adequate evidence and that the device labeling is compliant.

3. Risk Management Review:

   • A thorough review of the risk management documentation is conducted. This includes ensuring that the manufacturer has conducted a proper risk analysis in line with ISO 14971 and has addressed all potential risks associated with the device.

4. Performance Data Evaluation:

   • For IVD devices, the performance data (clinical or laboratory data) must demonstrate that the device is safe and effective. The Department of Health will assess whether the submitted data adequately supports the device’s claims and performance characteristics.

5. Labeling and Instructions for Use (IFU):

   • The labeling, packaging, and instructions for use (IFU) are reviewed to ensure that they are clear, accurate, and compliant with regulatory requirements. This includes checking the safety warnings, usage instructions, and expiration dates.

6. Final Decision:

   • Once the Department of Health has completed the review process, they will issue a registration decision. If the device meets all the requirements, it will be registered, and the manufacturer will be issued a registration number.
   • If there are any issues or deficiencies in the application, the Department will request additional information or clarifications from the manufacturer. This may extend the review period.

Overall Time Frame Summary

• Preparation of Documentation: A few weeks to a few months (depending on the manufacturer’s readiness).
• Review Process: Typically 1 to 2 months after submission of the application.
• Total Time: From start to finish, the entire process typically takes around 2 to 3 months for Class I IVD device registration under MDACS, assuming the application is complete and there are no significant issues during the review process.

In cases where the application is incomplete or requires clarification, the process could take longer. It’s also important for manufacturers to plan for potential delays or requests for additional information from the regulatory authorities.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn