The process for applying for Class I medical device MDACS registration in Hong Kong involves several steps to ensure that the medical device meets safety, quality, and regulatory standards. The MDACS (Medical Device Administrative Control System) is managed by the Department of Health (DH). Here's an outline of the steps you need to follow to apply for registration:

Steps to Apply for Class I Medical Device MDACS Registration in Hong Kong

Step 1: Classify the Medical Device

• Verify Device Classification: Confirm that your device qualifies as a Class I medical device. Class I devices are typically low-risk products such as basic instruments or non-invasive devices.

  • Self-declaration is usually sufficient for Class I devices, and they are generally not subject to pre-market approval.

  • However, the device must meet the safety, performance, and risk management criteria defined in Hong Kong's regulations.

Step 2: Appoint a Local Responsible Person (LRP)

• For Non-Hong Kong Manufacturers: If the device is manufactured outside Hong Kong, you must appoint a Local Responsible Person (LRP).

  • The LRP acts as the liaison between the Department of Health and the manufacturer. The LRP will be responsible for handling registration and post-market obligations in Hong Kong.

  • The LRP must be based in Hong Kong.

Step 3: Prepare the Required Documentation

• The following documentation is necessary to submit with your application:

  • Application Form: Complete the MDACS online application form.

  • Device Description: A detailed description of the device, including its intended use, function, and materials.

  • Risk Management File: Documentation that includes a risk assessment and steps taken to mitigate identified risks associated with the device.

  • Manufacturer’s Certificate (ISO 13485): If applicable, provide the ISO 13485 certificate, demonstrating compliance with international quality management standards.

  • Labeling and Instructions for Use (IFU): Ensure the device’s labeling meets the regulatory requirements of Hong Kong, including any necessary language and safety warnings.

  • Clinical Evidence (if applicable): For Class I devices, clinical data is typically not required unless there are higher risks associated with the device.

Step 4: Submit the Application via MDACS Portal

• Create an Account: Log in to the MDACS portal (administered by the Department of Health).

• Complete the Application Form: Fill out the online application form with the necessary device and manufacturer information.

• Upload the Required Documents: Submit the technical documents, including the risk management file, device description, and other supporting documents.

• Pay the Registration Fee: After submitting the form and documents, pay the registration fee. The fee structure is available on the MDACS portal.

Step 5: Application Review by the Department of Health

• The Department of Health will review the application and supporting documents. They will assess whether the device meets the regulatory requirements.

  • The review may include checking the device description, risk management process, and quality management system (ISO 13485 if applicable).

  • If the DH has any questions or requires additional information, they will request clarification.

Step 6: Issuance of Registration Certificate

• If the Department of Health is satisfied with the application, they will issue a registration certificate for the Class I device.

  • The registration allows you to legally market and distribute the device in Hong Kong.

Step 7: Post-Registration Compliance

• After registration, you must comply with post-market surveillance requirements:

  • Report any adverse events or issues related to the safety or performance of the device.

  • Maintain compliance with regulatory requirements, including updating device information if necessary.

  • Ensure continued monitoring of the device’s safety and performance in the market.

Key Points to Remember

• Local Responsible Person (LRP) is required for foreign manufacturers.

• Documentation must be thorough and complete to avoid delays in the review process.

• Class I devices typically do not require clinical trials but must meet all safety and performance standards.

• Post-market monitoring and reporting of any adverse events are required after registration.

Following these steps and ensuring your application is complete and accurate will help ensure a smooth registration process for your Class I medical device in Hong Kong.