To apply for Class II medical device MDACS registration in Hong Kong, you need to follow a systematic procedure to ensure that the device complies with the Medical Device Administrative Control System (MDACS) regulations. Here’s a detailed outline of the procedures involved:

1. Determine Device Classification

• Identify Device Category: Confirm that your device is classified as Class II based on its risk profile and intended use. Class II devices are typically those with moderate risk, such as diagnostic devices or therapeutic instruments that require more regulatory oversight compared to lower-risk devices.

• Understand MDACS Requirements: Ensure that the device falls under the MDACS and requires registration before it can be marketed in Hong Kong.

2. Appoint an Authorized Representative (AR)

• If you are a foreign manufacturer, you must appoint a local authorized representative in Hong Kong to handle the registration process. The AR will submit the application and represent the manufacturer in all dealings with the Medical Device Control Office (MDCO).

• The AR is responsible for ensuring that the device complies with Hong Kong regulations and for managing post-market surveillance.

3. Prepare Required Documentation

You will need to compile a comprehensive set of documents to support your application. The required documents include:

1. Registration Application Form:

   • Fill out the official MDACS application form for Class II medical devices. This form requests information about the device and its intended use.

2. Technical Documentation:

   • Device Description: Provide detailed descriptions, including design, components, and intended use.

   • Risk Management File: Evidence that you have conducted risk assessments for the device (e.g., in line with ISO 14971 for risk management).

   • Manufacturing Information: Include ISO 13485 certification for quality management systems or equivalent documentation showing that the manufacturer adheres to Good Manufacturing Practices (GMP).

   • Clinical/Performance Data: If applicable, submit clinical trial data, studies, or performance testing to support safety and efficacy.

   • Labeling Information: Submit the product labels and instructions for use, ensuring they comply with the requirements for language, content, and safety information.

   • Declaration of Conformity: A statement from the manufacturer confirming that the device complies with relevant standards (e.g., CE marking, FDA approval).

3. Authorized Representative Information:

   • If you are using a local AR, provide a signed appointment letter detailing their responsibilities in the registration process.

4. Other Compliance Certificates:

   • Submit certificates proving compliance with international standards such as ISO 13485 and ISO 14971, and any relevant regional certifications (e.g., CE mark, FDA approval).

4. Submit the Application

• Submit the completed application, along with all required documentation, to the MDCO. The application can be submitted electronically or in paper format, depending on the method supported by the MDCO.

• Online Submission: You can submit the application via the MDCO's online registration platform if available.

• Paper Submission: If the MDCO requires paper submission, send the documents to the relevant department (Medical Device Control Office, Department of Health, Hong Kong).

5. Review and Evaluation

• Initial Review: The MDCO will initially review the completeness of your application to ensure all required documents have been submitted. If any documents are missing or incomplete, the MDCO will request additional information.

• Device Evaluation: The MDCO will assess the technical documents, including:

  • Evaluation of the device’s safety and performance.

  • Assessment of risk management processes.

  • Review of clinical data (if applicable).

  • Review of the post-market surveillance plan.

• The MDCO may contact the manufacturer or authorized representative for clarifications or additional documentation.

6. Decision

• Approval: If the MDCO is satisfied with the application and the device complies with all regulatory requirements, the device will be approved for registration, and a registration certificate will be issued.

• Registration Number: Upon approval, the device will be assigned a unique registration number, which must be included on all product labels and promotional materials.

• Rejection: If the MDCO finds any issues or concerns (e.g., non-compliance with safety or risk management requirements), the application may be rejected or returned for further clarification.

7. Post-Approval Responsibilities

• Post-Market Surveillance: After receiving registration, manufacturers must establish and maintain a post-market surveillance plan to monitor the device’s safety and performance once it is on the market. This includes reporting adverse events, device recalls, or other significant safety issues to the MDCO.

• Adverse Event Reporting: You must inform the MDCO of any adverse events associated with your device, as well as any corrective actions taken.

• Renewal: The registration is valid for five years. After this period, you must apply for a renewal, which involves submitting updated documentation and paying the renewal fees.

8. Monitor Changes and Maintain Compliance

• Device Changes: If there are any changes to the device’s design, labeling, or intended use, you must notify the MDCO. Depending on the nature of the changes, a new registration may be required.

• Keep Documentation Updated: Ensure that the technical documentation remains current and compliant with any updates to Hong Kong's regulatory framework for medical devices.

9. Ensure Ongoing Compliance

• Quality Management: Continue adhering to the ISO 13485 quality management system or equivalent to maintain the registration.

• Ensure Compliance with Local Regulations: Always comply with Hong Kong’s medical device regulations, including those related to labeling, marketing, and distribution.

Summary of the Procedures:

1. Classify the Device: Confirm it’s Class II and falls under MDACS.

2. Appoint an Authorized Representative (if outside Hong Kong).

3. Prepare the Application Documents: Gather technical documentation, clinical data, labeling, and risk management information.

4. Submit the Application: Submit all forms and documents to the MDCO.

5. MDCO Review: Wait for the MDCO to assess the application, including documentation and safety data.

6. Approval: If successful, receive a registration certificate and unique registration number.

7. Post-Market Surveillance: Implement a system for monitoring the device’s performance in the market.

8. Maintain Compliance: Keep the registration updated and comply with any regulatory changes.

By following these procedures, you can ensure that your Class II medical device is registered and compliant with Hong Kong's regulations, allowing it to be legally marketed and sold in the region.

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