To apply for Class D medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong, you need to follow the process outlined by the Medical Device Division (MDD) of the Department of Health. Here’s a step-by-step guide:

1. Understand the Classification of Devices

• Class D medical devices are considered high-risk devices. Ensure that your device is correctly classified as Class D. Examples of Class D devices include heart valves, implantable defibrillators, and devices used in life-sustaining treatments.

2. Prepare the Necessary Documents

• The application process requires comprehensive documentation. Ensure that you have the following prepared:
  • Application Form MD-14: This is the primary application form for listing medical devices under MDACS.
  • Manufacturer’s Evidence of Conformity: Documents proving that the device conforms to the safety, performance, and quality standards, such as compliance with the international standard ISO 13485 or equivalent.
  • Certificate of Free Sale: Evidence that the device is legally sold or distributed in another country with similar regulatory requirements.
  • Quality Management System (QMS) Certificate: Documentation showing that the manufacturer follows an approved quality management system.
  • Declaration of Conformity: A document from the manufacturer stating the device’s compliance with relevant standards and regulatory requirements.
  • Clinical Data: Any clinical evidence supporting the safety and performance of the device.
  • Product Description: Detailed information about the device, its design, and intended use.
  • Risk Analysis Report: A report on the risks associated with the device and how they are managed.
  • Labeling and Instructions for Use (IFU): Sample labels and instructions provided with the device.
  • Post-Market Surveillance Plan: A plan detailing how the device will be monitored after being sold in Hong Kong.

3. Engage a Local Responsible Person (LRP)

• The Local Responsible Person (LRP) is required to act as a liaison between the manufacturer and the MDD. The LRP must:
  • Be a legal entity registered in Hong Kong.
  • Handle adverse event reporting and recalls if necessary.
  • Be responsible for submitting the application on behalf of the manufacturer.

If you don’t have a local presence in Hong Kong, you will need to appoint an LRP to represent you.

4. Submit the Application

• Submit the completed MD-14 application form and supporting documentation to the Medical Device Division either electronically or in hard copy. The application must include:

  • A completed checklist ensuring all documents are provided.
  • Payment of the applicable fee.

• Applications should be submitted to:Medical Device Division, Department of Health,Address: Room 3101-3102, 31/F, Hopewell Centre, 183 Queen’s Road East, Wan Chai, Hong Kong.

5. Pay the Application Fee

• There is an application fee for submitting the medical device registration. Ensure that the correct fee for a Class D device is paid. The fee is non-refundable.

6. Assessment by the MDD

• The MDD will assess your application, reviewing all documentation and ensuring the device complies with Hong Kong’s regulatory requirements.
• The evaluation process may involve requesting additional information, conducting audits, or seeking clarifications.

7. Approval and Listing

• Once the application is approved, the medical device will be listed in the Medical Device Administrative Control System (MDACS) database. The listing is valid for a specific period (usually five years), after which it must be renewed.

8. Maintain Compliance

• After approval, you must continue to comply with post-market surveillance requirements, report adverse events, and manage any necessary recalls.
• You should also ensure that all labeling and advertising of the device remain compliant with local regulations.