To apply for Class IV medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), certain conditions must be met to ensure that your device complies with the regulatory framework and is eligible for registration. These conditions pertain to the device's classification, local representation, technical documentation, and prior approval in a reference country. Below are the key conditions that must be fulfilled:

✅ 1. Class IV Device Classification

• Class IV devices are the highest-risk medical devices and typically include:

  • Implantable devices.

  • Devices that support or sustain life.

  • Devices that present a high risk of harm in case of failure.

• Devices must be classified according to their risk level in compliance with the MDACS classification system.

• Class IV devices require rigorous scrutiny and documentation to ensure their safety and efficacy.

✅ 2. Local Responsible Person (LRP)

• The Local Responsible Person (LRP) must be a legal entity in Hong Kong.

• The LRP must:

  • Be responsible for submitting the registration application.

  • Act as the point of contact with the Medical Device Division (MDD).

  • Maintain all regulatory records and handle post-market surveillance requirements.

• LRP requirements:

  • Must be registered with the Department of Health.

  • Must be able to provide support for post-market obligations, such as adverse event reporting and device recalls.

✅ 3. Prior Approval in a Reference Country

• The device must be approved in at least one reference country. Examples of reference countries and approval authorities include:

  • European Union (EU): CE mark (compliant with MDR).

  • United States (FDA): 510(k) clearance or Premarket Approval (PMA).

  • Australia (TGA): Australian Register of Therapeutic Goods (ARTG) listing.

  • Canada (Health Canada): Medical Device License (MDL).

  • Japan (PMDA/MHLW): Medical Device Approval.

• The reference country approval demonstrates that the device meets international standards for safety and efficacy.

✅ 4. Compliance with Applicable Standards

• The device must comply with relevant international standards, such as:

  • ISO 13485: Quality Management Systems for medical devices.

  • ISO 14971: Risk management for medical devices.

  • ISO 10993: Biocompatibility standards for medical devices (if applicable).

• You may need to submit the Certificate of Compliance or other proof of conformity with these standards.

✅ 5. Technical Documentation

• The application for Class IV device registration must be accompanied by comprehensive technical documentation, including:

  • Device Description: Detailed information on the device's design, materials, intended use, and features.

  • Clinical Evaluation Report (CER): Documentation demonstrating the device’s clinical performance and safety, including clinical trial data if applicable.

  • Risk Management File: Based on ISO 14971, including risk analysis, evaluation, and control measures.

  • Quality Management System Certificate: Evidence of ISO 13485 certification or equivalent.

  • Post-market Surveillance (PMS) Plan: Strategy for monitoring the device once it is on the market, ensuring long-term safety and effectiveness.

  • Labeling and Instructions for Use (IFU): Must comply with local regulations and be available in English or Chinese.

✅ 6. Device Labeling and IFU Compliance

• The labeling and instructions for use (IFU) must meet specific regulatory requirements, including:

  • Clear indication of device identity (name, model, etc.).

  • Manufacturer details, including contact information.

  • Safety warnings, contraindications, and any special handling instructions.

  • Instructions for proper use, including any necessary maintenance or precautions.

✅ 7. Manufacturing Site and Documentation

• The manufacturer must provide documentation confirming that the device is produced in a facility that complies with good manufacturing practices (GMP) or ISO 13485 standards.

• The device must be manufactured in a recognized quality-controlled environment to ensure consistent product quality.

✅ 8. Post-Market Surveillance and Vigilance System

• The manufacturer and LRP must have an established post-market surveillance (PMS) plan to:

  • Monitor the safety and performance of the device after it is placed on the market.

  • Report any adverse events or device recalls to the Medical Device Division (MDD).

✅ 9. Fee and Processing Time (Currently Free)

• Fee: Currently, there is no registration fee under MDACS.

• Processing time: It can vary, but typically it may take 2 to 6 months for the device registration to be completed, depending on the completeness and clarity of the application.

❗ Additional Considerations

• Device Updates: Any updates in device design, labeling, or changes in the regulatory status must be reported to the MDACS.

• Post-Market Requirements: Compliance with post-market surveillance, vigilance reporting, and adverse event reporting is crucial for maintaining the device’s status on the MDACS list.

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