To apply for Class D medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), you must satisfy a series of regulatory, technical, and administrative conditions. Class D is the highest-risk class, so the Hong Kong Department of Health (DoH) applies strict eligibility criteria.

Below is a detailed list of the conditions that must be met before you can submit an MDACS registration for a Class D medical device:

✅ 1. Device Must Qualify as a Medical Device (Class D)

▸ What qualifies as Class D?

• Devices that sustain or support life

• Devices used in life-threatening situations

• Devices that are implantable (e.g., pacemakers, artificial heart valves)

• In vitro diagnostic (IVD) devices used for:

  • Screening for high-risk infectious diseases (e.g., HIV, hepatitis)

  • Blood grouping or compatibility testing

🔎 Use Technical Reference TR-003 (general MDs) or TR-006 (IVDs) to confirm the classification.

✅ 2. Local Responsible Person (LRP) Must Be Appointed

If the manufacturer is not based in Hong Kong, you must appoint a Local Responsible Person who is:

• A registered business in Hong Kong

• Responsible for:

  • Submitting the registration through MDIS

  • Post-market surveillance and vigilance reporting

  • Product traceability and recall management

📌 Only the LRP can submit an MDACS application on behalf of a foreign manufacturer.

✅ 3. Device Must Have Prior Regulatory Approval in a GHTF Country

The device must already be approved, cleared, or registered in at least one of the following countries/regions:

📄 Proof required: Certificate of Free Sale (CFS) or registration/approval certificate

✅ 4. Manufacturer Must Be ISO 13485 Certified

You must hold a valid ISO 13485:2016 Quality Management System certificate that covers:

• The entire production and design process

• Issued by an accredited and recognized certification body

• The scope must match the product type

✅ 5. Compliance with Essential Principles of Safety and Performance

You must demonstrate conformity to the Essential Principles outlined in:

• GN-01 for general medical devices

• GN-02 for in vitro diagnostic devices

A Declaration of Conformity must be signed and submitted by the manufacturer.

✅ 6. Comprehensive Technical Documentation Must Be Available

You must be able to submit or provide the following:

🗂 These documents must be prepared in PDF format and submitted through the MDIS platform.

✅ 7. The Device Must Be Intended for Marketing or Distribution in Hong Kong

Even though MDACS is voluntary (as of 2025), it applies only to devices that are:

• Distributed, sold, or used in the Hong Kong market

• Not solely for re-export purposes

❗ Devices used only in clinical trials or not for local use do not need MDACS registration.

✅ 8. Clinical Evidence Must Be Sufficient

Because Class D devices involve high risk, the Clinical Evaluation Report must demonstrate:

• Safety under actual use conditions

• Clinical benefit, ideally supported by:

  • Clinical trials

  • Literature analysis

  • Equivalence to approved/predicate devices

🧪 For IVDs: You may need clinical performance data such as sensitivity, specificity, reproducibility, and validation reports.

✅ 9. Post-Market Obligations Must Be Agreed to

As part of registration, the LRP must commit to:

• Ongoing adverse event reporting

• Field safety corrective actions (FSCA) and recalls if necessary

• Maintaining traceability of distributed devices in Hong Kong

• Submitting updated documents if device design or labeling changes

📝 Summary of Conditions

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