To register a Class B medical device under the Medical Device Administrative Control System (MDACS) in Hong Kong, follow the steps outlined by the Medical Device Division (MDD) of the Department of Health. While MDACS is voluntary, it is strongly recommended—especially for procurement by public healthcare institutions in Hong Kong.

🔹 Step-by-Step Guide to Register a Class B Medical Device in Hong Kong

1. Identify the Role of Local Responsible Person (LRP)

• Only a Local Responsible Person (LRP) can apply for medical device registration.

• LRP must be:

  • A legal entity registered in Hong Kong

  • Responsible for device safety, performance, and post-market surveillance

If you are a foreign manufacturer, you must appoint an LRP in Hong Kong.

2. Determine Classification

• Class B devices are moderate risk (e.g., suction pumps, thermometers, etc.).

• Ensure correct classification using the MDACS classification rules.

3. Prepare Supporting Documents

You need to submit a Device Listing Application (Form MD1) with supporting documents including:

A. Basic Device Information

• Device name, model, description

• Intended use and instructions for use (IFU)

• Label samples (in English or Chinese)

B. Manufacturer and LRP Info

• Manufacturer’s name and address

• LRP’s company registration and contact

C. Evidence of Conformity

At least one of the following approvals:

• CE Marking (under EU MDD or MDR)

• US FDA 510(k) or PMA

• TGA ARTG listing (Australia)

• Health Canada license

• Japan PMDA approval

If no prior approval is available, you must provide detailed technical documentation including risk analysis, clinical evidence, and quality management system (e.g., ISO 13485).

D. Quality System Certification

• Copy of ISO 13485 certificate of the manufacturer

E. Declaration of Conformity

• Signed document from manufacturer

4. Submit the Application

• Submit Form MD1 and all documents in hard copy to:

  Medical Device Division, Department of Health
  14/F, Guardian House, 32 Oi Kwan Road, Wan Chai, Hong Kong

• Include the application fee (usually HK$500 per device as of the latest info; verify with MDD).

5. Await Review and Listing

• MDD will review the submission.

• You may be asked to provide additional info or clarifications.

• Upon successful evaluation, your device will be listed in the “List of Medical Devices” on the MDD website.

6. Post-Market Obligations

• Maintain records of complaints and incidents

• Notify the MDD of:

  • Product recalls

  • Safety alerts

  • Adverse incidents

✅ Summary Checklist

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