To register a Class B medical device under the Medical Device Administrative Control System (MDACS) in Hong Kong, the Medical Device Division (MDD) of the Department of Health requires specific documentation and conditions to be met. While the registration is voluntary, it is strongly encouraged for market entry and public procurement.

✅ Requirements for Class B MDACS Registration in Hong Kong

🔹 1. Local Responsible Person (LRP)

Only an LRP can apply for registration.

Requirements:

• Must be based in Hong Kong.

• Must be registered with the MDD using Form MD-TR.

• Must have an official appointment letter from the manufacturer.

• Responsible for:

  • Submission of application

  • Post-market surveillance

  • Adverse event reporting and recalls

🔹 2. Device Classification Confirmation

Ensure the device falls under Class B, based on MDACS classification rules:

Examples of Class B devices:

• Thermometers

• Examination gloves

• Infusion sets (non-critical)

• Low-risk surgical instruments

• Surgical lamps

Classification is determined by:

• Degree of invasiveness

• Contact duration

• Impact on patient safety

🔹 3. Regulatory Approval in Reference Market(s)

You must provide evidence of prior approval from at least one of the following recognised regulatory authorities:

• CE Marking (under EU MDD or MDR)

• US FDA 510(k) or PMA

• TGA (Australia) – ARTG entry

• Health Canada Medical Device License

• Japan PMDA or MHLW approval

📌 If no prior approval is available, you must provide full technical documentation including risk analysis, performance testing, and clinical evaluation.

🔹 4. Quality Management System (QMS)

The manufacturer must have a valid ISO 13485 certificate issued by a recognized certification body.

• The scope must cover the design and/or manufacture of the device.

• Certificate must be valid and issued by an accredited organization.

🔹 5. Technical Documentation

Include the following:

🔹 6. Application Form (Form MD1)

Complete and submit the Device Listing Application Form (MD1) including:

• Manufacturer and LRP information

• Device details and classification

• Declaration of prior regulatory approvals

• List of submitted documents

🔹 7. Application Fee

• A fee is required for each application.

• As of recent guidelines: HK$500 per application (confirm with MDD as this is subject to change).

🔹 8. Submission

• Submit hard copy of the completed Form MD1 and all supporting documents to:

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

🔹 9. Post-Market Responsibilities

Once listed, the LRP is responsible for:

• Incident reporting

• Recalls or safety alerts

• Ongoing compliance with MDACS

• Maintaining traceability and distribution records

📌 Summary Checklist for Class B MDACS Registration

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