Here’s a straightforward guide on how to process Class B medical device MDACS registration in Hong Kong:

How to Process Class B Medical Device MDACS Registration

Step 1: Determine Device Classification

• Confirm your device falls under Class B according to Hong Kong’s MDACS classification rules.

Step 2: Appoint a Local Responsible Person (LRP)

• The LRP must be based in Hong Kong.

• They act as your official contact point with the Medical Device Division (MDD).

Step 3: Prepare Application Documents

Gather the following:

• Completed Form MD1 (Application for Device Listing)

• Device technical documentation (device description, labeling, instructions for use, risk management, etc.)

• Quality Management System certificate (ISO 13485)

• Evidence of market approval from recognized authorities (e.g., CE mark, FDA clearance)

• Letter of appointment of the Local Responsible Person

• Payment proof for application fee (HK$500 per device)

Step 4: Submit Application

• Send the application package to the Medical Device Division, Department of Health, Hong Kong.

• Submission can be done by mail or in person.

Step 5: Pay Application Fee

• HK$500 per device listing.

• Include proof of payment with your submission.

Step 6: Application Screening & Review

• MDD will perform an initial check for completeness.

• After passing screening, a detailed technical review follows.

• Respond promptly to any MDD queries.

Step 7: Receive Registration Approval

• Upon successful review, MDD will issue a registration/listing number.

• You can then legally market your Class B device in Hong Kong.

Step 8: Post-Registration Compliance

• Implement post-market surveillance.

• Report adverse events or significant changes to MDD.

• Keep documentation updated and notify MDD of any changes.

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