To apply for Class A medical device registration under Hong Kong's MDACS (Medical Device Administrative Control System), certain conditions must be met. These conditions ensure that only low-risk devices are registered under the system. Here’s an overview of the key conditions:

✅ 1. Device Classification

Class A Criteria:

Class A medical devices are considered low risk and non-invasive. The device must meet the following characteristics:

• Non-invasive: The device does not enter the body or breach the skin.

• Low-risk: The device poses minimal risk to patients or users, typically with no critical safety concerns.

• Non-sterile: The device does not require sterilization.

• Non-measuring: The device does not measure or monitor biological parameters.

• Non-implantable: The device is not intended to remain inside the body.

Examples of Class A devices:

• Bandages, plasters, basic surgical instruments (scalpels, scissors).

• Non-invasive thermometers.

• Wheelchairs, crutches, walking aids.

If the device does not meet these low-risk characteristics, it will not qualify for Class A registration.

✅ 2. Manufacturer and Responsible Person

• Local Responsible Person (LRP):

  • If the manufacturer is located outside Hong Kong, they must appoint a Local Responsible Person based in Hong Kong to handle regulatory matters.

  • The LRP must be listed with the Medical Device Division (MDD) prior to submission.

  • If the manufacturer is based in Hong Kong, no LRP is required.

Conditions for LRP:

• The LRP must ensure that the device complies with Hong Kong regulations.

• They are responsible for maintaining post-market surveillance, including reporting adverse events and device recalls.

✅ 3. Regulatory History

• Compliance with Local and International Standards:

  • While not mandatory for Class A devices, it is recommended that the device be compliant with relevant international standards, such as ISO 13485 for quality management, and CE or FDA approval (if applicable).

  • Having these approvals can help demonstrate the safety and quality of the device, but they are not required for Class A devices in Hong Kong.

✅ 4. Documentation and Submission

• Complete Documentation: All required documents (MD-TRF form, device description, classification justification, labeling, etc.) must be accurately completed and submitted.

• Language: All documents must be in English or Traditional Chinese.

• No Fee: Registration for Class A devices is free of charge under MDACS.

✅ 5. Post-Market Compliance

• Post-Market Surveillance: The Local Responsible Person is responsible for maintaining regulatory compliance after the device is listed.

  • This includes reporting adverse events, product recalls, and any changes in device details (such as labeling or manufacturing location).

✅ Summary of Conditions for Applying for Class A Medical Device Registration

• Device must meet the low-risk, non-invasive, non-sterile criteria (Class A characteristics).

• Manufacturer must appoint a Local Responsible Person (LRP) if based outside Hong Kong.

• Complete all required application documents (MD-TRF form, device description, classification justification, labeling, etc.).

• Optional but recommended: Compliance with international standards like CE or FDA (not required but beneficial).

• Submit the application to the Medical Device Division (MDD) for review.

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