After obtaining Class B medical device registration under MDACS (Medical Device Administrative Control System) in Hong Kong, there are several key post-listing obligations and considerations you should be aware of to ensure continued compliance:

✅ 1. Listing Validity and Maintenance

• Validity: Device listing under MDACS does not expire, but must be maintained.

• The Local Responsible Person (LRP) must notify the Medical Device Division (MDD) of:

  • Changes in manufacturer, device model, or classification

  • Changes to labeling, Instructions for Use (IFU), or packaging

  • Regulatory status changes (e.g., CE mark withdrawn)

📌 Use Form MD5 (Notification of Changes) to report updates.

✅ 2. Post-Market Surveillance (PMS)

• Although MDACS is voluntary, the LRP is expected to monitor safety and report incidents:

  • Adverse events or field safety corrective actions (FSCA) must be reported to MDD.

  • Report using Form MD7.

📌 Refer to Guidance Note GN-10 for PMS obligations.

✅ 3. Labeling Compliance

• All devices sold or distributed in Hong Kong must carry:

  • Correct labeling (English or Chinese)

  • Listing number (if issued)

  • Manufacturer details, model, lot/serial number, expiry date

📌 Continue to comply with GN-03 – Labelling Requirements.

✅ 4. Record Keeping

• The LRP must maintain records of:

  • Sales and distribution

  • Complaints and recalls

  • Correspondence with regulatory bodies

Retention period: 5 years after last date of manufacture or supply.

✅ 5. Promotion and Advertising

• Ensure all promotional materials (brochures, websites, packaging) are:

  • Accurate, not misleading

  • Consistent with the intended use and claims submitted during registration

✅ 6. Inspection and Audit

• Although MDACS is voluntary, MDD may conduct spot checks or request documentation at any time.

Be prepared to provide:

• Updated QMS certificates

• Technical documentation

• Traceability records

✅ 7. Voluntary Delisting

If you intend to stop supplying the device in Hong Kong:

• Submit Form MD6 to voluntarily delist the device.

• Remove the listing number from packaging and marketing materials.

✅ 8. Keep Reference Market Approvals Valid

• Ensure your reference market certificate (e.g. CE, FDA, TGA) remains valid.

• If revoked or expired, MDACS listing must be updated or reconsidered.

✅ 9. Monitor MDACS Updates

• Regularly check the MDD website for:

  • Updated guidance notes

  • Changes in submission procedures or regulatory policy

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