After submitting an application for Class D medical device MDACS registration in Hong Kong, the Local Responsible Person (LRP) and the manufacturer must adhere to specific regulatory obligations, ongoing requirements, and compliance practices to ensure a smooth review process and continued eligibility for listing under the Medical Device Administrative Control System (MDACS).

Below is a comprehensive overview of the regulations and post-submission requirements that must be followed after application submission but before approval, and immediately after approval if granted:

🔷 PART 1: Obligations After Submission but Before Approval

1. ✅ Ongoing Communication with MDD

• All official communications are handled through the MDIS portal.

• The LRP must monitor MDIS regularly for:

  • Requests for clarification

  • Additional document requirements

  • Review status updates

🔹 Action: Respond to any MDD request within the timeframe specified (typically 10–30 calendar days). Failure to respond may result in rejection or administrative closure of the application.

2. ✅ Maintain Document Validity

While under review, the following documents must remain valid and current:

• Manufacturer’s ISO 13485 certification

• Foreign regulatory approvals (e.g., CE/FDA)

• Authorized representative appointments (if applicable)

• Essential technical documents (must not be altered during review unless disclosed)

🔹 Action: Notify the MDD via MDIS if any document is updated, expired, or reissued during the review period.

3. ✅ No Unauthorized Distribution

Devices under review must not be marketed or distributed in Hong Kong until listing is granted, unless:

• An Import Licence is separately obtained under the Pharmacy and Poisons Ordinance (for exceptional access, e.g., hospital tenders).

🔹 Action: Delay all marketing activities, product launches, or sales efforts until MDACS listing is confirmed.

🔷 PART 2: Requirements Immediately After Approval

Once the device is listed, the following regulations and responsibilities take effect immediately:

1. ✅ Device Listing Validity

• Listing is valid for 5 years.

• You must renew the listing before expiration (recommended: at least 6 months in advance).

🔹 Maintain original application documents for audit or renewal.

2. ✅ Labeling Compliance

Ensure the product labeling and Instructions for Use (IFU) meet the requirements outlined in:

• GN-07: Guidance Notes for Labeling

• Include:

  • Device name/model

  • Manufacturer and LRP information

  • Intended use, warnings, lot/serial numbers

  • CE/FDA identifiers (if any)

  • Traditional Chinese and/or English language

🔹 Action: Keep sample labels and packaging on file for inspection.

3. ✅ Adverse Event and Vigilance Reporting

Comply with GN-10 (Adverse Event Reporting):

• Class D devices require mandatory vigilance reporting.

• Must report:

  • Death or serious deterioration of health

  • Device malfunction that could cause harm

• Timeline for submission:

  • 2 calendar days (serious public threat)

  • 10 calendar days (serious deterioration/death)

  • 30 calendar days (other reportable events)

🔹 Action: Maintain an internal AE tracking and reporting system.

4. ✅ Post-Market Surveillance (PMS) System

You must have a documented system to:

• Monitor real-world safety and performance

• Analyze user feedback, complaints, and failures

• Initiate field corrective actions if necessary

🔹 Refer to ISO 13485:2016 Clause 8.2.1 and local guidance on PMS.

5. ✅ Field Safety Corrective Action (FSCA) Compliance

Follow GN-11 (FSCA and Recalls) if:

• Product recall is needed

• Warnings or usage restrictions are issued

• Device requires modification or update

🔹 Action: Notify MDD via MDIS and provide:

• Field Safety Notice (FSN)

• Root cause analysis

• Corrective measures taken

6. ✅ Maintain Validity of Manufacturer Credentials

Ensure the manufacturer continues to hold:

• Valid ISO 13485 certificate

• Active foreign market authorization (e.g., CE, FDA)

🔹 Action: Submit updated certificates or regulatory changes to MDD if applicable.

7. ✅ Recordkeeping and Traceability

Maintain:

• All technical documents submitted for at least 5 years

• Complaint logs, AE reports, recall history

• Distribution and sales records

🔹 Action: Ensure the LRP has access to a complete documentation archive for audit.

8. ✅ Notify MDD of Changes

You must notify MDD in advance of any significant change, such as:

• Change of manufacturer or LRP

• Product design, indication, or labeling change

• Addition of new models or variants

• Change in sterilization or software

🔹 Action: Use MDIS to submit supplementary documentation and variation application.

9. ✅ Use Listing Number Properly

• You may reference the listing number as evidence of MDACS inclusion.

• Do not misrepresent the listing as official regulatory approval or market authorization.

🔹 Suggested language:

"This product is listed under the Medical Device Administrative Control System (MDACS) by the Hong Kong Department of Health."

10. ✅ Prepare for Spot Audit or Reassessment

MDD may conduct audits or request reassessment of:

• Technical documentation

• PMS records

• Complaint handling

• Vigilance activities

🔹 Action: Keep all records accessible and up-to-date.

✅ Summary of Key Post-Application Regulations

Would you like a downloadable Post-Approval Regulatory Compliance Checklist or editable templates for AE reports, FSCA notices, or renewal applications? I can provide those based on your device type and regulatory strategy.

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