To register a Class C medical device under Hong Kong’s Medical Device Administrative Control System (MDACS), the application must include a range of documents that demonstrate the device’s safety, quality, and performance. These documents must provide evidence of compliance with internationally recognized standards, risk management protocols, and regulatory requirements.

Below is a detailed breakdown of the required documents and how to prepare the application files.

1. Required Documents for Class C Medical Device Registration

The following documents are required for a successful Class C medical device registration:

1.1. Application Form (MD-C2)

• What it is: This is the official application form for registering a Class C medical device.
• How to prepare:
  • Download the MD-C2 form from the MDCO website.
  • Complete all relevant sections, providing details about the device, manufacturer, local representative (if applicable), and the type of conformity assessments performed.
  • Ensure all information is accurate and consistent with the supporting documents.

1.2. Device Description

• What it is: A detailed description of the medical device.
• How to prepare:
  • Provide the device name, model number, and a clear description of its intended use.
  • Include a technical overview covering the device design, materials used, and key functional aspects.
  • Ensure the description aligns with international standards for medical devices.

1.3. Conformity Assessment Evidence

• What it is: Documentation proving that the device conforms to international regulatory standards (e.g., CE marking, FDA approval).
• How to prepare:
  • Submit certificates issued by a recognized third-party regulatory body (e.g., ISO 13485 certification for quality management).
  • Include the Declaration of Conformity, which attests that the device meets relevant safety and performance standards.
  • If applicable, submit CE marking certificates, FDA approvals, or equivalent certifications.

1.4. Essential Principles of Safety and Performance Checklist

• What it is: A checklist confirming that the device complies with the essential safety and performance requirements.
• How to prepare:
  • Use the Essential Principles Checklist provided by MDCO, which outlines the mandatory safety and performance criteria for medical devices.
  • For each principle, indicate how the device meets the requirement, referencing test reports, risk management measures, and clinical data.
  • This document is vital to demonstrate regulatory compliance.

1.5. Risk Management Report

• What it is: A report outlining the risks associated with the device and how they are mitigated.
• How to prepare:
  • Prepare a risk management report based on ISO 14971 standards or equivalent.
  • The report should identify potential risks during the device’s lifecycle (design, manufacturing, usage) and outline measures taken to minimize those risks.
  • Ensure this report is comprehensive and addresses all significant risks associated with the device.

1.6. Clinical Evidence

• What it is: Clinical data demonstrating the safety and performance of the device in its intended use.
• How to prepare:
  • Submit clinical trial reports or clinical evaluation studies showing the device's efficacy and safety in real-world medical use.
  • Include summaries of clinical data or equivalent evaluations performed on the device.
  • If the device has been approved or marketed in other countries, provide data from those jurisdictions.
  • Ensure that the clinical evidence is in line with international guidelines for medical devices.

1.7. Labeling and Instructions for Use (IFU)

• What it is: Product labels and instructions that guide the user on how to safely and effectively use the device.
• How to prepare:
  • Include draft labeling that provides the device name, manufacturer’s information, intended use, warnings, and any contraindications.
  • Provide Instructions for Use (IFU), which should detail how to properly use the device, maintain it, and handle any potential risks.
  • Ensure all labels and instructions comply with MDCO’s regulatory guidelines and are clear, accurate, and appropriate for the device.

1.8. Post-Market Surveillance Plan

• What it is: A plan for monitoring the device’s safety and performance after it has been placed on the market.
• How to prepare:
  • Prepare a Post-Market Surveillance (PMS) plan that details the procedures you will use to monitor the device after it is sold.
  • Include procedures for reporting adverse events, handling product recalls, and submitting periodic updates on device safety to MDCO.
  • Ensure that the PMS plan is robust and meets international regulatory standards.

1.9. Manufacturer’s Information

• What it is: Information about the manufacturer, including their location and regulatory compliance.
• How to prepare:
  • Provide detailed information about the manufacturer, including their address, contact details, and the location of the manufacturing site.
  • Include certification that the manufacturer’s Quality Management System (QMS) is compliant with ISO 13485 or equivalent standards.

1.10. Local Authorized Representative (if applicable)

• What it is: If the manufacturer is not based in Hong Kong, a local authorized representative must be appointed.
• How to prepare:
  • Provide details of the local authorized representative in Hong Kong who will handle all regulatory matters with MDCO on behalf of the manufacturer.
  • Ensure that the representative is fully authorized to act on behalf of the manufacturer, with formal agreements in place.

1.11. Declaration of Conformity

• What it is: A document signed by the manufacturer or applicant, declaring that the device meets all applicable regulatory requirements.
• How to prepare:
  • The Declaration of Conformity should be signed by an authorized representative of the manufacturer.
  • It must affirm that the device complies with the Essential Principles of Safety and Performance and meets all regulatory requirements for Class C devices.

2. How to Prepare the Application Files

Here are some important considerations when preparing your application files for Class C medical device registration:

2.1. File Format and Organization

• Format: All documents should be submitted in PDF format unless otherwise specified. Ensure that electronic copies are clear, legible, and appropriately named.
• Language: Documents must be in English or Chinese. If the original documents are in another language, certified translations must be provided.
• Organization: Group documents logically and clearly. For example:
  • Application form and declaration.
  • Conformity assessment documents (ISO, CE, etc.).
  • Technical documentation (device description, risk management, clinical evidence).
  • Labeling and post-market documents.
• Indexing: It is helpful to provide a cover letter or index to guide the reviewer through the documents.

2.2. Ensure Completeness

• Cross-check that all required documents are included. Missing or incomplete documentation can delay the registration process.
• Ensure consistency between the application form and the supporting documents. Discrepancies in product names, model numbers, or descriptions could lead to rejection or requests for clarification.

2.3. Compliance with Regulatory Requirements

• Verify that your device complies with relevant international standards (ISO, CE marking, FDA approvals) and that you have documented proof of these standards in the form of certificates or conformity assessments.
• Ensure that all risk management and post-market surveillance plans are aligned with regulatory expectations for medium-high risk (Class C) medical devices.

By carefully preparing these documents and following the MDACS guidelines, you can ensure a smoother registration process for your Class C medical device under Hong Kong MDACS.

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