To apply for Class I IVD (In Vitro Diagnostic) medical device registration under Hong Kong’s Medical Device Administrative Control System (MDACS), you must meet specific requirements set by the Medical Device Division (MDD) of the Department of Health. These requirements cover both the documentation and process necessary for a successful application. Below is an outline of the key requirements:

1. Device Classification Verification

• Confirm Device Classification: The device must qualify as a Class I IVD. Class I IVD devices are typically low-risk devices used for diagnostic purposes (e.g., testing reagents, diagnostic kits) that do not present a significant risk to users.
• Scope: Class I IVD devices typically include devices that are self-diagnostic or used in non-invasive procedures with minimal or no direct patient involvement.

2. Required Documentation

You must submit the following documentation to the MDD for the Class I IVD registration:

a. MD-IVD-1 Application Form

• This is the formal application form specific to Class I IVD devices. It contains sections for providing device details, the manufacturer’s information, intended use, and classification details.
• The form should be completed thoroughly with accurate information about the device.

b. Device Description

• A clear description of the device’s design, functionality, intended use, and risk profile. This includes technical specifications, such as device components, working principles, and how it functions in the diagnostic process.

c. Labeling and Instructions for Use

• Labeling: Provide copies of the device’s label(s), which must include the manufacturer’s name and contact information, the device’s name, model number, and any relevant warnings or usage instructions.
• Instructions for Use (IFU): Include clear and detailed instructions explaining how the device should be used safely and correctly. This document should also outline potential hazards, contraindications, and proper disposal methods.

d. Risk Assessment and Management

• Risk Analysis: Conduct a risk analysis in compliance with ISO 14971 (Risk Management for Medical Devices). This document should identify any potential hazards associated with the device and explain how these risks are mitigated.
• Residual Risk: Ensure the risk assessment includes a review of any residual risks, if any, and how these are addressed.

e. Evidence of Safety and Performance

• Provide evidence supporting the device’s safety and effectiveness. This could include:
  • Clinical Performance Data: If available, include clinical or in-vitro testing results that demonstrate the device’s performance in a real-world setting.
  • Validation and Verification Data: Include performance testing reports that validate the device’s functionality and verify its compliance with international standards or regulatory requirements.
• If the device has been cleared by other regulatory bodies (e.g., CE mark or FDA approval), include copies of these approvals as supporting evidence.

f. Declaration of Conformity

• This is a formal statement from the manufacturer confirming that the device complies with applicable regulatory and safety requirements for Class I IVD devices.
• It must be signed by an authorized person from the manufacturing company.

g. Quality Management System (QMS) Documentation (Optional but Recommended)

• ISO 13485 Certification: Although not mandatory for Class I devices, including ISO 13485 certification (or equivalent) can strengthen the application by demonstrating that the manufacturer follows internationally recognized quality standards in manufacturing and managing medical devices.
• If ISO 13485 certification is not available, include an explanation of the manufacturer’s internal quality control and assurance processes, including how the device’s quality and safety are maintained.

h. Manufacturer Information

• Provide full details about the manufacturer, including the name, address, contact information, and any other relevant company information.
• Authorized Representative (for foreign manufacturers): If the manufacturer is based outside Hong Kong, an authorized representative in Hong Kong is required to handle local registration and communication with the MDD. Provide the representative's name, contact information, and the official appointment document.

3. Submission Method and Fees

• Submission: Once all documents are prepared, submit the application and supporting materials to the Medical Device Division (MDD) at the Department of Health, Hong Kong.
• Address: Room 3101, 31/F, Hopewell Centre, 183 Queen's Road East, Wan Chai, Hong Kong.
• Application Fees: While Class I devices may have minimal or no application fees, it’s essential to confirm the latest fee schedule with the MDD.

4. Post-Market Surveillance and Compliance

• Post-Market Requirements: After the device is registered, manufacturers must comply with any post-market surveillance requirements. This includes monitoring device performance, reporting adverse events, and updating the MDD in case of significant modifications to the device.
• Device Modifications: If there are any significant changes to the device after registration (e.g., design changes, new indications for use), these must be reported to the MDD.

5. Additional Considerations

• Language: All documents should be provided in English or Chinese (the official languages for submission to the MDD).
• Market Acceptance: While registration is voluntary for Class I IVD devices, it is recommended for improved market acceptance and to demonstrate compliance with safety standards in Hong Kong.
• Timelines: The application review process for Class I devices is generally faster than for higher-risk classifications, typically taking 2-6 months, depending on the completeness of the application and the workload of the MDD.

Summary of Requirements

1. MD-IVD-1 Application Form
2. Device Description
3. Labeling and Instructions for Use
4. Risk Assessment and Management
5. Evidence of Safety and Performance
6. Declaration of Conformity
7. Quality Management System Documentation (Optional but Recommended)
8. Manufacturer and Authorized Representative Information

By preparing these documents and following the outlined steps, you can apply for Class I IVD medical device registration under Hong Kong’s MDACS. Make sure to consult the MDD for any updates or clarifications.

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