Before applying for Class IV medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS), several essential preparatory steps must be undertaken. These steps ensure that the application is complete, compliant with regulatory requirements, and will increase the likelihood of a successful approval. Below are the key preparatory tasks:

1. Understand the Classification of Your Device

• Confirm Device Classification: Class IV medical devices are considered high-risk devices. Understanding your device’s classification within Hong Kong MDACS is crucial. Make sure your device meets the criteria for a Class IV device according to the MDACS classification system. This will help in gathering the correct documentation and identifying the appropriate standards.

• Review Device Characteristics: Review the characteristics of your device, such as its intended use, the potential risks it poses, and the duration of contact with the body. Class IV devices generally involve high-risk procedures, life-supporting or life-sustaining uses, or are implantable.

2. Prepare Technical Documentation

Class IV devices require extensive technical documentation to demonstrate that the device is safe, effective, and compliant with international standards. The following documents should be prepared:

Device Description and Intended Use

• Prepare a clear description of the device, including its design, materials, functions, and intended clinical use.

• Define clinical indications and contraindications, as well as any warranties or restrictions in use.

Risk Management Documentation

• Class IV devices require comprehensive risk management documentation to ensure safety throughout the device lifecycle.

• Prepare a risk analysis in accordance with ISO 14971 (Risk Management for Medical Devices), detailing how risks are identified, mitigated, and monitored.

Clinical Evaluation

• Conduct a clinical evaluation to demonstrate the device’s safety and performance. This may involve clinical trials or literature reviews. The clinical evaluation report should comply with ISO 14155 and be based on clinical data, including any previously conducted clinical investigations, studies, and any relevant publications.

• Ensure the evaluation demonstrates that the device performs as intended in its clinical settings and meets safety requirements.

Compliance with ISO 13485

• Ensure that the quality management system (QMS) is compliant with ISO 13485:2016, which is mandatory for Class IV devices. Prepare and maintain all relevant QMS documentation, including:

  • Standard operating procedures (SOPs)

  • Design controls

  • Manufacturing procedures

  • Post-market surveillance plans

Manufacturing and Quality Assurance Documentation

• Compile documents that demonstrate compliance with relevant manufacturing standards and the quality assurance processes implemented for the production of the device.

• This includes supplier evaluations, materials control, production process validation, and other related quality documentation.

Biocompatibility and Safety Data

• Prepare biocompatibility testing results according to ISO 10993, demonstrating that the materials used in the device do not pose any risk to patients.

• If applicable, prepare data on the sterilization processes (e.g., ISO 11135 for ethylene oxide sterilization) and packaging validation to ensure the device remains sterile until use.

Electrical Safety (IEC 60601 Series)

• If the device includes electrical components, ensure compliance with the IEC 60601 series, which addresses safety standards for electrical medical devices. This includes electromagnetic compatibility (EMC) and functional performance requirements.

3. Engage a Local Responsible Person (LRP)

• If your company is not based in Hong Kong, appoint a Local Responsible Person (LRP), who will act as your point of contact with the Hong Kong Department of Health (DH).

• The LRP is responsible for ensuring that all regulatory requirements are met, submitting the application, and managing communication with the Department of Health.

4. Establish a Post-Market Surveillance (PMS) Plan

• As a Class IV medical device, a robust Post-Market Surveillance system is mandatory. Prepare a PMS plan that outlines the process for monitoring the device’s performance and safety once it is on the market.

• Include procedures for adverse event reporting, product recalls, and ongoing clinical evaluations. This should align with ISO 14971 and other post-market monitoring standards.

5. Prepare a Labeling and Instructions for Use (IFU)

• Ensure that the labeling and Instructions for Use (IFU) comply with the MDACS requirements and standards. This includes:

  • Device name and model

  • Intended use and clinical indications

  • Manufacturer's contact information

  • Warnings and contraindications

  • Lot number, serial number, or unique device identifier (UDI)

  • Proper handling, storage, and maintenance instructions

  • Compliance with the bilingual language requirement (English and Chinese).

• The IFU must provide clear instructions on how to use the device safely, including potential risks and the necessary precautions.

6. Confirm Compliance with Standards

• Review Applicable Standards: Ensure that your device meets international standards such as ISO 13485, ISO 14971, IEC 60601, ISO 10993, and any other relevant standards.

• Testing Reports: Collect and compile all relevant test reports (e.g., biocompatibility testing, electrical safety testing, sterility validation, etc.).

7. Prepare a Labeling and Marketing Plan

• In Hong Kong, medical device labeling must meet certain regulatory requirements. Ensure that your device’s packaging includes appropriate labeling information in both English and Chinese.

• Develop a marketing plan that complies with MDACS regulations. Ensure that any claims made about the device are accurate and supported by clinical or performance data.

8. Assess Device’s Regulatory History in Other Markets

• If the device has already been approved in other regions, ensure that you have access to approval documentation, including any regulatory submissions or approvals from markets such as the EU (CE mark), FDA (USA), Japan (PMDA), or China (NMPA).

• This can help in demonstrating compliance with international safety and performance standards, especially when conducting a clinical evaluation.

9. Prepare the Application Forms

• Familiarize yourself with the official MDACS application forms required for Class IV medical device registration. These forms must be completed accurately with all necessary documentation attached.

10. Budget and Timeline Planning

• Budgeting: Determine the budget required for preparing and submitting the registration application, including costs for clinical trials, testing, technical documentation preparation, and regulatory consultant fees.

• Timeline: Establish a timeline for the registration process, including how long each phase (clinical trials, testing, document preparation, etc.) will take. This will help you plan the overall duration until approval is granted.

Conclusion

Preparing for Class IV medical device registration under Hong Kong MDACS is a detailed and multi-step process that requires careful attention to regulatory standards, documentation, and local requirements. By ensuring all the necessary documentation is in place, engaging with a local responsible person, and adhering to the required standards, manufacturers can streamline the process and increase the likelihood of successful registration.

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