Before applying for Class I medical device MDACS registration in Hong Kong, it’s essential to make thorough preparations to ensure a smooth application process. This includes ensuring that all necessary documentation is in place, understanding regulatory requirements, and establishing processes to meet safety and quality standards.

Key Preparations Before Applying for Class I Medical Device MDACS Registration in Hong Kong

1. Confirm the Classification of the Device

• Device Classification: Verify that your medical device falls under Class I as per Hong Kong's regulations. Class I devices are considered low-risk and are subject to simplified registration procedures, but it's important to confirm the classification.

• Check if a CE Mark or Other Certifications Are Required: If your device has been certified in other markets (e.g., CE marking in the EU or FDA clearance in the US), ensure that the documentation for these certifications is available for reference.

2. Establish a Quality Management System (QMS)

• ISO 13485 Certification: Ensure that you have an established ISO 13485 compliant Quality Management System (QMS) in place. This standard outlines the requirements for a comprehensive QMS, ensuring that your device is consistently produced and controlled according to quality standards.

• Documentation of Manufacturing Process: Document your manufacturing process to demonstrate that your device is produced in a controlled environment, meeting safety and quality requirements.

• Verification of Compliance: Perform internal audits or assessments to ensure that your manufacturing practices are in compliance with ISO 13485.

3. Ensure Risk Management Compliance

• ISO 14971:2019: Implement a risk management process in compliance with ISO 14971, which is designed to help identify, evaluate, and mitigate risks associated with the device. Even for Class I devices, conducting a risk assessment is critical to ensure patient safety.

• Risk Assessment Report: Prepare a detailed risk management report that outlines the potential hazards, risks, and risk control measures.

4. Ensure Product Labeling Compliance

• ISO 15223-1: Ensure that your product labeling complies with ISO 15223-1, which sets the requirements for medical device labeling, including symbols, warnings, and usage instructions.

• Clear Instructions: Provide clear, user-friendly instructions for use (IFU) and ensure that they meet regulatory requirements.

• Labeling Requirements: Ensure the device packaging and labeling are complete, including all necessary symbols and regulatory marks (e.g., CE, if applicable).

5. Prepare the Technical Documentation

• Device Description: Prepare a detailed description of the device, including its intended use, components, and any safety or performance data.

• Design and Manufacturing Information: Provide detailed technical information regarding the design, manufacturing process, and quality control procedures.

• Risk Management Documentation: Include your risk assessment and any risk mitigation measures you have implemented.

• Clinical Evaluation (if applicable): If your device is intended for therapeutic purposes or has direct patient interaction, prepare clinical data or evaluation reports to demonstrate its safety and performance. For Class I devices, clinical data may not always be required, but it's essential to have it if relevant.

6. Establish a Local Responsible Person (LRP)

• Local Representation: If your company is based outside of Hong Kong, you will need to designate a Local Responsible Person (LRP) who is based in Hong Kong. The LRP acts as your point of contact for regulatory matters and ensures that your device complies with Hong Kong’s medical device regulations.

• Verify LRP Registration: Ensure that your LRP is properly registered with the Hong Kong Department of Health (DH) and understands the regulatory obligations involved.

7. Gather Supporting Documents

• Manufacturer Information: Provide information about the manufacturer, including the business registration and contact details.

• Declaration of Conformity: If applicable, provide a Declaration of Conformity stating that the device complies with the relevant regulatory requirements, including international standards (e.g., ISO 13485, ISO 14971).

• CE Marking (if applicable): If your device has been CE marked, provide the relevant certificates and supporting documentation to demonstrate compliance with the European Union’s regulations.

• Certificate of Free Sale: In some cases, the Certificate of Free Sale may be required to confirm that the device is legally sold in other markets.

8. Understand the Hong Kong Medical Device Ordinance (Cap. 599)

• Regulatory Requirements: Familiarize yourself with the Hong Kong Medical Device Ordinance (Cap. 599), which governs medical devices in Hong Kong. Ensure that your device complies with the standards outlined in this ordinance, including the MDACS registration process.

• Registration Process: Understand the specific steps involved in registering your Class I medical device with the Department of Health (DH) under the MDACS system.

9. Prepare for Inspections and Audits

• Manufacturing Site Inspections: Be prepared for any possible inspections of your manufacturing facility or production processes by regulatory authorities in Hong Kong. Ensure that your facility adheres to Good Manufacturing Practices (GMP).

• Compliance with Standards: Be ready to demonstrate compliance with all relevant international standards (e.g., ISO 13485, ISO 14971) if requested by the Department of Health.

10. Set Up Record-Keeping and Traceability Systems

• Traceability System: Establish a system for tracking and tracing devices in the market, especially if there is any recall or safety issue with the device. Ensure that you can trace each unit back to its manufacturing batch or lot.

• Post-Market Surveillance: Prepare a plan for ongoing post-market surveillance to monitor the safety and performance of the device after it is on the market, including procedures for handling adverse event reports.

Summary Checklist Before Applying for MDACS Registration:

1. Confirm device classification as Class I.

2. Implement ISO 13485 QMS and internal audits.

3. Conduct risk assessment and prepare risk management documents (ISO 14971).

4. Ensure product labeling complies with ISO 15223-1.

5. Prepare technical documentation, including device description, design, and manufacturing information.

6. Designate a Local Responsible Person (LRP) if based outside Hong Kong.

7. Gather supporting documents: manufacturer information, Declaration of Conformity, CE Mark (if applicable), and Certificate of Free Sale.

8. Understand the Hong Kong Medical Device Ordinance and MDACS registration process.

9. Prepare for inspections and demonstrate GMP compliance.

10. Set up record-keeping systems for traceability and post-market surveillance.

By thoroughly preparing these materials and ensuring compliance with both local and international standards, you can facilitate a smooth application process for registering your Class I medical device in Hong Kong.

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