After applying for Class I medical device MDACS registration in Hong Kong, there are several rules and requirements that must be followed to ensure ongoing compliance with the regulatory framework set by the Department of Health (DH). These regulations cover post-registration activities, including the maintenance of quality standards, proper labeling, and reporting requirements.

Key Rules and Requirements to Follow After MDACS Registration in Hong Kong

1. Adherence to Post-Market Surveillance Obligations

• Continuous Monitoring: Even after registration, you must continuously monitor the performance and safety of your medical device in the market. This includes gathering feedback from users, healthcare professionals, and distributors.

• Adverse Event Reporting: You are required to have a system in place to collect and report any adverse events or device-related incidents to the Department of Health (DH). This includes incidents where the device causes harm or poses a safety risk.

• Corrective and Preventive Actions (CAPA): In the event of an adverse event or performance issue, you must implement corrective and preventive actions. This includes investigating the issue, addressing the root cause, and taking steps to prevent future occurrences.

2. Labeling and Instructions for Use (IFU) Compliance

• Accurate and Updated Labeling: Ensure that all product labeling (including packaging and instructions for use, IFU) is kept up-to-date and in compliance with the applicable requirements. Any changes to the labeling or IFU must be reported to the Department of Health.

• Labeling Requirements: The labeling should meet the requirements outlined in ISO 15223-1, including proper symbols, warnings, and the manufacturer's details. Any claims made on the labels should be scientifically substantiated and in line with approved marketing practices.

3. Maintain a Quality Management System (QMS)

• Ongoing Compliance with ISO 13485: You must maintain a Quality Management System (QMS) that complies with ISO 13485, ensuring that the device is consistently produced and controlled to meet quality standards. This includes regular internal audits and assessments.

• Document Control: Ensure proper document control for all production, quality, and regulatory records. This includes retaining records of the design, manufacturing, and post-market surveillance activities.

4. Notification of Changes in Device or Manufacturer Information

• Device Modifications: If there are any significant changes to the device, such as design, materials, intended use, or manufacturing processes, you must notify the Department of Health. Depending on the nature of the change, you may need to submit an updated registration application or amendment.

• Manufacturer or Distributor Changes: If there are any changes in the manufacturer's details (including name, address, and contact information), or changes in the distributor or Local Responsible Person (LRP), the DH must be informed. Changes in the LRP must be particularly noted if the device manufacturer is located outside Hong Kong.

5. Post-Market Reporting Requirements

• Incident Reporting: If any adverse events, device defects, or recalls occur, these incidents must be reported to the Department of Health in a timely manner. Reports should follow the guidelines for serious incidents that could harm the patient or user.

• Field Safety Corrective Actions (FSCA): In the event of a safety issue, manufacturers are required to implement a Field Safety Corrective Action (FSCA), which involves notifying customers, healthcare providers, and authorities if the device needs to be recalled or corrected.

6. Periodic Re-assessment and Registration Renewal (if applicable)

• Device Re-evaluation: Even though Class I devices are usually subject to less frequent re-registration, ensure that your device remains compliant with local regulations. Regular reviews may be required if the device undergoes significant changes or if regulatory requirements change.

• Re-registration Process: Depending on updates to the regulatory framework, your device may need to be re-registered or undergo a re-assessment to confirm compliance with new or modified requirements.

7. Ensure Proper Distribution and Marketing Practices

• Marketing and Claims: Any claims made about the device, whether in marketing materials, on packaging, or in communication with healthcare professionals, must be truthful and substantiated by appropriate evidence. Avoid making unsupported medical claims that could mislead users.

• Authorized Distributors: If you are distributing your device through third-party distributors, ensure that these distributors are appropriately authorized and that they understand the regulatory requirements related to the sale of medical devices in Hong Kong.

8. Prepare for Regulatory Audits or Inspections

• Facility Inspections: The Department of Health or other authorities may inspect your manufacturing or storage facilities to verify compliance with Good Manufacturing Practices (GMP) and regulatory standards.

• Inspection Readiness: Keep all documentation up-to-date and ensure that your manufacturing facility is prepared for an inspection at any time. This includes ensuring that records of the production process, quality control measures, and testing are easily accessible.

9. Periodic Review of Regulatory Requirements

• Stay Informed of Regulatory Changes: Regulations and standards may change over time, and it’s your responsibility to stay informed about any updates to the Medical Device Ordinance (Cap. 599) and MDACS. Ensure that you regularly review these updates and make necessary changes to your processes, documentation, or device labeling.

10. Compliance with International Standards

• Adhere to ISO Standards: In addition to maintaining compliance with local Hong Kong regulations, continue to comply with international standards (e.g., ISO 13485, ISO 14971, ISO 15223-1) to ensure that your device meets global quality and safety expectations.

Summary of Key Post-Registration Responsibilities:

1. Post-market surveillance: Continuously monitor safety and performance, and report adverse events.

2. Maintain labeling compliance: Ensure accurate, up-to-date labeling and IFU.

3. Quality Management System (QMS): Maintain ISO 13485 compliance and control documentation.

4. Notify DH of changes: Report any significant changes to the device, manufacturer, or distributor.

5. Incident reporting: Report serious incidents or device malfunctions in a timely manner.

6. Prepare for re-registration: Keep track of any changes to regulatory requirements that may require re-registration.

7. Marketing and distribution: Ensure truthful marketing claims and proper distribution practices.

8. Regulatory inspections: Be ready for regulatory audits or facility inspections.

9. Stay updated on regulations: Regularly review changes in regulations and standards.

10. Compliance with international standards: Ensure adherence to international safety and quality standards.

By following these rules and requirements after the approval of your Class I medical device MDACS registration, you will ensure ongoing compliance and minimize risks associated with device safety, quality, and performance.

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