The process for registering a B-class medical device under the Medical Device Administrative Control System (MDACS) in Hong Kong involves several steps to ensure that the device meets safety, effectiveness, and regulatory compliance standards. Below is a detailed outline of the steps involved in the MDACS registration process for B-class medical devices:

Step-by-Step Process for B-Class Medical Device MDACS Registration

Step 1: Determine Device Classification

• Understand Classification Criteria: Before starting the registration process, determine whether your device is classified as B-class based on the Hong Kong Medical Device Classification System.
• Refer to Guidance Documents: Consult the MDCO guidelines to understand the specific criteria that categorize your device as B-class.

Step 2: Prepare Technical Documentation

• Compile Required Documents: Prepare the necessary technical documentation to support the safety, efficacy, and quality of the medical device. This typically includes:
  • Device Description: Detailed description of the device, including its intended purpose and indications for use.
  • Design and Manufacturing Information: Information on the design, materials, and manufacturing processes used for the device.
  • Risk Management Report: Documentation demonstrating the risk management process, following ISO 14971 guidelines.
  • Clinical Data: If applicable, provide clinical evaluation reports or studies supporting the safety and performance of the device.
  • Quality Management System (QMS): Evidence of compliance with ISO 13485 or other relevant quality standards.

Step 3: Conduct Risk Assessment

• Perform Risk Analysis: Conduct a thorough risk assessment of the device to identify potential hazards and assess risks associated with its use.
• Implement Risk Controls: Establish measures to mitigate identified risks and document these controls in the technical file.

Step 4: Prepare Labeling and Instructions for Use (IFU)

• Labeling Requirements: Develop labeling for the device that complies with ISO 15223 and MDACS requirements.
• Instructions for Use (IFU): Create comprehensive user instructions that outline the proper use, warnings, contraindications, and maintenance of the device.

Step 5: Submit Application for MDACS Registration

• Application Form: Complete the MDACS registration application form, available on the Medical Device Control Office (MDCO) website.
• Submit Technical Documentation: Include all prepared technical documents, labeling, and IFU as part of the application package.
• Application Fee: Pay the required registration fee as specified by the MDCO.

Step 6: MDCO Review of Application

• Application Assessment: The MDCO will review the submitted application and technical documentation for compliance with regulatory requirements.
• Request for Additional Information: The MDCO may contact you for clarification or additional documentation if needed during the review process.

Step 7: Address Feedback from MDCO

• Respond to Queries: If the MDCO requests further information or modifications to the application, respond promptly to address their concerns.
• Re-submit if Necessary: Make any required changes to the documentation and re-submit if instructed by the MDCO.

Step 8: Approval and Issuance of Registration Certificate

• Receive Approval: If the application meets all requirements, the MDCO will approve the registration.
• Registration Certificate: Upon approval, a registration certificate will be issued, allowing the device to be marketed in Hong Kong.

Step 9: Post-Registration Obligations

• Implement Post-Market Surveillance (PMS): After registration, establish and maintain a PMS system to monitor the device's safety and performance.
• Adverse Event Reporting: Set up procedures for reporting adverse events or incidents involving the device to the MDCO.
• Labeling Updates: Ensure that all labeling and IFUs are kept current and reflect any changes based on post-market experience.

Summary of Key Steps for B-Class Medical Device MDACS Registration

1. Determine Device Classification: Confirm that the device qualifies as B-class.
2. Prepare Technical Documentation: Compile all necessary documents to demonstrate safety and performance.
3. Conduct Risk Assessment: Analyze potential risks and implement controls.
4. Prepare Labeling and IFU: Develop compliant labeling and user instructions.
5. Submit Application: Complete and submit the MDACS application with all supporting documents and fees.
6. MDCO Review: The MDCO will assess the application for compliance.
7. Address Feedback: Respond to any MDCO queries and make necessary adjustments.
8. Receive Approval: Obtain the registration certificate once approved.
9. Post-Registration Obligations: Implement PMS, reporting, and updating practices as needed.

Following these steps will help ensure a smooth registration process for B-class medical devices under the MDACS in Hong Kong. It is essential to stay informed about any changes in regulatory requirements and maintain compliance throughout the device's lifecycle.

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