Before applying for D-class medical device registration in Singapore with the Health Sciences Authority (HSA), you need to conduct thorough preparatory work to ensure your device meets regulatory requirements and that the application process goes smoothly. Here is a step-by-step guide on the key preparatory work:

1. Understand Regulatory Requirements

• Review the Health Products Act (HPA) and associated regulations to fully understand the obligations for registering a high-risk medical device (D-class) in Singapore.
• Familiarize yourself with the HSA's medical device registration guidelines, which detail the necessary documentation and processes for submission.
• Ensure you understand the risk classification criteria, including why your device qualifies as D-class based on its intended use, patient risk, and device complexity.

2. Verify Manufacturer and Product Information

• Manufacturer Details: Ensure that the manufacturer is registered with the HSA or an authorized representative is appointed in Singapore (if the manufacturer is located outside Singapore).
• Device Information: Gather comprehensive details about the device, including:
  • Product name and description
  • Intended use and indications
  • Device classification
  • Risk assessment (including hazard identification, risk evaluation, and mitigation strategies)

3. Establish a Quality Management System (QMS)

• ISO 13485 Certification: Ensure that the manufacturer is compliant with ISO 13485 for medical device quality management.
• Prepare documentation for your QMS, which should include processes for device design, production, risk management, testing, and post-market surveillance.
• Verify that Good Manufacturing Practice (GMP) standards are followed in the production of the device.

4. Risk Management and Clinical Data

• Risk Management Plan: Create a risk management plan in line with ISO 14971, documenting how the risks associated with the device are identified, evaluated, and mitigated.
• Clinical Data and Evidence: Prepare the clinical evidence required to demonstrate the safety and effectiveness of the device, especially for D-class devices that require clinical studies or post-market surveillance data.
• Ensure that you have clinical trials or literature reviews to back up the claims made about the device's performance.

5. Regulatory Standards Compliance

• ISO 10993 (Biocompatibility): Ensure that biocompatibility testing has been performed, especially for devices in contact with tissues or that are implanted.
• IEC 60601 (Electrical Safety): If the device is electrical, it must comply with IEC 60601 for electrical safety and performance.
• ISO 20417 (Labeling): Ensure your device complies with labeling standards, including clear and accurate labeling and Instructions for Use (IFU).

6. Prepare the Technical Documentation

• Device Description: Prepare a comprehensive technical file that includes:
  • Device description, intended use, and classification
  • Risk management documentation (e.g., Risk Analysis and Risk Control Measures)
  • Clinical data and trial reports (if applicable)
  • Design and manufacturing process documentation
  • Labeling and IFU
• Test Reports: Gather all relevant test reports (e.g., biocompatibility tests, electrical safety tests, clinical trials, etc.).
• Declaration of Conformity: Prepare a Declaration of Conformity confirming that the device meets regulatory requirements and international standards.

7. Appoint a Local Authorized Representative (if applicable)

• If the device is manufactured outside Singapore, you must appoint a local authorized representative who is based in Singapore to handle registration matters on behalf of the manufacturer.
• The authorized representative will act as a point of contact for HSA and be responsible for regulatory compliance in Singapore.

8. Develop Post-Market Surveillance (PMS) Plan

• Prepare a Post-Market Surveillance (PMS) plan to ensure ongoing safety and performance monitoring of the device after it is placed on the market.
• Include plans for adverse event reporting, product recalls, and routine reviews of the device's safety and performance.

9. Prepare Labeling and Instructions for Use (IFU)

• Ensure that the device’s labeling complies with ISO 20417 and includes all necessary information such as:
  • Product name, manufacturer details, and intended use
  • Warnings, contraindications, and instructions
• The IFU should be clear, concise, and in accordance with HSA guidelines. Ensure it provides proper instructions on how to use the device safely and effectively.

10. Confirm Registration Fees and Payment

• Confirm the registration fees for D-class medical devices with HSA.
• Ensure that payment methods and processes are in place to complete the application.

11. Prepare for HSA Inspection (if applicable)

• Facility Inspection: For high-risk devices, HSA may conduct an inspection of the manufacturing facility as part of the registration process.
• Ensure that the manufacturing facility is compliant with GMP and ready for inspection. Review facility documentation and operational practices to ensure they align with regulatory expectations.

12. Review and Finalize the Application

• Review all documents to ensure completeness and compliance with HSA's regulatory requirements.
• Double-check that all required technical documentation, clinical evidence, risk management plans, and quality management system documents are included in the application.
• If applicable, ensure the authorized representative is listed as the contact for the application.

Summary of Preparatory Work for D-Class Medical Device Registration in Singapore HSA:

1. Understand regulatory requirements and classifications under the Health Products Act.
2. Verify manufacturer details and appoint a local authorized representative if applicable.
3. Establish a Quality Management System (QMS) in compliance with ISO 13485 and GMP.
4. Prepare risk management documentation and gather clinical evidence (if applicable).
5. Ensure compliance with relevant international standards (e.g., ISO 14971, ISO 10993, IEC 60601).
6. Prepare a comprehensive technical file and clinical trial data.
7. Prepare labeling and instructions for use (IFU) in line with HSA guidelines.
8. Plan for post-market surveillance to monitor device safety post-launch.
9. Confirm the registration fee and payment methods.
10. Prepare for a facility inspection by HSA (if necessary).
11. Review and finalize the application before submission.

Proper preparation and comprehensive documentation will increase the likelihood of a smooth and successful application for D-class medical device registration in Singapore.

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