The process for D-class medical device registration with the Health Sciences Authority (HSA) in Singapore involves several steps to ensure that high-risk devices meet the necessary regulatory requirements for safety and efficacy. Here’s an overview of the process and steps involved:

1. Device Classification

• Confirm Device Classification: Ensure that the device is classified as D-class based on the HSA risk classification system. D-class devices are high-risk and may include implantable devices or those intended to support vital life functions.
• Risk Assessment: Devices that fall into D-class are assessed based on their intended use, potential risks, and impact on human health.

2. Appoint a Local Authorized Representative (AR)

• Requirement for Foreign Manufacturers: If you are a foreign manufacturer, you must appoint a Local Authorized Representative (AR) in Singapore. The AR is responsible for submitting the application and communicating with HSA.
• Role of AR: The AR acts as a liaison between the manufacturer and HSA for registration and regulatory compliance.

3. Gather Required Documentation

For D-class medical devices, the following documents are typically required:

• Device Description: Detailed information on the device, its intended use, design, and how it works.
• Risk Management Plan: A risk analysis document showing how the risks associated with the device are mitigated.
• Clinical Data: Clinical evidence demonstrating the safety and effectiveness of the device. For D-class devices, extensive clinical trial data is often required.
• Quality Management System (QMS) Certification: Certification of the manufacturer’s quality management system, typically ISO 13485 or equivalent, which demonstrates adherence to international standards for medical device manufacturing.
• Manufacturing Information: Detailed information about the manufacturing process, controls, and any third-party involvement.
• Labeling and Instructions for Use: The device's labeling, including instructions for use, in English.
• Certificate of Free Sale (CFS): If applicable, a certificate that the device is legally sold in other markets.
• Payment of Application Fee: Proof of payment for the application fee.

4. Submit Application via MEDICS

• Online Portal: The application is submitted through the Medical Device Information and Communication System (MEDICS), which is HSA’s online platform for device registration.
• Required Information: In addition to the documents mentioned above, the application will need to include details about the device, the manufacturer, and the AR (if applicable).
• Local Representative Submission: The AR will submit the application and manage the communication with HSA during the review process.

5. HSA Evaluation Process

• Review of Documentation: HSA will evaluate the submitted documents, focusing on the device's safety, effectiveness, and compliance with regulatory requirements.
• Clinical Evidence: For D-class devices, HSA places a high emphasis on clinical data and may require additional information or more extensive data to ensure the device’s safety and efficacy.
• Manufacturing Inspection: HSA may conduct a Good Manufacturing Practice (GMP) inspection at the manufacturing site to verify compliance with the necessary quality standards.

6. Post-Submission Clarifications

• Additional Information: During the evaluation process, HSA may request further clarification or additional data regarding the device, its clinical trials, risk management, or manufacturing processes.
• Communication with AR: The AR must be responsive to HSA’s requests for further details or documents.

7. Approval and Issuance of Certificate of Registration (COR)

• Approval: If HSA finds the device complies with all the necessary regulations, they will approve the registration.
• Issuance of COR: A Certificate of Registration (COR) is issued, allowing the device to be marketed and sold in Singapore.
• Market Access: Once the COR is issued, you can legally distribute and sell the device in Singapore.

8. Post-Market Obligations

• Ongoing Monitoring: After registration, you must adhere to ongoing regulatory requirements, including:
  • Post-market Surveillance: Monitor the performance of the device once it’s on the market and report any adverse events to HSA.
  • Adverse Event Reporting: If any issues arise with the device after it’s on the market (e.g., safety concerns or malfunctions), these must be reported to HSA.
  • Recalls: If necessary, you must carry out device recalls as part of your post-market obligations.

Summary of Key Steps:

1. Device Classification: Confirm D-class classification.
2. Appoint Local AR: For foreign manufacturers, appoint a local authorized representative in Singapore.
3. Prepare Documentation: Collect device descriptions, clinical data, QMS certification, risk assessments, and labeling.
4. Submit via MEDICS: Submit the application via the HSA online portal (MEDICS).
5. HSA Evaluation: HSA evaluates the device, clinical evidence, and compliance.
6. Approval & COR Issuance: Once approved, receive the Certificate of Registration (COR).
7. Post-Market Surveillance: Comply with post-market obligations, including reporting adverse events and conducting recalls.

Timeframe and Fees

• The timeframe for the registration process can vary depending on the complexity of the device and the completeness of the documentation. Generally, D-class devices require a more thorough review, so the process can take several months.
• Registration fees: There are application fees associated with the registration process, which will depend on the type of device and the classification.

By following these steps, manufacturers can ensure that their D-class medical devices are compliant with the regulations set forth by HSA and can be marketed in Singapore.

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