To apply for D-class medical device registration with the Health Sciences Authority (HSA) in Singapore, follow these steps:

Steps to Apply for D-Class Medical Device Registration in Singapore HSA:

1. Confirm the Device Classification

• Class D medical devices are considered low-risk devices and typically do not require extensive clinical data or a detailed regulatory pathway.
• Ensure that the device is indeed classified as a Class D device according to the Medical Device Regulations in Singapore.

2. Appoint an Authorized Representative (If Applicable)

• If you are a foreign manufacturer, you must appoint a local authorized representative (AR) in Singapore. The AR will submit the registration application and handle all communication with HSA on your behalf.
• Local manufacturers do not need an authorized representative.

3. Prepare the Required Documentation

Gather the necessary technical documentation to support the registration application:

• Device Description: Details about the device, including its intended use, specifications, and design.
• Risk Management File: Risk analysis, including a risk management plan and evidence of compliance with ISO 14971.
• Clinical Data (if applicable): Evidence of safety and efficacy based on clinical studies or pre-market data (if required).
• Manufacturing Information: Quality control measures, including compliance with ISO 13485 (Quality Management System for Medical Devices), GMP standards, and information on the manufacturing process.
• Labels and Instructions for Use (IFU): Ensure the labeling complies with regulatory standards, including product description, intended use, warnings, and proper instructions for safe use.
• Post-Market Surveillance Plan: A plan for monitoring the device's performance and safety once it is in the market.

4. Submit the Application

• Log in to MedReg System: Submit the registration application via the MedReg System, the HSA’s online platform for medical device registration.
• Complete the Application Form: Provide necessary details like device classification, manufacturer information, and authorized representative details (if applicable).
• Attach Supporting Documents: Upload all the required technical documentation along with your application.

5. HSA Evaluation

• Review and Assess: HSA will review the submitted application and the technical documentation for completeness and compliance with Singapore’s medical device regulations.
• Possible Requests for Additional Information: If HSA finds discrepancies or requires additional details, they may ask for clarification or further documentation.
• Evaluation Timeline: The review and evaluation process typically takes 1-3 months.

6. Certificate of Registration Issuance

• If the application is successful and the device meets regulatory standards, HSA will issue the Certificate of Registration.
• Registration Number: A unique registration number will be assigned to the device for tracking and reference.
• Authorized for Sale: Once registered, the device is legally allowed to be marketed and sold in Singapore.

7. Post-Approval Requirements

After approval, you must comply with post-market obligations:

• Post-Market Surveillance: Monitor the device’s safety and performance.
• Adverse Event Reporting: Report any adverse events related to the device to HSA.
• Periodic Renewals: D-class device registrations are valid for 5 years. You must apply for renewal before the registration expires.

Where to Apply

• MedReg System: All registration applications must be submitted through the MedReg System, which is the official online portal for HSA.

Key Considerations:

• Ensure compliance with local standards (e.g., labeling requirements, quality management systems).
• Accurate Documentation: Ensure all technical documentation is complete and accurate to avoid delays.
• Post-Market Compliance: After registration, continue monitoring and reporting the device’s performance to comply with regulations.

By following these steps and ensuring all required documentation is in place, you can successfully apply for D-class medical device registration with the Health Sciences Authority (HSA) in Singapore.

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