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

1. Determine the Classification of the Device

• D-class devices are considered to present a higher risk to patients and must meet stricter regulatory requirements.
• Ensure your device falls into this category based on the risk classification guidelines provided by HSA.

2. Appoint a Local Authorized Representative

• If you are a foreign manufacturer, you must appoint a local Authorized Representative (AR) in Singapore to submit the application on your behalf.

3. Prepare Required Documents

You will need to prepare several documents for the registration process, including:

• Device Description: Detailed information about the device, its intended use, and how it works.
• Risk Assessment: A document assessing the risks associated with the device.
• Clinical Data: Provide clinical evidence demonstrating the device's safety and effectiveness.
• Quality Management System (QMS): Certification (such as ISO 13485) indicating your device is manufactured under a quality system that meets international standards.
• Labeling and Instructions for Use: The device labeling and instructions for use in English.
• Manufacturing Information: Manufacturing and quality control process details.
• Registration Fees: Proof of payment for application fees.

4. Submit the Application via the Medical Device Information and Communication System (MEDICS)

• Log into HSA's MEDICS system, an online portal used for submitting medical device registration applications.
• Submit all the required documents electronically.

5. Evaluation by HSA

• HSA will review the submitted documents to ensure compliance with regulatory standards.
• Additional information or clarification may be requested during this process.
• For higher-risk devices, additional clinical data or evidence may be needed to demonstrate safety and efficacy.

6. Approval and Registration

• If the application meets all requirements, HSA will issue a Certificate of Registration (COR), which allows you to market the device in Singapore.
• Ensure compliance with post-market surveillance and adverse event reporting obligations once the device is on the market.

7. Post-market Obligations

• After registration, the device must be monitored for safety and performance.
• Any adverse events or device recalls must be reported to HSA.

Ensure you comply with all local regulations and guidelines throughout the process.

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