To apply for Class B medical device registration with the Health Sciences Authority (HSA) in Singapore, follow these key steps:

1. Determine the Classification

Ensure that your device is classified as Class B based on its intended use and risk profile according to the HSA classification rules.

2. Appoint an Authorized Representative

If you are a foreign manufacturer, you need to appoint a local authorized representative (LAR) in Singapore. The LAR is responsible for handling regulatory matters on your behalf with HSA.

3. Prepare the Required Documentation

The following documents are typically required for Class B medical device registration:

• Product Registration Form (for Class B devices)
• Device Description (including intended use, user manual, and device specifications)
• Conformity Assessment Documentation (CE marking or other certification, depending on your device's market approval)
• Risk Management Report (compliant with ISO 14971 or equivalent standard)
• Clinical Evaluation Report (if applicable, especially for devices with high clinical risks)
• Quality Management System Certificate (e.g., ISO 13485 certificate)
• Labeling Information (including device labeling and packaging information)
• Free Sale Certificate or Manufacturing Certificate from the regulatory authority in the country of origin
• Other Supporting Documents (e.g., test reports, performance data, or other relevant documentation)

4. Submit the Application

Submit your registration application via the Health Products Regulation System (HPRS) on the HSA website. You will need to create an account in HPRS if you haven't already done so.

• Fill in the details of the device and upload the required documentation.
• Pay the applicable application fee. Fees for Class B devices are generally lower than for higher classes, but the exact cost depends on the specifics of the device.

5. HSA Evaluation

After submission, HSA will evaluate the registration application. This includes reviewing the documentation to ensure compliance with the regulatory requirements. The evaluation process for Class B devices generally takes 1-3 months, but it may vary depending on the completeness of the submission and the complexity of the device.

6. Receive Registration Approval

If the application meets all the requirements, HSA will issue a Certificate of Registration for your device. You are now authorized to place the device on the market in Singapore.

7. Post-Market Surveillance

After registration, you must comply with HSA’s post-market surveillance requirements, which include monitoring the safety and performance of the device once it is on the market. This includes reporting any adverse events or issues related to the device.

Timeline and Fees:

• Timeline: The registration process typically takes 1 to 3 months, depending on the device and completeness of your application.
• Fees: The registration fee for Class B devices is generally lower than for higher-class devices. Fees vary, so it’s best to check the current fee schedule on the HSA website.

Key Points:

• Ensure your device is classified correctly according to HSA’s classification rules.
• Ensure that all supporting documents, such as conformity certificates, clinical evaluations, and labeling, are in order before submission.
• Monitor the post-market performance of the device and comply with HSA’s requirements for market surveillance.