To apply for A-class medical device registration with the Health Sciences Authority (HSA) in Singapore, you will need to follow specific steps and use the official platform, Regulatory Information Management System (RIMS). Here's an overview of the process, requirements, and where to apply.

Steps to Apply for A-Class Medical Device Registration with Singapore HSA

Step 1: Ensure Device Classification

Before applying, make sure your device qualifies as an A-class medical device under HSA's classification criteria. A-class devices are considered low-risk and typically involve non-invasive devices that do not pose significant risks to patient safety or health.

• You can refer to the HSA Medical Device Classification Guidelines to determine whether your device qualifies as A-class. If in doubt, you can contact HSA to request a classification determination.

Step 2: Appoint a Local Authorized Representative (for Foreign Manufacturers)

If you are a foreign manufacturer, you must appoint a local Authorized Representative (AR) in Singapore who will handle the registration process on your behalf. The AR is responsible for submitting your device application to HSA and ensuring compliance with local regulations. Local manufacturers do not need an AR.

• The AR must be a registered entity with HSA and should be well-versed in the regulatory process.

Step 3: Prepare Required Documents

Prepare the necessary documentation to support your device's application. The key documents typically include:

1. Device Description: Detailed description of the device, its intended use, and design.
2. Labeling and Instructions for Use (IFU): The product label and user instructions.
3. Risk Management File: Risk analysis and safety management data.
4. Conformity Assessment Documentation: ISO certifications, Declaration of Conformity.
5. Manufacturer Information: Manufacturer’s name, contact information, and manufacturing site details.
6. Clinical Data (if applicable): Clinical evidence if required (usually not for A-class devices).

Step 4: Create an Account on the RIMS Portal

To submit an application, you must have access to HSA’s Regulatory Information Management System (RIMS). RIMS is the online portal for submitting medical device applications to HSA.

1. Create an Account: Visit the RIMS portal and create a user account if you don’t already have one.

   • For foreign manufacturers, your Authorized Representative (AR) in Singapore will need to create an account and submit the application on your behalf.

   RIMS Portal Link

2. Log in to the Portal: Once your account is set up, log in to the RIMS portal to start the application process.

Step 5: Complete the Application Form

In the RIMS portal, you will need to fill out the online application form, which asks for:

• Basic details of the device (e.g., name, intended use, classification).
• Manufacturer and AR information (if applicable).
• Device classification and other regulatory information.

Ensure that all fields are completed accurately to avoid delays.

Step 6: Upload Required Documents

After completing the application form, you will be asked to upload all required documents (as listed above) through the RIMS portal. These documents may include:

• Device description, risk management information, labeling, and IFU.
• Certificates and any other supporting documents (e.g., ISO certificates, clinical data, etc.).

Make sure that all documents are in English or officially translated into English, as HSA requires all documentation in the English language.

Step 7: Pay the Registration Fee

Once your application is complete, you will need to pay the registration fee through the RIMS portal. The fee for A-class devices typically ranges from SGD 500 to SGD 1,000.

The payment can be made via the available online payment methods in the portal.

Step 8: Submit the Application

After paying the registration fee, submit the application. The RIMS portal will confirm submission, and you can track the status of your application through the portal.

Step 9: HSA Review and Approval

HSA will review your application and documents. If all requirements are met, HSA will issue a Certificate of Registration for the A-class device. This certificate allows the device to be marketed and sold in Singapore.

• Timeframe: The review process for A-class devices is usually quicker than for higher-class devices. It typically takes a few weeks to a couple of months, depending on the completeness of your submission.

Step 10: Post-Market Surveillance

Once your device is registered, you are required to comply with post-market surveillance requirements. This includes monitoring the device’s performance, reporting adverse events, and maintaining regulatory compliance.

Where to Apply

All applications for A-class medical devices must be submitted through HSA's Regulatory Information Management System (RIMS).

• Platform: RIMS Portal (RIMS Login)

• For Foreign Manufacturers: Your Authorized Representative (AR) in Singapore will submit the application on your behalf through RIMS. Make sure that your AR is registered with HSA and has access to RIMS.

Key Points to Remember

1. Device Classification: Make sure your device is classified correctly as an A-class device. A-class devices are low-risk and typically non-invasive.
2. Authorized Representative (AR): Foreign manufacturers need to appoint a local AR in Singapore to handle the submission.
3. RIMS Portal: All submissions must be made through the official RIMS portal. Ensure you create an account or work with your AR to submit the application.
4. Documentation: Provide accurate and complete documentation, including device descriptions, labeling, risk assessments, and certifications.
5. Fee Payment: The registration fee must be paid online through the RIMS portal.

By following these steps and submitting the required documents, you can successfully apply for A-class medical device registration with HSA in Singapore.

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