To apply for A-class medical device registration with the Health Sciences Authority (HSA) in Singapore, you need to use the Regulatory Information Management System (RIMS), which is HSA’s online platform for submitting medical device applications. Here are the steps to apply:

Where to Apply:

• Platform: The application for registering an A-class medical device is done through the RIMS Portal, which is HSA’s official system for managing regulatory submissions for medical devices in Singapore.

Steps to Apply via the RIMS Portal:

1. Create a RIMS Account:

   • To begin the registration process, you need to create an account on the RIMS Portal. If you do not have an account, visit the RIMS login page and register for one.
   • If you are a foreign manufacturer, ensure that your local Authorized Representative (AR) in Singapore has access to RIMS and can submit the application on your behalf.

   RIMS Portal Link

2. Log In to RIMS:

   • Once registered, log in to the RIMS system using your credentials.
   • If you are an Authorized Representative (AR), ensure that you have the necessary permissions to submit applications on behalf of the manufacturer.

3. Complete the Application Form:

   • In RIMS, select the appropriate category for A-class medical devices under the medical device registration section.
   • Complete the required fields with the information about your device. This includes basic details such as the device name, intended use, manufacturer details, and classification.
   • Upload the required supporting documents, such as:
     • Device description and technical documentation.
     • Labeling and Instructions for Use (IFU).
     • Conformity assessment evidence (e.g., ISO 13485 certification).
     • Risk assessment and clinical data (if applicable).

4. Pay the Application Fee:

   • After completing the application, you will be required to pay the registration fee. The fee can typically be paid online through the RIMS platform using a credit card or other available payment methods.
   • The fee for A-class devices is typically SGD 500 to SGD 1,000.

5. Submit the Application:

   • Once you have filled in all the information and uploaded the necessary documents, submit the application through the RIMS portal.

6. Monitor the Application Status:

   • After submission, you can monitor the status of your application through the RIMS portal.
   • HSA will review the application and may contact you if further information is needed.

7. Issuance of Certificate:

   • If your application is approved, HSA will issue a Certificate of Registration, and you will be allowed to legally market the device in Singapore.

Important Notes:

• If you are a foreign manufacturer, you must appoint a local Authorized Representative (AR) in Singapore. The AR will handle the submission and communication with HSA.
• Make sure that all documents are in English, as HSA requires English-language documentation for the registration process.
• RIMS is the only platform through which medical device applications are processed by HSA, so all registrations must be submitted via this system.

For more detailed guidance, you can refer to the official HSA website and consult their guidelines for medical device registration.

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