Steps and Process for Registering A-Class Medical Devices with Singapore HSA

Registering an A-class medical device with the Health Sciences Authority (HSA) in Singapore involves several key steps, from classification to submission. Below is an outline of the steps and process:

Step 1: Determine the Device Classification

• Classify the Device: Before you begin, ensure that your medical device qualifies as an A-class device under HSA’s classification rules. A-class devices are low-risk, non-invasive, and generally include items like bandages, thermometers, and low-risk diagnostic devices.

Step 2: Appoint a Local Authorized Representative (if applicable)

• Foreign Manufacturers: If you are located outside Singapore, you must appoint a Local Authorized Representative (AR) in Singapore. This representative will handle all interactions with HSA and ensure your device complies with local regulatory requirements.
• Domestic Manufacturers: If your company is based in Singapore, this step is not necessary.

Step 3: Prepare Required Documentation

You will need to prepare and submit a set of documents to HSA. The specific requirements may vary depending on the device, but generally include the following:

1. Device Description:

   • A detailed description of the device, including its intended purpose and how it works.
   • Indications for use and contraindications (if applicable).

2. Device Labeling:

   • Product labels, Instructions for Use (IFU), and other materials to ensure that the device is used safely. This includes:
     • Device name and model.
     • Manufacturer's details.
     • Usage instructions in English.
     • Storage, handling, and disposal information.

3. Conformity Assessment:

   • A Declaration of Conformity stating that the device complies with relevant standards, such as ISO 13485 (Quality Management System).
   • This may include other certificates such as CE marking, depending on the device.

4. Manufacturer Information:

   • Information about the device manufacturer, including the name, address, and a summary of their quality management system.

5. Clinical Evaluation (if applicable):

   • For A-class devices, clinical data is usually not required unless the device makes specific medical claims (e.g., diagnostic devices may require clinical evidence).
   • If clinical data is necessary, provide the relevant clinical evaluation to demonstrate safety and effectiveness.

6. Risk Assessment:

   • A risk analysis to ensure that the device meets safety and performance standards. This is a general requirement for all medical devices.

Step 4: Submit Application via RIMS Portal

1. Create an Account on RIMS: Register on the Regulatory Information Management System (RIMS) portal. This is the HSA's online platform used for all medical device registrations.

2. Complete the Application:

   • Once you’re logged into the RIMS portal, complete the online application form. This will involve entering information about the device and uploading all required documentation (as listed in Step 3).

3. Pay the Registration Fee:

   • A fee is required to process the registration. For A-class medical devices, the fee is usually lower compared to higher-risk classes. The exact fee can be found on the HSA website.

4. Submit for Review: After completing the application and paying the fee, submit it for HSA’s evaluation. HSA will review the application to ensure the device meets regulatory requirements.

Step 5: HSA Evaluation

• Review Process: HSA will review the submission to verify that the device complies with local regulatory requirements. This review typically focuses on the following:

  • Risk classification.
  • Documentation accuracy.
  • Compliance with labeling and conformity assessment requirements.

• For A-class devices, the evaluation process is usually straightforward and faster compared to higher-risk devices (Classes B, C, or D). Since A-class devices are low-risk, they are generally subject to less stringent scrutiny.

• Request for Additional Information: If necessary, HSA may request additional information or clarification regarding the application.

Step 6: Issuance of Certificate of Registration

• Successful Registration: Once HSA has evaluated the application and determined that the device complies with regulatory standards, they will issue a Certificate of Registration.
  • This certificate allows you to legally sell and market the device in Singapore.
• Certificate Validity: The registration is typically valid for 5 years. After that, the device may need to be re-registered or renewed.

Step 7: Post-Market Surveillance

After registration, there are several post-market obligations that you must comply with:

1. Adverse Event Reporting: You must report any adverse events or device defects to HSA promptly.
2. Post-Market Monitoring: Ensure that the device is performing as intended and address any complaints or incidents.
3. Periodic Updates: You may need to provide updated information on the device or its manufacturing process if there are changes.

Key Points to Keep in Mind:

• Low-Risk Classification: A-class devices are considered low risk and generally have a faster registration process.
• Local Authorized Representative (AR): Foreign manufacturers must appoint an AR in Singapore to handle the registration process.
• RIMS Portal: All applications must be submitted through the RIMS portal, which is HSA’s online system for medical device registrations.
• Fees: Registration fees vary depending on the classification of the device. A-class devices typically have lower fees.
• Post-Market Obligations: Once registered, you must monitor the device's performance and report any adverse events.

Conclusion

Registering an A-class medical device with HSA involves ensuring your device qualifies as low-risk, submitting required documentation via the RIMS portal, and undergoing HSA’s evaluation. Once registered, the device can be marketed in Singapore, with ongoing post-market surveillance required.

For the most up-to-date information and detailed guidance, it’s always recommended to check the HSA website or consult directly with HSA or a regulatory expert.

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