To register and apply for A-class medical device registration with Singapore Health Sciences Authority (HSA), you need to follow a specific set of steps and procedures. Here's a detailed guide on how to proceed with the registration process:

Steps for Registering A-Class Medical Devices with Singapore HSA

1. Confirm the Classification of the Device

First, confirm that your device is correctly classified as A-class. A-class devices are considered low-risk and generally include products such as bandages, surgical gloves, and non-invasive diagnostic devices. If you're unsure of the classification, you can consult HSA to confirm whether your device qualifies as A-class.

2. Appoint an Authorized Representative (AR) (If Applicable)

• If you are a foreign manufacturer (i.e., the manufacturer is based outside Singapore), you must appoint an Authorized Representative (AR) in Singapore.
• The AR will handle the registration process and communications with HSA on your behalf. This is a mandatory requirement for foreign manufacturers. If you are a local manufacturer, this step is not necessary.

3. Prepare the Required Documentation

You will need to gather and prepare the necessary documentation to submit with your application. The documents required for A-class medical device registration with HSA typically include the following:

• Device Description: A detailed description of the device, including its intended use, indications, and basic functioning.
• Manufacturer Information: Information about the manufacturer, including its name, address, and contact details.
• Labeling and Instructions for Use (IFU): The device’s labeling (which includes the device’s name, batch number, expiration date, and any other required labeling information) and the instructions for use.
• Risk Management File: A risk management assessment in accordance with ISO 14971, which identifies any potential risks associated with the device and the measures taken to mitigate those risks.
• Conformity Assessment: A declaration of conformity to relevant international standards, such as ISO 13485 (Quality Management System for Medical Devices).
• Certificate of Free Sale (if applicable): A certificate from the country of origin indicating that the device is freely sold in that country.
• Product Test Reports (if applicable): For certain devices, you may need to submit product performance or safety testing reports to demonstrate compliance with standards.

4. Create an Account on the HSA MDRS Portal

To submit the registration application, you will need to create an account on the HSA Medical Device Regulatory System (MDRS) portal. This portal is the platform through which all applications for medical device registration are submitted and managed.

• Visit the HSA MDRS Portal: HSA MDRS Portal
• Sign up and register: Create an account if you don’t already have one. Make sure to keep your login credentials secure for future use.

5. Submit the Application via HSA MDRS Portal

Once your account is set up, follow these steps to submit your application for A-class medical device registration:

• Log in to the MDRS Portal: Use your registered credentials to access the portal.
• Complete the Application Form: Fill out the online application form with the details of your medical device, including the product description, manufacturer details, and classification (A-class).
• Upload Supporting Documents: Upload all required documentation, including the device description, risk management file, labeling, and conformity assessment.
• Pay the Application Fee: You will need to pay a registration fee when submitting the application. The payment is made directly through the MDRS Portal.

6. HSA Review and Evaluation

After submission, HSA will begin reviewing the application. Since A-class devices are low-risk, the review process is typically quicker compared to higher-risk devices. HSA will evaluate:

• Completeness of the Application: Ensuring all necessary documents are submitted and complete.
• Labeling Compliance: Ensuring the device’s labeling complies with the regulatory requirements.
• Risk Management and Safety: Reviewing the risk management file to ensure that the device’s risks are identified and properly mitigated.
• Conformity with Standards: Verifying that the device complies with international standards like ISO 13485 (quality management) and ISO 14971 (risk management).

7. HSA Decision and Registration Approval

If HSA finds the application and documentation in order, they will:

• Approve the Registration: If everything is in compliance with the regulatory requirements, HSA will issue an approval.
• Assign a Registration Number: HSA will assign a unique registration number to the device, which must be displayed on the product’s labeling.
• List in the Singapore Medical Device Register (SMDR): The device will be added to the official Singapore Medical Device Register as a registered device.

8. Post-Registration Requirements

Once your device is registered, you must ensure ongoing compliance with HSA’s post-market surveillance requirements:

• Post-Market Surveillance: You are required to monitor the device's safety and effectiveness after it is on the market. This includes reporting any adverse events or device malfunctions.
• Adverse Event Reporting: If any serious adverse events or safety concerns occur, you must report them to HSA within the specified timeframe (typically 15 days for serious adverse events).
• Annual Registration Renewal: You must renew your device’s registration annually to maintain its active status in the Singapore Medical Device Register (SMDR).
• Device Modifications: If there are any changes to the device (e.g., changes in design, manufacturing process, labeling), you must notify HSA and, in some cases, submit a new application for review.