The process for A-class medical device registration with the Health Sciences Authority (HSA) in Singapore involves several key steps, from initial device classification to submission, review, and post-registration obligations. Below is a detailed outline of the process and the steps involved in the registration of A-class medical devices.

1. Device Classification

Before registering a medical device in Singapore, the first step is to determine its classification. Medical devices are classified into four classes (A, B, C, D) based on the risk associated with the device. A-class devices are considered low risk.

• A-class devices do not require clinical trials or extensive pre-market approval. They are subject to self-certification by the manufacturer, meaning that the manufacturer is responsible for ensuring compliance with regulatory requirements.

2. Prepare Required Documentation

After confirming that the device is an A-class medical device, manufacturers must prepare the necessary documentation for registration. The required documents typically include:

1. Device Description: A detailed description of the device, including its intended use, design, and functionality.

2. Labeling Information: Labels, instructions for use (IFU), and any other documentation that will accompany the device when sold or distributed.

3. Conformity Assessment: A statement confirming that the device complies with relevant regulatory standards, such as:

   • ISO 13485 (Quality Management System for medical devices).
   • ISO 14971 (Risk management for medical devices).

4. Manufacturer Information: Details about the manufacturer, including name, address, and other relevant contact information. If the manufacturer is based outside Singapore, an Authorized Representative (AR) must be identified.

5. Risk Management File: Evidence of a risk assessment conducted in accordance with ISO 14971, identifying and mitigating risks associated with the device.

6. Clinical Evidence (if applicable): While not typically required for A-class devices, clinical evidence or performance data may be requested if the device’s safety or performance is in question.

7. Declaration of Conformity: A self-declaration that the device meets all necessary regulatory requirements.

3. Submit the Application

Once all required documentation is prepared, the next step is to submit the application to HSA for device registration. The application process involves:

• Online Submission: Applications must be submitted via the HSA’s Medical Device Regulatory System (MDRS), an online portal where all medical device registrations are processed.
• Required Information: Ensure that all the required documentation is uploaded, including product information, certificates (e.g., ISO certifications), and manufacturer details.

4. HSA Review

After submission, HSA will review the application to ensure it meets regulatory requirements. The steps involved in HSA’s review include:

1. Document Verification: HSA verifies that the submitted documents comply with the necessary regulatory standards.
2. Risk Assessment: Even for low-risk A-class devices, HSA may review the device’s risk management file to ensure that potential risks have been adequately addressed.
3. Device Classification Confirmation: HSA will confirm whether the device correctly falls under the A-class category or if a reclassification is needed.
4. Evaluation of Labeling: The labeling and packaging are also assessed to ensure they meet the required standards.

If additional information or clarification is needed, HSA may request the manufacturer to provide further documentation or amend the submitted information.

5. Receive Approval and Registration

Once HSA is satisfied with the documentation and the device complies with all regulatory requirements:

• Approval Issuance: HSA will grant approval for the device to be registered in Singapore. The device will be entered into the Singapore Medical Device Register (SMDR).

• Device Registration Number: Upon approval, the device will be issued a unique registration number. This number should be included on the device’s labeling and documentation for traceability.

6. Post-Registration Obligations

After the device is registered, there are ongoing obligations that the manufacturer must comply with to maintain market access. These obligations include:

1. Post-Market Surveillance: Manufacturers must establish a system for monitoring the safety and performance of the device once it is on the market. This involves:

   • Reporting any adverse events or device malfunctions to HSA.
   • Maintaining a complaints handling system.

2. Adverse Event Reporting: If any adverse events or safety issues arise, the manufacturer must report them to HSA within the required timeframes (usually 15 days for serious adverse events).

3. Annual Registration Renewal: Although A-class devices generally don’t require re-evaluation or additional clinical trials, the manufacturer must renew the device’s registration annually and pay the required registration fees.

4. Device Labeling Compliance: The manufacturer must ensure that the device’s labeling and packaging remain compliant with HSA’s regulatory requirements.

5. Maintain Conformity: If there are any changes to the device or manufacturing process (e.g., changes in design, intended use, or risk assessment), the manufacturer must submit an update to HSA for review and approval.

7. Handling Changes or Recalls

If there are any modifications to the device after registration (e.g., changes in design, materials, or intended use), HSA must be notified, and updated documentation may need to be submitted for review.

• Device Recalls: In the event of a device recall, the manufacturer must inform HSA and implement the necessary corrective actions.
• Field Safety Corrective Actions (FSCA): If there is a safety concern related to the device, the manufacturer must initiate corrective actions, which may include a recall or distribution stop, and report these actions to HSA.

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