Class B Medical Device Registration with HSA in Singapore

In Singapore, medical devices are classified based on their risk level, which is determined by the Health Sciences Authority (HSA). The classification system is aligned with international guidelines such as the Global Harmonization Task Force (GHTF) and the ASEAN Medical Device Directive (AMDD).

Class B medical devices are low to moderate risk devices. These devices typically pose a lower risk to patients and users when compared to Class C and D devices, but still require regulatory oversight to ensure their safety and efficacy.

Examples of Class B Medical Devices

Some typical Class B devices may include:

• Non-invasive devices (e.g., thermometers, stethoscopes)
• Non-invasive diagnostic equipment
• Some surgical instruments with minimal risk
• Reusable medical instruments with limited contact with the patient

Steps to Apply for Class B Medical Device Registration with HSA

To apply for registration of a Class B medical device with the HSA, follow these key steps:

1. Determine the Classification

First, ensure that your device is correctly classified as Class B. This is based on the intended use and the risk it presents to the patient. If in doubt, you can consult HSA’s classification guidelines or seek advice on how to classify your device.

• Class A: Low risk
• Class B: Low to moderate risk
• Class C: High risk
• Class D: Very high risk

If your device is correctly classified as Class B, you will proceed with the registration process.

2. Appoint an Authorized Representative (if applicable)

If you are a foreign manufacturer (i.e., not based in Singapore), you must appoint a local authorized representative (LAR) in Singapore. This individual or company will be responsible for managing your registration process and liaising with HSA on your behalf.

• Local Authorized Representative (LAR) must be registered with HSA and have the necessary capabilities to manage regulatory responsibilities.

3. Prepare Required Documentation

You need to prepare and submit the following documents as part of your Class B medical device registration:

• Product Registration Form for Class B devices
• Device Description: Information about the device, its intended use, and its key features.
• Risk Management Report: A report that follows the ISO 14971 standard or an equivalent, describing how risks associated with the device have been identified and mitigated.
• Conformity Assessment: Documentation that shows your device complies with international standards (e.g., CE marking, FDA approval, or other recognized regulatory bodies).
• Clinical Evaluation Report: If the device involves clinical testing or has high clinical risk, you will need a report demonstrating the clinical evidence supporting the device’s safety and effectiveness.
• Quality Management System (QMS) Certificate: For example, ISO 13485 certification, demonstrating that the manufacturer adheres to recognized quality management practices.
• Free Sale Certificate: A certificate from the country where the device is marketed or manufactured, verifying that the device is legally sold in that jurisdiction.
• Labeling and Instructions for Use: The device label and the instructions for use (IFU), which must comply with HSA's regulatory requirements.
• Declaration of Conformity (if applicable): A formal declaration stating that the device conforms to the relevant regulatory requirements.

4. Submit the Application

The application for Class B medical device registration is submitted through the Health Products Regulation System (HPRS), an online portal provided by HSA.

• Create an HPRS account if you don’t already have one.
• Complete the online form and upload all required documents, including the supporting certificates and test reports.
• Pay the applicable registration fee (the fee structure can be checked on the HSA website).

5. HSA Evaluation

Once your application is submitted, HSA will begin evaluating the device. The evaluation process involves checking the documentation for completeness and compliance with regulatory standards. This typically includes:

• Review of the technical documentation.
• Assessment of the risk management and clinical evaluation reports.
• Verification that the device meets the essential safety and performance requirements.

Timeline for Approval: The evaluation process for Class B devices typically takes 1 to 3 months, depending on the complexity of the device and the quality of the submitted documentation.

6. Approval and Registration

If the application meets all requirements, HSA will issue a Certificate of Registration for your Class B medical device. This certificate allows you to market the device in Singapore.

7. Post-Market Surveillance and Reporting

After registration, you must comply with HSA’s post-market surveillance requirements, which include:

• Monitoring the safety and performance of the device in the market.
• Reporting any adverse events or product recalls to HSA promptly.
• Keeping HSA informed of any changes in the device’s safety profile or intended use.

Key Considerations for Class B Registration

• Risk Classification: It is critical that your device is accurately classified. Class B devices are considered low to moderate risk, but certain factors, such as how invasive the device is or the complexity of the technology, can affect classification.

• Compliance with International Standards: For Class B devices, it is common to have international regulatory approval (e.g., CE mark, FDA approval) that helps demonstrate conformity to safety and performance standards. HSA will generally accept international certifications as part of the registration process.

• Labeling and Instructions for Use: HSA has specific requirements for how devices should be labeled, including the inclusion of certain regulatory symbols and safety information.

Fees and Timelines

• Fees: Class B devices generally incur moderate registration fees, which are lower than those for Class C and D devices. The exact fee depends on the specifics of the device, and you can refer to HSA’s fee schedule.

• Registration Timeline: The process typically takes 1-3 months, but this may vary based on the complexity of the device and the completeness of your submission.