Requirements for Applying for A-Class Medical Device Registration with Singapore HSA

To apply for the registration of an A-class medical device with the Health Sciences Authority (HSA) in Singapore, you must meet several regulatory requirements. A-class medical devices are considered low-risk, non-invasive devices. The process involves submitting documentation that demonstrates compliance with HSA’s regulatory standards. Below are the key requirements for applying:

1. Device Classification

• Ensure A-Class Qualification: The device must be classified as A-class according to HSA's classification rules. A-class devices are typically low-risk, non-invasive, and generally include items such as bandages, thermometers, and simple medical tools.
• You can refer to HSA’s Medical Device Classification guidelines to ensure that your device meets the A-class criteria.

2. Appointment of a Local Authorized Representative (if applicable)

• For foreign manufacturers: If your company is based outside Singapore, you must appoint a Local Authorized Representative (AR) in Singapore. The AR is responsible for submitting the registration application on your behalf, communicating with HSA, and ensuring that the device complies with regulatory requirements.
• For domestic manufacturers: If you are based in Singapore, you do not need to appoint an AR.

3. Documentation for Application

You will need to provide a set of required documents that demonstrate the device’s safety, quality, and compliance with applicable standards:

A. Device Information and Description

• Device Description: A comprehensive description of the medical device, including its intended purpose, design, and how it functions.
• Risk Assessment: An analysis of potential risks associated with the device, including how they are mitigated. This may involve basic hazard identification, risk management, and safety measures.

B. Labeling and Instructions for Use (IFU)

• Labels: All labels on the device and its packaging must include the device name, manufacturer details, and any required warnings or handling instructions.
• Instructions for Use (IFU): A document that provides clear instructions on how to use the device safely. The IFU should include:
  • Device description.
  • Intended use and indications.
  • Contraindications (if applicable).
  • Warnings, precautions, and adverse effects.
  • Proper storage and disposal information

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