A-class medical device registration with the Health Sciences Authority (HSA) in Singapore refers to the regulatory process for registering low-risk medical devices that are intended for use in Singapore's healthcare system. A-class devices are typically those that pose a minimal risk to patients and users. These devices do not require extensive pre-market review or clinical data, making the registration process relatively straightforward compared to higher-risk medical devices (Class B, C, and D).

What Does A-Class Mean?

In the context of medical device classification, devices are categorized into four classes (A, B, C, D) based on the level of risk they present to patients, users, and the public. The HSA follows the Medical Device Regulation (MDR) to determine which class a device belongs to.

• A-class (low risk): Devices that pose a low risk to patient safety and health. These are typically non-invasive devices with minimal or no contact with the body, such as:
  • Bandages
  • Non-invasive diagnostic tools (e.g., thermometers, stethoscopes)
  • Surgical gloves
  • Walking aids
  • Certain types of dental products

Regulatory Requirements for A-Class Medical Devices

Because A-class devices are low-risk, the regulatory requirements for registration with the HSA are relatively simple. However, the manufacturer or Authorized Representative (AR) still needs to comply with certain standards to ensure the safety and performance of the device. Here are the key features of A-class medical device registration:

1. Simpler Documentation and Requirements

• A-class devices typically do not require clinical data or extensive safety testing.
• The manufacturer needs to provide basic documentation, such as:
  • Device description and intended use
  • Manufacturer’s information (name, address, etc.)
  • Risk management documentation (according to ISO 14971)
  • Quality management system (typically ISO 13485 certification)
  • Labeling and instructions for use (IFU)

2. Shorter Review Process

Since A-class devices are low-risk, the review process is typically faster than for higher-risk devices. The HSA evaluates the submission based on documentation and compliance with relevant standards.

3. Registration and Listing in the Singapore Medical Device Register (SMDR)

• Once the device is registered, it will be listed in the Singapore Medical Device Register (SMDR). This list includes all medical devices authorized for sale in Singapore.
• The device will receive a unique registration number that must appear on the product's labeling and packaging.

4. Post-Market Surveillance

After the device is approved, the manufacturer is responsible for:

• Post-market monitoring of the device’s safety and performance.
• Reporting adverse events or device malfunctions to the HSA.
• Annual renewal of the device’s registration to maintain active listing.

Why Register A-Class Devices with HSA?

• Compliance: It ensures that the device complies with local regulations and is authorized for use in Singapore.
• Market Access: Devices that are registered with HSA are permitted to be marketed and sold in Singapore.
• Trust and Safety: The registration process provides a layer of confidence that the device meets certain safety and quality standards, even for low-risk products.

Summary of A-Class Device Registration

• Low Risk: A-class devices are low-risk, non-invasive, and typically do not involve clinical data or complex testing.
• Simple Documentation: Requires basic documentation like device description, labeling, and risk management documentation.
• Shorter Review: The review process is quicker compared to higher-risk devices.
• Post-Market Responsibilities: Continuous monitoring of the device's safety and performance after it is on the market.

Examples of A-Class Medical Devices:

• Surgical instruments that are non-invasive (e.g., scalpels, scissors)
• Patient monitoring devices that are non-invasive (e.g., blood pressure cuffs)
• Personal protective equipment (e.g., masks, gloves)
• Basic diagnostic tools (e.g., thermometers, stethoscopes)

By registering an A-class device with the HSA, manufacturers can legally market their device in Singapore while ensuring that the device is safe and effective for its intended use.

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