When applying for Class B medical device registration with the Health Sciences Authority (HSA) in Singapore, you must meet several regulatory requirements to ensure the device complies with local standards and is safe for use. Below are the key requirements you need to meet:

1. Device Classification

• Class B devices are categorized as low- to moderate-risk medical devices. These devices do not present a high risk to patients or users and typically include products like non-invasive diagnostic tools, basic medical devices, or personal health products.
• You must ensure that your device is correctly classified under Class B. If you are unsure, you can request a classification ruling from HSA.

2. Local Authorized Representative (LAR)

• Foreign Manufacturers must appoint a Local Authorized Representative (LAR) based in Singapore to submit the registration application on their behalf.
• The LAR will handle communications with HSA and ensure compliance with Singapore's regulations. The LAR must be a company or entity registered with HSA.
• Requirement: The LAR is responsible for:
  • Submitting the application via the Health Products Regulation System (HPRS).
  • Maintaining post-market surveillance and regulatory compliance.

3. Regulatory Compliance

• Conformity with Relevant Standards: You must demonstrate that your device meets the relevant safety, quality, and performance standards. This is often accomplished by:
  • ISO 13485 (for Quality Management Systems).
  • ISO 14971 (for Risk Management).
  • Other applicable standards depending on the device type.
• If your device has been approved in other jurisdictions (e.g., CE-marking, FDA approval, etc.), you must provide evidence of that approval or conformity.

4. Documentation Requirements

You must submit comprehensive documentation for HSA’s evaluation, including the following:

1. Product Registration Form (via HPRS): An online form with details about the device, including:

   • Device name and description.
   • Manufacturer’s details.
   • Intended use.
   • Classification and justification.

2. Device Description: A detailed description of the device, including:

   • The device's intended use and function.
   • Materials and components.
   • How it operates and interacts with users.

3. Declaration of Conformity: A statement confirming that the device complies with relevant regulatory standards. For devices that have been CE-marked or FDA-approved, you must provide the CE certificate or FDA clearance.

4. Risk Management Report: A risk assessment report in accordance with ISO 14971, detailing how risks associated with the device are identified, evaluated, and mitigated.

5. Clinical Evaluation Report (if applicable): A report summarizing clinical data demonstrating the device’s safety and effectiveness. This may be required for clinical devices or if the device is novel.

6. Quality Management System (QMS) Certificate: A certificate confirming compliance with ISO 13485, or an equivalent standard. This ensures that the manufacturer has a robust quality management system in place.

7. Free Sale Certificate: A certificate from the regulatory authority in the country of origin confirming that the device is legally marketed in that jurisdiction.

8. Labeling and Instructions for Use (IFU): Documentation that clearly explains how the device is used, any risks involved, and includes necessary warnings and instructions.

9. Other Supporting Documents: Depending on the nature of the device, you may need to submit additional documents such as:

   • Biocompatibility Test Reports (for devices that come into contact with the human body).
   • Sterilization Validation (if the device is sterilized).
   • Performance Testing Data (for diagnostic devices or other performance-sensitive products).

5. Risk Classification Justification

• You must justify why the device is classified as Class B. This typically involves demonstrating that the device poses low or moderate risk to patients or users, using established classification criteria.
• If your device involves new or untested technology, you may need to provide more detailed risk analysis and supporting data.

6. Compliance with Labeling Requirements

• The device labeling and Instructions for Use (IFU) must meet HSA’s regulatory requirements. This includes:
  • The name of the device and its intended use.
  • Manufacturer details (company name and address).
  • Country of origin.
  • Serial or batch numbers.
  • Warnings, contraindications, and precautions.
  • Directions for use.
  • Compliance with ISO 15223 or relevant international standards for medical device labeling.

7. Post-Market Obligations

• Post-market surveillance is essential for ensuring the ongoing safety and effectiveness of the device once it is on the market. You are required to monitor the device's performance and report any adverse events to HSA.
• If issues arise with the device (e.g., defects or adverse events), the manufacturer and LAR must act promptly to address these concerns, which may include issuing recalls or providing corrective actions.

8. Registration Fee

• There is an application fee for Class B medical device registration, which is typically between SGD 1,000 and SGD 2,000. The exact fee depends on the specifics of the device. The fee must be paid via the HPRS portal at the time of application submission.

9. Compliance with Local Regulations

• Ensure compliance with all relevant Singaporean medical device regulations as outlined by HSA. This includes meeting specific standards for the safety, quality, and performance of the device.
• Be prepared for regular post-market reporting and audits to maintain compliance.

Key Points to Remember:

• Local Authorized Representative: If you are a foreign manufacturer, you must appoint an LAR to submit the application on your behalf.
• HPRS Portal: All applications must be submitted through the Health Products Regulation System (HPRS).
• Documentation: Be thorough and ensure all documentation is complete, accurate, and in the required format.
• Regulatory Compliance: Meet local and international standards for safety, performance, and risk management.
• Fee Payment: Pay the registration fee via the HPRS portal during submission.

By ensuring that all the above requirements are met and preparing the necessary documents, you will be able to apply for Class B medical device registration with HSA in Singapore effectively.

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