When applying for Class C medical device registration with the Health Sciences Authority (HSA) in Singapore, the device must meet several conditions to comply with HSA's regulatory requirements. These conditions ensure the device's safety, quality, and efficacy. Here are the key conditions that need to be met:

Conditions to be Met for Class C Medical Device Registration:

1. Classification of the Device as Class C:

   • The device must be correctly classified as Class C, which is for medium to high-risk medical devices. Class C devices generally have a significant potential risk to patients, and therefore require more stringent regulatory oversight.
   • Class C devices may include implantable devices, devices for long-term use, or those that come into contact with critical parts of the body.
   • Ensure that the classification is justified based on the device's intended use and risk profile.

2. Compliance with Essential Principles of Safety and Performance:

   • The device must meet the Essential Principles of Safety and Performance as outlined by the HSA.
   • The manufacturer should demonstrate that the device meets these principles through risk management processes and appropriate safety testing.
   • Evidence should be provided that the device performs as intended and does not pose any undue risks to the patient.

3. Good Manufacturing Practice (GMP) Compliance:

   • The manufacturer must comply with Good Manufacturing Practices (GMP), typically demonstrated through certification like ISO 13485, which ensures that the device is manufactured under controlled conditions that guarantee quality.
   • If the manufacturer is located outside Singapore, they must have a valid GMP certification from a recognized body.

4. Clinical Evidence of Safety and Performance:

   • For Class C devices, clinical evidence is required to prove that the device is safe and effective.
   • The clinical evidence may include:
     • Clinical trial data, if available.
     • Clinical evaluation reports that summarize the evidence of safety and performance based on clinical studies or literature reviews.
     • Equivalence data, if the device is similar to other devices already approved.
   • If clinical trials are not available, sufficient literature or data supporting the device's performance should be provided.

5. Risk Management Documentation (ISO 14971 Compliance):

   • The manufacturer must perform a risk assessment in accordance with ISO 14971 to identify, evaluate, and mitigate potential risks associated with the device.
   • A risk management report detailing the process should be submitted, showing how the device’s risks have been minimized to an acceptable level.

6. Quality Management System (QMS) Certification:

   • The manufacturer must have an effective Quality Management System (QMS) in place that complies with international standards such as ISO 13485.
   • The QMS ensures consistent product quality and control over the entire manufacturing process.
   • A copy of the ISO 13485 certification, along with audit reports, should be submitted if available.

7. Compliance with HSA's Labeling Requirements:

   • The device must have clear and accurate labeling that meets the HSA's regulatory requirements.
   • The labeling must include important information, such as the device’s intended use, warnings, contraindications, and instructions for use (IFU).
   • It must also contain information in English and follow the specific format outlined by HSA, including details about the manufacturer, intended use, and any required warnings or cautions.

8. Post-Market Surveillance (PMS) Plan:

   • A Post-Market Surveillance (PMS) plan must be in place to monitor the device’s performance once it is marketed and used by patients.
   • This plan should include mechanisms for vigilance (reporting adverse events or device failures), monitoring the device in the field, and recalling the device if necessary.

9. Regulatory Compliance Documents:

   • Declaration of Conformity (DoC): A statement from the manufacturer confirming that the device complies with relevant regulations.
   • International Certifications: If the device is already marketed in other regions (such as Europe or the U.S.), provide certificates like the CE mark or FDA approval.
   • Technical File: A detailed technical file that includes all necessary documents (including design, manufacturing processes, clinical data, and labeling) should be available and ready for inspection.

10. Local Authorized Representative (LAR):

    • If the manufacturer is located outside Singapore, a Local Authorized Representative (LAR) must be appointed to submit the application on behalf of the manufacturer.
    • The LAR will act as the liaison between the HSA and the foreign manufacturer and will handle all communications regarding the registration process.

11. Payment of Registration Fees:

    • The manufacturer (or LAR) must pay the applicable registration fees for Class C medical devices, which typically range from SGD 3,000 to SGD 5,000.
    • Fees are payable online via the HSA's MDR portal upon submission of the application.

Additional Considerations:

• Device Stability and Performance Testing: If relevant, you should submit data on the stability, performance, and reliability of the device, especially if the device will be used over an extended period or implanted.
• Regulatory Changes: Stay updated on any regulatory changes or additional requirements set by HSA, as regulations for medical devices may evolve over time.

Meeting these conditions ensures that the medical device complies with HSA's safety, performance, and regulatory standards, allowing for smooth registration. If you need further guidance on specific requirements or documentation, feel free to ask!

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