To apply for D-class medical device registration with the Health Sciences Authority (HSA) in Singapore, the device must meet certain conditions and regulatory requirements. D-class devices are classified as high-risk medical devices, so they are subject to stricter scrutiny and must meet comprehensive safety and efficacy standards.

Conditions to Apply for D-Class Medical Device Registration in Singapore HSA

1. Device Classification

   • The device must be classified as D-class under the Singapore Medical Device Classification Rules. D-class devices are typically high-risk medical devices that are critical to patient health, such as implantable devices or devices intended to sustain or support life.
   • Classification Criteria: The classification is based on the intended purpose, duration of use, invasiveness, and other factors such as potential for harm. D-class devices require more extensive evidence of safety and efficacy due to the higher risks they pose.

2. Compliance with Regulatory Standards

   • The device must comply with international regulatory standards such as:
     • ISO 13485 (Quality Management System for medical devices)
     • ISO 14971 (Risk management for medical devices)
     • Good Manufacturing Practices (GMP) or equivalent standards (for manufacturing)
   • The manufacturer (or its Authorized Representative, if foreign) must demonstrate adherence to these quality standards in the device development, manufacturing, and post-market phases.

3. Clinical Evidence

   • D-class devices require substantial clinical data demonstrating the device’s safety, effectiveness, and performance for its intended use.
     • This can include results from clinical trials or data from similar devices if clinical trials are not conducted for the device.
     • Clinical Evaluation Report (CER): A detailed report summarizing the clinical data and justifying the device's safety and efficacy.

4. Risk Management

   • The device must have undergone a risk management process in line with ISO 14971 standards.
     • Risk Analysis: The device should have a comprehensive risk analysis report identifying potential hazards and outlining the methods to mitigate these risks.
     • Risk Control Measures: The manufacturer must have implemented measures to minimize any identified risks to patients or users.

5. Good Manufacturing Practice (GMP) Compliance

   • The manufacturing facility of the device must comply with Good Manufacturing Practices (GMP) or an equivalent standard. This ensures that the device is manufactured in a controlled and safe environment.
   • ISO 13485 Certification: The manufacturer must be certified under ISO 13485 or another recognized Quality Management System (QMS).

6. Local Authorized Representative (AR)

   • Foreign Manufacturers: If the manufacturer is based outside Singapore, they must appoint a Local Authorized Representative (AR) in Singapore.
     • The AR will be responsible for submitting the registration application on behalf of the manufacturer and for communication with HSA during the registration process.
     • The AR must submit a Letter of Appointment along with the registration application.

7. Device Labeling and Instructions for Use (IFU)

   • The device must meet labeling requirements established by HSA, including:
     • Product name and description.
     • Manufacturer's contact information.
     • Intended use, contraindications, and warnings.
     • Storage instructions and expiry date (if applicable).
   • The Instructions for Use (IFU) must be comprehensive, clear, and available in English, detailing how to use the device, any warnings, contraindications, and maintenance instructions.

8. Post-Market Surveillance Plan

   • The manufacturer (or AR) must have a post-market surveillance plan in place to monitor the device's performance once it is on the market.
     • This includes procedures for reporting adverse events, conducting recalls, and monitoring the safety and efficacy of the device throughout its lifecycle.

9. Payment of Registration Fees

   • The applicant must pay the registration fee to HSA when submitting the application. For D-class devices, the fee is approximately SGD 1,070. This fee covers the review and processing of the registration application.

10. Regulatory Compliance and Documentation

    • The manufacturer or AR must provide all the required documents in the correct format and in compliance with HSA's regulations. This includes:
      • Device description, clinical data, and clinical evaluation report.
      • Risk management documents (risk analysis, mitigation plans).
      • Manufacturing information and GMP compliance.
      • ISO 13485 certification.
      • Device labeling and IFU.
      • Payment receipt for registration fees.

Summary of Conditions for D-Class Medical Device Registration

1. The device must be classified as a D-class medical device.
2. The manufacturer must comply with ISO 13485 and ISO 14971 standards.
3. Clinical data and a clinical evaluation report must be provided to demonstrate the device’s safety and efficacy.
4. The device must undergo a risk management process to mitigate risks.
5. The manufacturing facility must comply with GMP or equivalent standards.
6. A Local Authorized Representative (AR) is required if the manufacturer is based outside Singapore.
7. The device must meet labeling and IFU requirements.
8. A post-market surveillance plan must be in place.
9. The registration fee must be paid.
10. All required documents must be submitted in the correct format via the MEDICS portal.

By meeting these conditions, manufacturers can apply for D-class medical device registration with HSA in Singapore and ensure their device is in compliance with local regulations.

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