To apply for D-class medical device registration with the Health Sciences Authority (HSA) in Singapore, you must meet specific requirements as outlined by HSA. D-class devices are considered high-risk and are subject to stringent regulatory scrutiny. Below are the key requirements for applying for D-class medical device registration:

1. Classification of the Device

• Confirm D-Class Classification: Ensure that the device is classified as D-class, which refers to high-risk devices (e.g., implantable devices, life-supporting devices, and critical therapeutic devices).
  • The classification is based on the intended use, risk to patients, and the potential impact on health.
  • A device must meet the criteria set out in HSA’s risk classification rules.

2. Appointment of a Local Authorized Representative (AR)

• For Foreign Manufacturers: If the device is manufactured outside Singapore, a Local Authorized Representative (AR) must be appointed to submit the application to HSA.
  • The AR is responsible for ensuring that the device complies with HSA’s regulations and for managing the regulatory communication.
• Role of AR: The AR will submit the registration application on behalf of the foreign manufacturer and serve as the point of contact for HSA.

3. Required Documentation

The following documentation is required for D-class medical device registration:

a) Device Description

• Detailed description of the device, including its intended use, mechanism, and how it operates.
• Technical specifications, design features, and functionality.

b) Risk Management and Risk Assessment

• Risk Management Plan: A detailed risk management document outlining the identified risks associated with the device and how they are mitigated.
• Risk Assessment: This includes an analysis of the risks to patients and users and how these are minimized through the design, materials, and intended use.

c) Clinical Data

• Clinical Evidence: Clinical data must be provided to demonstrate the device's safety and efficacy. This is essential for high-risk devices (D-class).
• Clinical Trials: Depending on the device, clinical trials may be required to provide sufficient evidence.
• Alternative Data: If clinical trials are not available, other scientific evidence (e.g., literature, studies) may be considered, but HSA typically expects strong clinical data for D-class devices.

d) Manufacturing Information

• Detailed information about the manufacturing process, including controls, facilities, and quality assurance systems.
• The manufacturing facilities should adhere to Good Manufacturing Practice (GMP).

e) Quality Management System (QMS) Certification

• The manufacturer must have a Quality Management System (QMS) in place, such as ISO 13485 certification or equivalent.
• QMS certification ensures that the device is manufactured in compliance with international standards for medical devices.

f) Labeling and Instructions for Use (IFU)

• Labeling: The device must have clear, accurate, and compliant labeling.
• Instructions for Use (IFU): Provide detailed instructions on the safe and effective use of the device in English. This should include usage, maintenance, warnings, and any contraindications.

g) Certificate of Free Sale (CFS) (if applicable)

• If the device is sold in other markets, a Certificate of Free Sale (CFS) from the regulatory authority in the country of manufacture may be required. This certifies that the device is legally sold in the country and complies with local regulations.

h) Registration Fees

• Payment of application fees is required for the registration process. The fee is based on the device's classification and other factors.

4. Submission Process via MEDICS

• MEDICS Portal: The application is submitted via HSA’s Medical Device Information and Communication System (MEDICS), an online platform for submitting medical device registration applications.
• Required Information: You will need to submit all the documents mentioned above through the MEDICS portal.
• Local AR Submission: If you are a foreign manufacturer, your appointed Local AR will submit the registration application to HSA.

5. HSA Evaluation

• Review by HSA: HSA will evaluate the submitted documentation to ensure the device meets safety, quality, and regulatory standards.
• Clinical Evidence Review: HSA will carefully assess the clinical data and risk management plans for high-risk devices.
• Possible GMP Inspection: HSA may perform a Good Manufacturing Practice (GMP) inspection at the manufacturing facility to ensure that the device is manufactured according to international quality standards.

6. Post-Submission Clarifications

• During the evaluation process, HSA may request additional information or clarification on specific aspects of the device, such as clinical trials, risk management strategies, or labeling.
• Timely Response: The Local AR must ensure prompt and complete responses to any requests from HSA to avoid delays in the registration process.

7. Approval and Certificate of Registration (COR)

• Approval: If HSA finds that the device complies with all necessary regulations and safety standards, the device will be approved.
• Issuance of COR: Upon approval, HSA will issue a Certificate of Registration (COR), which allows the device to be legally marketed and sold in Singapore.
• Marketing: Once registered, the device can be distributed and used in Singapore.

8. Post-Market Surveillance

• After the device is registered, you must comply with post-market obligations such as monitoring the device’s performance, reporting adverse events, and conducting recalls if necessary.
• Adverse Event Reporting: Report any adverse events or issues with the device to HSA.
• Continuous Compliance: Ensure the device continues to meet all safety and regulatory standards while on the market.

Summary of Key Requirements for D-Class Medical Device Registration in Singapore:

1. Confirm Device Classification: Ensure it is classified as a D-class (high-risk) device.
2. Appoint Local Authorized Representative (for foreign manufacturers).
3. Submit Required Documents:
   • Device Description, Risk Management Plan, Clinical Data, QMS Certification, Manufacturing Information, Labeling and IFU, CFS (if applicable).
4. Pay Registration Fees.
5. Submit Application via the MEDICS online portal.
6. HSA Evaluation of submitted documents and possible GMP inspection.
7. Approval and Certificate of Registration issued by HSA.
8. Post-Market Surveillance to monitor device performance and comply with regulatory obligations.

By fulfilling these requirements, manufacturers can apply for D-class medical device registration in Singapore, ensuring their device meets the regulatory standards set by the Health Sciences Authority.

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