The D-class medical device registration process with the Health Sciences Authority (HSA) in Singapore is comprehensive due to the high-risk nature of the devices. Below is an overview of the procedures, required materials, and key considerations for applying for D-class medical device registration.

1. Procedures for D-Class Medical Device Registration

Step 1: Classify the Device

• Ensure that your device is correctly classified as a D-class medical device (high-risk).
  • D-class devices include implantable devices, life-supporting or life-sustaining devices, and those with high potential risks to patient safety.

Step 2: Appoint a Local Authorized Representative (AR)

• If you are a foreign manufacturer, appoint a Local Authorized Representative (AR) based in Singapore. The AR will submit the application on your behalf and act as the primary contact for HSA.
• AR Role: The AR must ensure the device complies with HSA regulations, submit the registration documents, and handle all communication with HSA.

Step 3: Prepare the Required Documentation

• Gather and organize the required materials (listed below).
• Ensure all documents meet the regulatory requirements and are in English (or officially translated into English).

Step 4: Submit the Application via MEDICS

• Applications are submitted through the Medical Device Information and Communication System (MEDICS) portal.
  • Access the portal: HSA MEDICS Portal.
  • Create an account (if not already registered) or log in to submit the application.
  • Pay registration fees during the submission process (around SGD 1,070 for D-class devices).

Step 5: HSA Review and Evaluation

• HSA will evaluate the application and submitted documents. This includes reviewing clinical data, risk management plans, and manufacturing practices.
• GMP Inspection: HSA may perform a Good Manufacturing Practice (GMP) inspection of the manufacturing facility if necessary.

Step 6: Respond to Requests for Additional Information

• HSA may request further clarifications or additional documents. Be prepared to provide timely responses to avoid delays in the registration process.

Step 7: Approval and Issuance of Certificate of Registration (COR)

• If HSA is satisfied with the application and documentation, the device will be approved.
• Upon approval, HSA will issue a Certificate of Registration (COR), allowing the device to be marketed and sold in Singapore.

Step 8: Post-Market Surveillance

• After approval, you must adhere to post-market surveillance obligations such as reporting adverse events, conducting recalls (if necessary), and ensuring continued compliance with HSA standards.

2. Required Materials for D-Class Medical Device Registration

The following documents are required to apply for D-class medical device registration in Singapore:

a) Device Information

• Device Description: Detailed description of the device, its intended use, design, and functionality.
• Risk Management Plan: A comprehensive risk management document outlining the device’s risks and how they are mitigated. This includes a Risk Assessment for the device.
• Clinical Evidence: Clinical data to support the safety and efficacy of the device. Clinical trials may be required, depending on the device type.

b) Manufacturing Information

• Manufacturing Process: Detailed information about the manufacturing process, controls, and facilities.
• Good Manufacturing Practice (GMP) Compliance: Documentation showing that the manufacturer adheres to GMP standards. HSA may request a GMP inspection.

c) Quality Management System (QMS)

• ISO 13485 Certification or equivalent: The manufacturer must have a certified Quality Management System in place to ensure the device is produced in accordance with quality standards.

d) Labeling and Instructions for Use (IFU)

• Labeling: All labels must include necessary information such as product name, manufacturer's details, intended use, warnings, and instructions.
• Instructions for Use (IFU): Detailed and clear instructions on how to use the device, including precautions, contraindications, and maintenance guidelines. The IFU must be in English.

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

• If the device is sold in other jurisdictions, 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 that country.

f) Application Form and Registration Fees

• Complete the application form and pay the associated registration fees (approximately SGD 1,070 for D-class devices).

3. Key Considerations for D-Class Medical Device Registration

a) Clinical Data and Risk Management

• Clinical Evidence: D-class devices require strong clinical data to demonstrate safety and efficacy, as they are considered high-risk devices. This may involve clinical trials or evidence from similar devices.
• Risk Management: HSA places significant emphasis on a comprehensive risk management process. You must demonstrate how risks are identified, assessed, and mitigated, especially for high-risk devices.

b) Manufacturing Compliance

• HSA may conduct a Good Manufacturing Practice (GMP) inspection to ensure that the device is being produced in a compliant manner. GMP compliance is critical for D-class devices.

c) Local Authorized Representative (AR)

• If you are a foreign manufacturer, ensure you appoint a qualified and experienced Local Authorized Representative (AR) in Singapore. The AR will be responsible for handling the registration process and post-market compliance.

d) Post-Market Obligations

• After the device is registered, you will have ongoing responsibilities for post-market surveillance. This includes monitoring the device's performance, reporting adverse events, and complying with any corrective actions or recalls.
• You must keep HSA informed of any significant changes to the device or its manufacturing process.

e) Timely Responses

• HSA may request additional information or clarifications during the registration process. Respond promptly and thoroughly to any requests to avoid delays in approval.

f) Fees and Costs

• The application fee for D-class devices is approximately SGD 1,070, but additional costs may arise depending on inspections, Local AR fees, and obtaining QMS certification.

Summary of the D-Class Medical Device Registration Process:

1. Confirm the device classification as D-class (high-risk).
2. Appoint a Local Authorized Representative if you are a foreign manufacturer.
3. Prepare required documentation (clinical data, risk management plans, manufacturing information, labeling, etc.).
4. Submit the application via MEDICS and pay the application fees.
5. HSA Review and Evaluation, including potential GMP inspection.
6. Respond to any requests for additional information from HSA.
7. Approval and Issuance of Certificate of Registration (COR).
8. Post-market surveillance to ensure ongoing compliance and reporting of adverse events.

By carefully following these procedures, ensuring that all required materials are submitted, and addressing key considerations, you can successfully navigate the D-class medical device registration process with HSA in Singapore.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn