D-class medical device registration in Singapore under the Health Sciences Authority (HSA) refers to the registration of medical devices that are classified as high risk. These devices typically present a significant potential risk to patients or users, which is why they are subject to more stringent regulatory requirements and scrutiny. D-class devices are required to undergo a more comprehensive review process before they are allowed to be marketed in Singapore.

D-Class Medical Devices

• High-Risk Devices: These devices are usually intended for life-supporting, life-sustaining, or critical therapeutic purposes. They can include implantable devices, devices that monitor or support vital life functions, or devices that pose a significant risk if they fail.
• Examples: Examples may include pacemakers, defibrillators, certain types of diagnostic devices, and other devices that have direct impact on the human body’s most critical systems.

Steps to Apply for D-Class Medical Device Registration in Singapore (HSA)

1. Classify the Device

• Before applying for registration, confirm that your device is classified as D-class according to HSA's risk classification rules.
• The classification is based on factors like the device’s intended use, how it interacts with the human body, and the risks associated with it.

2. Appoint a Local Authorized Representative (AR)

• If you are a foreign manufacturer, you need to appoint a local Authorized Representative (AR) in Singapore. The AR will act as the liaison with HSA for the device registration process.
• The AR is responsible for ensuring that the device meets Singapore's regulatory requirements and submits the application.

3. Prepare the Required Documentation

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

• Device Description: Detailed information about the device, including its design, materials, and intended use.
• Risk Management and Assessment: A risk analysis showing the potential risks of the device and how they are mitigated.
• Clinical Data: Clinical evidence supporting the safety and efficacy of the device. For high-risk devices, HSA may require more extensive clinical trial data.
• Manufacturing Information: Details about the manufacturing process and quality control procedures.
• Quality Management System (QMS) Certification: Typically, you need ISO 13485 certification or equivalent, which demonstrates that the manufacturer adheres to international standards for medical device manufacturing.
• Labeling and Instructions for Use: All labeling materials and instructions for the proper use of the device in English.
• Risk and Benefit Analysis: Supporting data and documentation showing that the benefits of the device outweigh the risks.
• Payment of Application Fee: Evidence of payment for the registration fee.

4. Submit the Application via MEDICS

• The application for registration must be submitted through HSA’s Medical Device Information and Communication System (MEDICS), which is an online portal for the submission of medical device applications in Singapore.
• The local AR will need to log in to this portal to submit the device's registration and accompanying documents.

5. HSA’s Evaluation Process

• Once submitted, HSA will evaluate the device based on the provided documentation. For D-class devices, this evaluation may involve more extensive reviews, especially of clinical data and risk management plans.
• HSA may request additional information or clarification during the review process.
• They may also conduct a Good Manufacturing Practice (GMP) inspection of the manufacturing facilities.

6. Approval and Issuance of Certificate of Registration (COR)

• If HSA finds that the device complies with all regulatory requirements, they will approve the registration and issue a Certificate of Registration (COR).
• This certificate is essential for marketing and selling the device in Singapore.
• After approval, you must also comply with post-market requirements, including reporting adverse events, conducting post-market surveillance, and maintaining the device’s quality.

7. Post-Market Obligations

• After the device is on the market, you will need to ensure continuous compliance with HSA’s regulations, including conducting regular post-market surveillance, handling recalls if necessary, and reporting adverse events.

For D-class devices, the process can take longer due to the thorough evaluation and additional documentation required to prove the device’s safety and efficacy. It is crucial to ensure that all regulatory and quality management systems are in place to meet the requirements of HSA.

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