To apply for D-class medical device registration in Singapore with the Health Sciences Authority (HSA), you must follow a clear process to ensure that your device meets regulatory requirements. The process involves several steps, including preparing necessary documents, submitting the application, and waiting for approval. Below is a detailed step-by-step process:

Step-by-Step Process for D-Class Medical Device Registration in Singapore HSA

1. Confirm Device Classification

• Class D devices are considered low-risk medical devices. Ensure that your device is properly classified as Class D according to the Medical Device Regulations in Singapore.
• If unsure about the classification, you can seek advice from HSA or consult the classification rules in the Medical Device Regulations.

2. Appoint an Authorized Representative (if applicable)

• Foreign Manufacturers: If you are based outside of Singapore, you must appoint a local authorized representative (AR) in Singapore. This representative will handle all registration-related activities on your behalf.
• Local Manufacturers: If you are based in Singapore, this step is not necessary, and you can apply directly to HSA.

3. Prepare the Required Documentation

To register a D-class medical device, you need to prepare comprehensive technical documentation demonstrating the device’s safety, performance, and compliance with regulatory standards. The documents required generally include:

• Device Description: Details about the device, its intended use, and how it works.
• Manufacturing Information: This includes the manufacturer’s quality management system (e.g., compliance with ISO 13485), manufacturing practices, and the production process.
• Risk Management File: A risk management plan outlining how the device is designed to mitigate risks and comply with ISO 14971 standards.
• Clinical Data (if applicable): Evidence supporting the safety and effectiveness of the device, especially if it involves clinical risks or invasive elements.
• Labeling and Instructions for Use (IFU): Product labels and detailed instructions for use that meet HSA’s requirements.
• Post-Market Surveillance Plan: A plan outlining how the device’s performance will be monitored once it is marketed, including handling adverse events and complaints.

4. Submit the Application

• Log in to the MedReg system, HSA’s online portal for medical device registration.
• Complete the registration application form, which includes:
  • Device Details: Name, classification, and manufacturer details.
  • Authorized Representative (if applicable): Information about your local authorized representative.
• Upload the supporting documents you have prepared, such as technical documentation, labeling, and any clinical data if needed.

5. HSA’s Evaluation

• HSA will begin evaluating the submission upon receiving your application. The evaluation process typically takes 1-3 months, depending on the complexity of the device and the completeness of the submitted information.
• What HSA Reviews:
  • The technical documentation, ensuring it meets the safety and performance standards.
  • Risk management documentation, ensuring compliance with ISO 14971.
  • Any other relevant data to confirm the device meets Singapore's regulatory standards.
• During this process, HSA may request additional information or clarifications if necessary.

6. Issuance of Certificate of Registration

• Once HSA completes the evaluation and confirms that your device meets regulatory standards, they will issue a Certificate of Registration.
• Registration Number: A unique registration number will be assigned to your device, which must be referenced in any future correspondence with HSA.
• Approval Notification: After approval, the device is legally authorized for sale and distribution in Singapore.

7. Post-Market Obligations

After receiving approval, you must comply with post-market obligations to ensure ongoing safety and regulatory compliance:

• Post-Market Surveillance: Monitor the device’s performance and report any adverse events to HSA.
• Periodic Renewals: The registration is valid for 5 years, and you must submit a renewal application before the registration expires.
• Adverse Event Reporting: Report any adverse events or device defects promptly to HSA as part of ongoing vigilance.

Summary of the Process

1. Confirm Device Classification as D-class.
2. Appoint an Authorized Representative (for foreign manufacturers).
3. Prepare Required Documentation (device description, risk management, clinical data, labeling, etc.).
4. Submit the Application via the MedReg System.
5. HSA’s Evaluation of the submitted documents.
6. Issuance of Certificate of Registration once approved.
7. Post-Approval Compliance including post-market surveillance and renewals.

By following these steps and ensuring that all documentation is complete and accurate, you can successfully apply for D-class medical device registration with the Health Sciences Authority (HSA) in Singapore.

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