The process for registering a D-class medical device with the Health Sciences Authority (HSA) in Singapore involves several steps to ensure the safety, performance, and compliance of the device. D-class devices are classified as low-risk medical devices under Singapore's Medical Device Regulations and generally follow a streamlined registration process.

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

1. Determine the Device Classification

• Device Classification: Before proceeding, confirm that the device is classified as Class D under the Singapore Medical Device Regulations. Class D devices are typically considered low-risk devices and may include general medical equipment, non-invasive devices, or simple diagnostics.
• Classification Criteria: Devices are classified based on their intended use, the risk associated with their use, and other factors outlined in the Medical Device Regulations.

2. Appoint an Authorized Representative (If Applicable)

• If you are a foreign manufacturer, you must appoint a local authorized representative (AR) in Singapore to handle the registration process on your behalf. This representative should be an entity based in Singapore with expertise in medical device regulation.
• If you are a local manufacturer, this step is not required.

3. Prepare Required Documentation

• Gather the required technical documentation that demonstrates the safety and performance of the device. This typically includes:
  • Device Description: Detailed information about the device, including its design, function, and intended use.
  • Risk Management: A risk assessment of the device according to ISO 14971 or similar standards.
  • Manufacturing Information: Documentation regarding the manufacturing process, including quality control measures, compliance with ISO 13485 (if applicable), and good manufacturing practices (GMP).
  • Clinical Data: Evidence supporting the safety and efficacy of the device based on clinical studies or pre-market data (if applicable).
  • Labels and Instructions for Use (IFU): Device labeling and clear instructions for users.
  • Post-Market Surveillance Plan: Plan for monitoring the device's performance and safety once it is on the market.

4. Submit the Registration Application

• Submit the registration application via the HSA's Medical Device Registration System (MedReg), which is an online portal for managing the registration process.
• Include all the necessary documentation along with your application, ensuring that the information is accurate and up to date.
• Review Application: HSA will review the submitted application and may request additional information or clarifications during the evaluation process.

5. HSA Evaluation and Assessment

• Evaluation of Technical Documentation: HSA will assess the device's technical documentation, including the risk management file, clinical data (if applicable), and manufacturing processes.
• Assessment of Compliance: HSA will verify that the device complies with the Medical Device Regulations, ISO standards, and other relevant requirements.
• Approval or Request for Additional Information: If the device complies with the necessary regulations, HSA will approve the registration. If further information is required, HSA may issue a request for additional documentation or clarifications.

6. HSA Approval and Issuance of Certificate

• Once the evaluation is complete, and the device is found to be compliant, HSA will issue a Certificate of Registration for the device. This certificate confirms that the device is legally authorized for sale in Singapore.
• Registration Number: A unique registration number will be assigned to the device, which must be used for identification in future communications with HSA.

7. Post-Approval Obligations

• After the device is approved, manufacturers must comply with post-market obligations, including:
  • Post-Market Surveillance (PMS): Ongoing monitoring of the device’s safety and performance in the market.
  • Reporting Adverse Events: Prompt reporting of any adverse events or product defects to HSA.
  • Periodic Updates: Submit regular updates regarding the device's status, including renewal applications every 5 years, if applicable.
  • Recalls and Corrective Actions: If necessary, implement corrective actions or recalls and report them to HSA.

8. Renewal of Registration

• Registration Renewal: D-class device registration is valid for 5 years. To continue marketing the device after the initial 5-year period, you must apply for renewal before the registration expires.
• Renewal will involve submitting updated documentation, including post-market surveillance data, any changes to the device, and any corrective actions taken.

Summary of the D-Class Medical Device Registration Process in Singapore (HSA):

1. Classify the Device: Confirm the device classification (D-class).
2. Appoint Authorized Representative (if applicable).
3. Prepare Technical Documentation: Gather device descriptions, risk management documentation, clinical data, manufacturing information, labeling, and IFU.
4. Submit the Application: Apply via HSA's MedReg portal with all required documents.
5. HSA Evaluation: HSA reviews the application and technical documentation.
6. Approval and Issuance of Certificate: HSA approves the device and issues a Certificate of Registration.
7. Post-Approval Obligations: Comply with post-market surveillance, adverse event reporting, and periodic updates.
8. Renewal: Submit renewal applications every 5 years to maintain registration.

By following these steps and ensuring compliance with HSA regulations, you can successfully register your D-class medical device and maintain its status in the Singapore market.

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