The process and procedure for applying for Class C medical device registration with Singapore's Health Sciences Authority (HSA) involves several steps. These steps ensure that the device meets regulatory requirements for safety, quality, and performance before being marketed in Singapore. Here's a detailed guide on how to apply:

Step-by-Step Process for Class C Medical Device Registration with Singapore HSA

1. Confirm Device Classification

• Class C Classification: Class C medical devices are those that are considered medium-to-high risk. Examples include devices that are implantable, life-supporting, or used in critical applications. The classification is based on the intended use, duration of contact, and invasiveness of the device.
• Self-Classification: Verify that your device falls into Class C. If unsure, you can seek clarification from HSA or consult a regulatory expert.

2. Appoint a Local Authorized Representative (LAR)

• Foreign Manufacturers: If your company is located outside Singapore, you are required to appoint a Local Authorized Representative (LAR) who will act as the liaison between your company and HSA.
• LAR Role: The LAR is responsible for submitting the registration application, handling communications with HSA, and ensuring compliance with local regulatory requirements.

3. Prepare Necessary Documentation

You need to compile and submit several documents to HSA for the registration process. These include:

• Device Information:
  • Detailed description of the device (intended use, functionality, design).
  • Technical specifications and materials used.
• Manufacturing Information:
  • Information about the manufacturer’s site (including certifications like ISO 13485 or GMP).
  • Evidence of adherence to Good Manufacturing Practice (GMP).
• Clinical Evidence:
  • Provide clinical trial data or clinical performance studies, if required.
  • Evidence of safety and performance data, including any studies that show the device’s safety and effectiveness.
• Risk Management:
  • A risk management report based on ISO 14971.
  • Identify potential risks associated with the device and describe the methods used to mitigate them.
• Labeling and Instructions:
  • Device labels, packaging, and instructions for use (IFU) that meet HSA’s guidelines.
• Declaration of Conformity:
  • A statement from the manufacturer confirming that the device complies with relevant international standards (e.g., ISO 13485, CE Marking, or FDA approval).
• Quality Management System:
  • Proof that the manufacturer follows an approved quality management system, such as ISO 13485.
• Declaration of Compliance with Safety Standards:
  • Provide evidence that the device meets international standards (e.g., IEC 60601 for electrical safety).

4. Submit Application via HSA Online Portal

• Create an Account:
  • Create an account on the HSA online registration portal (HSA’s Medical Device Branch portal).
• Complete the Application:
  • Fill out the registration application form with the required details (e.g., device classification, intended use, and manufacturer information).
• Upload Documents:
  • Upload all necessary documentation (device information, clinical data, labeling, and other required documents).
• Pay Fees:
  • Pay the applicable registration fees. The fee structure depends on the device and its classification.
• Submit the Application:
  • Once all the required documents are uploaded and fees are paid, submit the application for review.

5. HSA Review and Evaluation

• Initial Review:
  • HSA will check that all required documents have been submitted and that the device meets the regulatory requirements.
• Technical Evaluation:
  • HSA will assess the safety, performance, and clinical evidence of the device.
• Possible Request for Additional Information:
  • HSA may request additional documents or clarifications during the evaluation process. If so, provide the requested information in a timely manner.
• Manufacturing Site Inspection:
  • HSA may conduct a site inspection of the manufacturing facility to ensure compliance with GMP or quality management systems.

6. Approval and Registration

• Issuance of Registration Certificate:
  • If the application meets all regulatory requirements, HSA will approve the registration of the Class C medical device.
• Validity:
  • The device will be registered for 5 years from the approval date. After 5 years, a renewal application must be submitted for continued market access.

7. Post-Market Surveillance and Reporting

• Post-Market Surveillance:
  • After the device is registered and marketed in Singapore, you must comply with post-market surveillance requirements, including monitoring the device’s performance and reporting any adverse events.
• Adverse Event Reporting:
  • Manufacturers and importers are required to report any adverse events, product defects, or complaints to HSA.
• Periodic Updates:
  • Ensure that device information, labeling, and instructions are kept up to date and compliant with any changes in regulatory requirements.

Additional Considerations

• Regulatory Consultants: You may want to hire a regulatory consultant to assist in the preparation of the application, especially for more complex devices.
• Clinical Evaluation: If clinical evidence is not readily available, HSA may require you to conduct clinical trials or submit data from equivalent devices.

Timeline

• The processing time for Class C medical device registration can vary but typically takes several months. It can take from 3 to 6 months for HSA to review and approve the application, depending on the complexity of the device and the completeness of the submission.

By following these steps, your Class C medical device can be successfully registered with HSA and made available in the Singapore market. If you need further guidance on any part of the process, feel free to reach out!

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