The time cycle for registering an A-class medical device with the Health Sciences Authority (HSA) in Singapore is generally relatively short due to the low-risk nature of these devices. However, the exact duration can depend on several factors, such as the completeness of your application, HSA's current workload, and the accuracy of the information provided.

Typical Time Frame for A-Class Medical Device Registration

• Preparation Time: Preparing the necessary documentation can take several weeks, depending on how quickly you can gather and compile all required information (device description, labeling, risk management documentation, etc.).

• HSA Review Time: Once the application is submitted, the review process for A-class devices is typically 4 to 6 weeks. Since A-class devices are low-risk, the review is generally quicker compared to higher-risk devices (Class B, C, D). HSA will primarily review the documentation, device classification, and compliance with regulatory standards (e.g., ISO 13485, ISO 14971).

Key Steps in the Time Cycle

1. Document Preparation (Variable Time):
   • Preparing the device description, risk management documentation, labeling, and other supporting materials can take time depending on your internal processes and readiness. This step is outside HSA's timeline but should be considered part of the overall process.
2. Online Submission via MDRS Portal (1-2 Days):
   • The time it takes to submit the application through the HSA Medical Device Regulatory System (MDRS) portal is relatively short, typically 1-2 days once all documents are ready and you have created your account on the portal.
3. Review and Evaluation by HSA (4-6 Weeks):
   • A-class devices typically undergo a straightforward review since they are low-risk. The HSA will check:
     • Completeness of the application
     • Compliance with regulatory requirements
     • Labeling and risk management documents
   • If the documents are complete and in order, HSA will generally approve the device within 4 to 6 weeks.
4. Approval and Registration Issuance (1-2 Weeks):
   • After approval, HSA will issue the registration number for the device, and it will be listed in the Singapore Medical Device Register (SMDR).
   • This typically takes 1 to 2 weeks after the review process is complete.

Total Time Estimate

• Average Total Time: 5 to 8 weeks from the submission of the application to receiving approval and registration for an A-class medical device.

Factors That Could Affect the Timeline:

1. Completeness of Application: If HSA requires additional information or if the application is incomplete, it could delay the process.
2. HSA's Workload: During periods of high submission volume, HSA may take longer to review applications.
3. Clarifications or Modifications: If there are any issues or clarifications needed after the initial submission, this may extend the review time.

Summary of Time Cycle for A-Class Device Registration

• Preparation of Documents: Variable (usually several weeks, depending on how quickly documentation is gathered)
• Application Submission: 1-2 days (after documents are ready)
• HSA Review and Evaluation: 4-6 weeks (for A-class devices)
• Approval and Registration Issuance: 1-2 weeks
• Total Estimated Time: 5 to 8 weeks

By keeping your application complete and accurate, you can help ensure that the A-class medical device registration process is as efficient as possible.

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