The time cycle for applying for A-class medical device registration with the Health Sciences Authority (HSA) in Singapore is relatively short compared to higher-risk device classes, as A-class devices are considered low risk. However, the exact time required for the application and review process depends on several factors, including the completeness of the application and HSA's workload. Below is an overview of the general time cycle and the review steps.

Review Steps Involved in the A-Class Medical Device Registration Process

The review process for A-class devices follows a relatively straightforward path due to their low-risk classification. The key steps HSA takes during the review include:

1. Preliminary Screening

• Initial Check: When the application is received, HSA will perform an initial review to ensure that all required documentation is complete and correctly submitted. This includes checking for any missing information or inconsistencies.
• Verification of Documentation: Ensure that all the required documents (e.g., device description, labeling, quality management system certification, etc.) are included.

2. Document Verification

• Technical and Regulatory Compliance: HSA verifies that the device meets relevant regulatory standards and requirements. For A-class devices, this includes confirming that the manufacturer has provided sufficient documentation related to:
  • Conformity to ISO 13485 (Quality Management System for medical devices).
  • Compliance with ISO 14971 (Risk management).
  • Proper labeling and packaging in accordance with Singapore’s regulatory requirements.
• Risk Assessment: HSA reviews the risk management file submitted as part of the application to ensure that the device has been adequately assessed for safety and effectiveness.

3. Confirmation of Classification

• Risk Classification: Even though A-class devices are considered low risk, HSA will ensure that the device is correctly classified. If HSA believes the device poses higher risks than initially indicated, they may reclassify it into a higher category (e.g., B, C, or D), which could require additional documentation or clinical data.

4. Labeling and Claims Evaluation

• Review of Labeling: HSA will evaluate the device’s labeling to ensure it complies with the required standards. This includes assessing the information provided on the label, the instructions for use (IFU), and any other product-related documentation that will accompany the device.
• Claims and Advertising: HSA also checks that any claims made in the labeling or marketing materials are substantiated and compliant with regulations.

5. Device Performance and Safety Evaluation

• Evaluation of Safety and Performance: For A-class devices, extensive clinical trials are typically not required, but HSA may review any available performance data or literature. If any performance issues or concerns arise, HSA may request further clarification or testing data.

6. Final Review and Decision

• Approval/Denial Decision: Once all documentation has been reviewed and verified, HSA will make a decision on whether to approve the device for registration.
  • Approval: If the device meets all regulatory requirements, HSA will issue an approval, and the device will be registered in the Singapore Medical Device Register (SMDR).
  • Denial: If any significant issues are identified (e.g., inadequate safety data or non-compliance with labeling requirements), HSA may deny the application or ask for additional documentation.

7. Issuance of Registration Number

• Notification of Registration: Upon approval, the manufacturer will receive a registration number that must be included on the device’s labeling. This number confirms the device’s official registration in Singapore and provides traceability.
• Communication with the Manufacturer: HSA will notify the manufacturer (or their Authorized Representative) of the outcome via the HSA MDRS portal. If the registration is approved, the manufacturer can then proceed with marketing and distributing the device in Singapore.

Factors That Can Impact the Timeline

While A-class devices are typically processed quickly, several factors can influence the timeline:

• Completeness of the Application: Incomplete or incorrect documentation can delay the process, as HSA may need additional information or clarifications.
• HSA Workload: During periods of high demand or when there is a backlog of applications, the review time might extend slightly.
• Changes in Regulatory Requirements: If there are any recent changes to the regulatory framework that affect your device, additional time may be required to comply with the new requirements.

Conclusion

The process for A-class medical device registration with HSA in Singapore is relatively streamlined due to the low-risk nature of these devices. The review cycle typically lasts around 4 to 6 weeks, with 30 days being the standard review time for most applications. Manufacturers should ensure that all required documentation is complete and correct to avoid delays. HSA will evaluate the documentation, confirm the classification, review labeling, and assess device safety before granting registration.

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