No, A-class medical device registration with the Health Sciences Authority (HSA) in Singapore does not require annual review. However, the registration does have a validity period, and certain obligations remain throughout the life cycle of the device.

Key Points Regarding A-Class Medical Device Registration:

1. Registration Validity:

   • Once your A-class medical device is successfully registered with HSA, the registration is typically valid for 5 years.
   • After this period, you will need to renew the registration, but there is no requirement for an annual review or re-assessment during this time unless there are changes to the device or regulatory requirements.

2. Renewal Process:

   • The renewal process will require you to submit an application before the registration expires. It usually involves verifying that the device is still compliant with HSA regulations, but no annual review is necessary.
   • The renewal process can generally be done through the HSA’s Medical Device Regulatory System (MDRS) portal.

3. Post-Market Obligations:

   • Although annual reviews are not required, you are obligated to conduct post-market surveillance of the device throughout its lifecycle.
   • This includes monitoring the safety and performance of the device, reporting any adverse events or device failures, and ensuring that your device remains compliant with HSA’s quality management and risk management standards (such as ISO 13485 and ISO 14971).

4. Updates and Modifications:

   • If there are significant changes to your device, such as a change in manufacturing process, labeling, or intended use, you will need to notify HSA and potentially submit an updated registration application.
   • If your device undergoes substantial modifications, it may be subject to additional reviews, but these are event-based and not part of an annual review cycle.

5. Inspection or Audits:

   • In certain circumstances, HSA may conduct inspections or request additional documentation if there are concerns related to your device’s safety or compliance. However, these are not routine or annual; they occur as needed based on post-market surveillance findings or issues raised.

Summary:

• No annual review is required for A-class medical devices in Singapore.
• The registration is valid for 5 years, after which it must be renewed.
• Post-market surveillance is required to monitor safety and efficacy.
• Changes or updates to the device may require additional submissions to HSA, but this is not part of a regular review cycle.

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