When registering an A-class medical device with the Health Sciences Authority (HSA) in Singapore, the process involves several stages: determining the device's classification, preparing documentation, submitting the application through the Regulatory Information Management System (RIMS), and complying with post-market obligations.

Platform: The application for registering an A-class medical device is done through the RIMS Portal, which is HSA’s official system for managing regulatory submissions for medical devices in Singapore.

The cost for registering an A-class medical device with the Health Sciences Authority (HSA) in Singapore can vary based on factors such as the type of device and the applicant's circumstances (e.g., whether you are a local manufacturer or using a local Authorized Representative). However, general fee information is available.

To apply for the registration of an A-class medical device with the Health Sciences Authority (HSA) in Singapore, you must meet several regulatory requirements. A-class medical devices are considered low-risk, non-invasive devices. The process involves submitting documentation that demonstrates compliance with HSA’s regulatory standards.

Classify the Device: Before you begin, ensure that your medical device qualifies as an A-class device under HSA’s classification rules. A-class devices are low-risk, non-invasive, and generally include items like bandages, thermometers, and low-risk diagnostic devices.

A-Class medical devices are the lowest risk category of medical devices as per the Health Sciences Authority (HSA) of Singapore. These devices are generally simple and do not pose significant risk to patients or users when used according to instructions.

A-class medical devices are low-risk devices. They typically require less rigorous regulatory oversight.

The time it takes to obtain A-class medical device registration with the Saudi Food and Drug Authority (SFDA) generally ranges from 4 to 12 weeks. However, the exact duration depends on various factors, including the completeness of your application and the SFDA's review process.