Confirm Device Classification: Ensure that the device is classified as D-class based on the HSA risk classification system. D-class devices are high-risk and may include implantable devices or those intended to support vital life functions.

D-class medical device registration in Singapore under the Health Sciences Authority (HSA) refers to the registration of medical devices that are classified as high risk. These devices typically present a significant potential risk to patients or users, which is why they are subject to more stringent regulatory requirements and scrutiny. D-class devices are required to undergo a more comprehensive review process before they are allowed to be marketed in Singapore.

D-class devices are considered to present a higher risk to patients and must meet stricter regulatory requirements.

The typical time to obtain Class C medical device registration with the Health Sciences Authority (HSA) in Singapore is approximately 3 to 6 months. However, the exact duration may vary depending on several factors, such as the complexity of the device, the completeness of the application, and whether additional information or clarifications are required during the review process.

No, Class C medical device registration with Singapore HSA does not require an annual review. However, there are certain periodic obligations and requirements that manufacturers must adhere to in order to maintain the registration.

Legal Authorization to Market: Registering a Class C medical device with HSA grants the manufacturer legal permission to sell and distribute the device within Singapore. It ensures the device meets the required safety, quality, and performance standards.

The Class C medical device registration process with the Health Sciences Authority (HSA) in Singapore typically takes 3 to 6 months from submission to approval. The timeline can vary depending on several factors, such as the complexity of the device, the completeness of the application, and the need for additional information or clarification during the review process.

Class C medical device registration with the Health Sciences Authority (HSA) in Singapore refers to the regulatory process for medical devices that are classified as medium to high risk. These devices are typically subject to more rigorous safety and performance standards due to their potential impact on patient health and safety.