The cost and time for applying for Class C medical device registration with Singapore's Health Sciences Authority (HSA) can vary based on factors like the complexity of the device and whether all required documentation is in order.

Foreign Manufacturers: If you are a foreign manufacturer, you must appoint a Local Authorized Representative (LAR) based in Singapore. The LAR will be responsible for submitting the registration application to HSA and acting as the point of contact for regulatory matters.

The process and procedure for applying for Class C medical device registration with Singapore's Health Sciences Authority (HSA) involves several steps. These steps ensure that the device meets regulatory requirements for safety, quality, and performance before being marketed in Singapore.

In Singapore, medical devices are classified into four classes (A, B, C, D) based on their risk level. Class C medical devices are considered medium- to high-risk products and typically require more stringent regulatory oversight than Class A and B devices. These devices are associated with a higher potential risk to patient health and safety due to factors like their intended use, duration of use, or the critical nature of their function.

Verify if your medical device falls under Class C based on its risk profile. Class C devices are higher-risk and usually require more extensive documentation.

The time it takes to obtain Class B medical device registration with the Health Sciences Authority (HSA) in Singapore typically ranges from 3 to 6 months. However, the exact duration can vary depending on several factors, such as the completeness of the application, the complexity of the device, and whether HSA requests additional information.

5-Year Renewal Period: The registration for Class B medical devices in Singapore is valid for 5 years from the date of registration. After this period, you will need to renew the registration to continue marketing and distributing the device in Singapore.

Legal Authorization: Registration with HSA provides legal authorization to market and sell your Class B medical device in Singapore. It is a necessary step to comply with the country’s regulations and allows for distribution within the local healthcare system.