Medical device registration in Singapore
Singapore’s Health Sciences Authority (HSA) is tasked with regulating drugs, innovative therapeutics, medical devices, and other health products to meet appropriate safety, quality, and efficacy standards, as well as contributing to the development of national drug policies. The HSA evaluates product registration applications, assesses clinical drug trials, and audits good manufacturing and distribution practices in order to grant approvals that allow products to be marketed in Singapore. In the post-market phase, the HSA conducts regulatory surveillance on medical products, enforces actions against illegal activities, and responds to adverse drug events.
How to register for your medical device
Singapore’s Medical Device Regulations
For medical device registrations, the Registrant is required to obtain a dealer’s license from the HSA, as only licensed medical device dealers are allowed to manufacture, import, or sell medical devices in Singapore. Applicants can apply for product registration and the dealer’s license at the same time.
In Singapore, medical devices are classified as either Class A, B, C, or D. Class A devices include simple, low risk tools such as tongue depressors while Class D are complex, high risk objects such as heart valves. All Class A medical devices are exempted from product registration and are to be declared in the public online Class A database. Class B, C, and D devices require registration.
The Singapore Medical Device Register (SMDR) is a database that contains a list of all medical devices that are currently being used on patients. The database is openly accessible by anyone and the public can search for devices by using the device name, product owner, identification number, or hospital.
For medical device registrations, the Registrant is required to obtain a dealer’s license from the HSA, as only licensed medical device dealers are allowed to manufacture, import, or sell medical devices in Singapore. Applicants can apply for product registration and the dealer’s license at the same time.
In Singapore, medical devices are classified as either Class A, B, C, or D. Class A devices include simple, low risk tools such as tongue depressors while Class D are complex, high risk objects such as heart valves. All Class A medical devices are exempted from product registration and are to be declared in the public online Class A database. Class B, C, and D devices require registration.
The Singapore Medical Device Register (SMDR) is a database that contains a list of all medical devices that are currently being used on patients. The database is openly accessible by anyone and the public can search for devices by using the device name, product owner, identification number, or hospital.
Titansmedical can help you with medical device or IVD registration, act as your Authorized representative and support you with distributor identification and importation.
