The healthcare industry is one of the most developed and successful industries in Singapore, at the moment. With a rising number of healthcare facilities, companies operating in this sector have started rising their standards related to the medical equipment and devices they use, which is why they import many of them in order to make sure they provide the best services.
The import of medical equipment in Singapore is subject to very strict regulations imposed by the Medical Device Branch within the Health Science Authority (HSA) in the city-state.
For company formation services in the medical field in Singapore, you can rely on our consultants.
The Health Products Act (HPA) is the law governing both the import and use of medical equipment in Singapore. The legislation classifies medical devices into 4 categories, as it follows:
When importing medical devices into Singapore, the HSA requires companies to comply with certain regulations and to submit various documents related to the products.
All healthcare facilities or other companies distributing medical equipment in Singapore are required to register all the devices they import. In order to do so, they must file an application form with the HSA through the Medical Device Information and Communication Systems. They will receive a Client Registration and Identification Service (CRIS) account through which they will be able to register their products.
Our Singapore company formation agents can offer more information on applying for special licenses and permits when importing goods into the city-state.
Singapore companies importing medical devices registered under one of the four classes are required to submit the following documents with the Customs Authorities:
Based on these documents, a company will obtain its medical device import license.
If you want to open a company in the healthcare industry in Singapore, do not hesitate to contact our company registration representatives.