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.
If you want to open a company in Singapore in the medical field, you can rely on our consultants.
Classification of imported medical devices in Singapore
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:
- – class A devices which are considered low risk products;
- – class B devices which are deemed low-moderate risk products;
- – class C devices which are considered moderate-high risk products;
- – class D devices which are considered high risk products.
When importing medical devices into Singapore, the HSA requires companies to comply with certain regulations and to submit various documents related to the products. One of our experts in company formation matters can give you more details about these requirements and can also assist you if you want to open a company in Singapore in this field.
Registering medical devices in Singapore
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.
The procedure for importing medical devices into Singapore
Singapore companies importing medical devices registered under one of the four classes are required to submit the following documents with the Customs Authorities:
- – a declaration form or the so-called cargo clearance license;
- – a packing list with the names, quantity and batch number for the devices;
- – a Certificate of Analysis (COA) for each product.
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 in Singapore.