Are medical devices regulated in Singapore?
Medical devices are regulated under the Health Products Act and Health Products (Medical Devices) regulations. Singapore’s Health Sciences Authority (HSA) oversees the system of statutory control aimed to safeguard the quality, safety and efficacy of medical devices available in Singapore. Almost all medical devices are regulated.
What is not considered a medical device?
Similarly, products intended for physical fitness, maintenance of general state of health (ie. weight management, recreational use, sleep management, detoxification, improving and enhancing flow of (qi) are not considered medical devices. PRODUCT(S) CLASSIFICATION REMARKS
Should ASEAN countries adopt uniform classification criteria for medical devices?
This requires ASEAN countries to adopt uniform classification criteria for medical devices. This bodes well for U.S. medical device manufacturers as they will be able to easily access a common medical device market with a market size of more than 600 million people.
Who buys medical equipment in Singapore?
The Health Ministry is the largest consumer, accounting for nearly 75% of local demand. Parkway Hospitals Singapore, the largest private sector healthcare provider in Singapore, is also a significant buyer of medical equipment. More than 80% of local demand is met through imports and there is a premium placed on American-made products.
medical-devices-product-classification-guide.pdf