The Health Sciences Authority (HSA) Singapore published the latest Medical Devices Product Classification Guide in November 2021, to assist with the classification of certain challenging products.
Medical device (MD) is defined in the First Schedule of the Health Products Act (HPA) and based on this definition, products are classified as MD and are regulated by HSA. For certain products, this process may not be as straightforward, and the guide provides some insight and assistance in relation to this issue.
The guide discusses about the process of classifying a product as a medical device and the importance of determining the intended purpose of the product, by factoring in the design and presentation of the product, as well as the primary mode of action (of the product) by which the intended purpose is attained.
The topics covered are products with medical-related purpose, general purpose products, assistive technology products, products for sports, physical fitness, or general health, as well as personal protective equipment (PPE).
More details can be found in “Medical Devices Product Classification Guide – Medical Devices Cluster, November 2021”: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/gudiance-documents-for-medical-devices/medical-devices-product-classification-guide.pdf